Yourlawyer.com (Zoloft News)

Another Study Links Antidepressants To Birth Defects

Fri, 25 Sep 2009 00:00:00 -0700

More emerging research is pointing to links between antidepressant use and a greater chance for a particular heart birth defect, writes WebMD.

A Danish study of over 400,00 children born from 1996 to 2003, found that the risk increased when expectant mothers either take more than one selective serotonin reuptake inhibitor (SSRI) or switch SSRIs in early trimesters, said WebMD. Popular SSRIs include Prozac, Paxil, Zoloft, Celexa, and Lexapro, and are often prescribed to pregnant women suffering from depression, WebMD pointed out.

According to the study, when pregnant women took more than one SSRI, their babies experienced a four-fold increase in septal heart defects, a defect in the wall that divides the heart’s left and right sides, explained WebMD.

As we've reported previously, in late 2005, the U.S. Food & Drug Administration (FDA), sent an alert to physicians about early studies suggesting Paxil could be a contributor to heart defects in babies when taken by expectant mothers in the first trimester. WebMD noted that not only was Paxil singled out by the agency, but also since the warning, doctors are routinely known to switch pregnant women’s medication from Paxil to a different SSRI when pregnant or discussing become pregnant. That early switching has been linked to the infant heart defect. Also, said WebMD, citing recent studies, Paxil does not increase the risk of the specific heart defect versus other antidepressants; the Danish study found that Celexa and Zoloft in early trimesters was associated with the heart defect while the risk was not seen with Paxil or Prozac.

Septal heart defects occurred in 0.5 percent of children born to women not on SSRIs, while 0.9 percent of children born to mothers taking SSRIs were diagnosed with the defect. Lars H. Pedersen of Aarhus University called for larger studies to determine the safety of any one SSRI versus any others during pregnancy.

In a joint statement from the American College of Obstetricians and Gynecologists (ACOG) and the American Psychiatric Association (APA), the groups recommended that women who experience psychotic episodes, have bipolar disorder, are suicidal or have a history of suicide attempts should remain on antidepressants; women suffering from mild depression or who experienced few symptoms for six months or more could consider gradually reducing or stopping SSRI use under close physician supervision; and psychotherapy and other treatments might be an appropriate alternative in some, not all, pregnant women with depression, reported WebMD.

Tamoxifen Label May Finally Warn About Antidepressant Risks

Tue, 02 Jun 2009 00:00:00 -0700

A study that we reported on yesterday that showed that use of some antidepressants-namely Paxil, Prozac and Zoloft-may interfere with the efficacy of tamoxifen, leading to recurrence of breast cancer, has the Food & Drug Administration (FDA) planning to warn doctors of potentially adverse interactions. According to Dow Jones News Wire, it will likely add the information on the interactions to tamoxifen's label.

Tamoxifen is used to prevent the return of estrogen-dependent breast tumors. More than 500,000 women in the U.S. are taking tamoxifen and about 30% of those women are also prescribed antidepressants to treat hot flashes, Dow Jones News Wire said.

Hot flashes are a common side effect of tamoxifen therapy. As we reported yesterday, doctors started using antidepressants for hot flashes after hormone-based treatments were linked to the development of breast cancer. However, treating tamoxifen hot flashes with antidepressants is an off-label use of such drugs.

As we reported yesterday, a study conducted by Medco Health Solutions Inc. and presented over the weekend at the American Society of Clinical Oncology's annual meeting, found breast cancer patients who took an antidepressant like Paxil, Prozac or Zoloft with tamoxifen were more than twice as likely to have their cancer return. The study, which involved 1,300 women, found that those who took such drug combos for one year had a breast cancer recurrence rate of 16% compared to a recurrence rate of 7.5% for women not taking the drugs. However, according to Dow Jones News Wire, not all antidepressants had the same impact, and the study showed women on drugs like Celexa, Lexapro and Luvox didn't have a statistically higher rate of cancer recurrence.

According to a report on Bloomberg.com, tamoxifen works by combining with the CYP2D6 enzyme, which is produced by the liver. This produces endoxifen, a substance known to fight tumors. But some antidepressants, including Paxil, Prozac and Zoloft, block the CYP2D6 to varying degrees, which likely impacts the efficacy of tamoxifen.

Prior to the Medco study, lab studies had shown that some antidepressants could impact tamoxifen. As we reported yesterday, the FDA had already taken a look at interactions between tamoxifen and antidepressants. According to Bloomberg.com, the 2006 review concluded that data on the effect should be added to tamoxifen labeling; however, to date, there is no such statement on this risk on the medication’s label.

According to Dow Jones News Wire, Larry Lesko, director of the FDA's Office of Clinical Pharmacology, said now that the FDA has evidence about clinical outcomes as a result of the drug interaction, it will likely add that information to tamoxifen's label.

Antidepressants Linked to Sudden Cardiac Death in Women

Wed, 11 Mar 2009 00:00:00 -0700

A new study has concluded that women with no history of cardiac problems but who use antidepressants are at an increased risk for sudden cardiac death (SCD). HealthDay News reports that the reason for the link remains unknown, according to the researchers whose findings were published in the Journal of the American College of Cardiology.

"We suspect that their use is a marker for people with worse depression," explained the study’s lead author Dr. William Whang, an assistant professor of clinical medicine at Columbia University Medical Center in Manhattan. "The elevated risk seems more specific for antidepressant use, but that use may well be a marker of more severe symptoms," quoted HealthDay News. Whang noted that the link seemed to be physiological saying, “We found that women who had worse depressive symptoms had higher rates of risk factors such as hypertension, diabetes, and smoking.” As a matter-of-fact, the report indicated, said HealthDay News, women with clinical depression were at a two-fold risk of experiencing SCD.

The researchers looked at over 63,000 American women in the Nurses Health Study, said HealthDay, with no history of previous stroke or heart disease from 1992 to 2004, said Natural News, and found a link between depression and heart risk; however, the link between SCD and antidepressants was significantly more pronounced. Also, antidepressant use was not linked with an increased risk of cardiac arrest over fatal heart disease, only with the increased risk of SCD, reported HealthDay News. Prior research established the link between depression and an increased risk of death for those with heart disease, explained Whang, who noted, "But this was a group of women without heart disease, and that makes it different," said HealthDay News.

Natural News pointed out that the study found women with the highest risk for SCD and fatal coronary heart disease (CHD) expressed the most severe depression symptoms or were on antidepressant therapy. "We can't say antidepressant medications were the cause of higher risk of sudden cardiac death. It may well be that use of antidepressants is a marker for worse depression," said Whang, reported Natural News. "The biggest clinical implication is that management of coronary heart disease risk factors may be especially important for those with depressive symptoms. Taking care of those risk factors can modify the risk for coronary disease," warned Whang, according to HealthDay News.

To determine which women suffered from depression, the team reviewed their self-reported depression symptoms and use of antidepressants, for instance, Prozac, said Natural News. A link was clearly present with serious heart rhythm problems, which include those causing sudden death, said HealthDay News. The American Heart Association explained, said Natural News, that SCD causes sudden death from an unexpected loss of heart function.

SSRI antidepressants, such as Prozac, Lexapro, Zoloft, and Paxil have been described as safe for the heart; however, a number of cardiovascular side effects, such as irregular heart rhythms and potentially lethal arrhythmias, are known to occur in some taking these medications, said Natural News, noting that Prozac maker, Eli Lily, lists a variety of adverse cardiac symptoms on the official package insert for physicians.

Supreme Court Revives Antidepressant Lawsuits

Tue, 10 Mar 2009 00:00:00 -0700

In the wake of last week’s Supreme Court decision that protected the rights of patients to sue drug makers for liability in state courts, two lawsuits are receiving particular attention. Bloomberg News reports that Pfizer and a GlaxoSmithKline PLC unit are being blamed for not warning that their antidepressants—Zoloft and Paxil—might provoke suicidal ideation and suicide in adults.

The two justices ordered the U.S. Court of Appeals for the Third Circuit in Philadelphia—which previously rejected the suits—to reconsider following the recent Supreme Court decision allowing such suits to be tried in state courts. The suits were filed by the family of a woman who committed suicide after taking Glaxo’s Paxil and a man who committed suicide after taking Pfizer’s Zoloft, said Bloomberg; both suits are among hundreds filed against drug makers. The justices also asked for reconsideration of a prior rejection of a false advertising suit involving AstraZeneca PLC’s Nexium anti-ulcer drug.

In 2005, for the first time, the Food & Drug Administration (FDA) required antidepressant package warnings aimed at doctors and patients regarding suicide risks in children; in 2007, the warning was broadened to include people ages 18 to 24, said Bloomberg. In 2006, the FDA proposed expanding the labels of all antidepressants to include a warning of suicidal thoughts in patients ranging from 18-24 years of age and a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment. In 2006, Glaxo and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too, and changed the drug’s label to reflect that risk.

The FDA has urged the makers of Zoloft and other SSRI (selective serotonin reuptake inhibitors) antidepressants to add a warning about suicidal behavior and has said that patients using Zoloft and other antidepressants should be watched closely for suicidal tendencies. The expanded warnings on antidepressant labels advise health-care providers to "carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either decreases or increases."

Suicide is the fourth leading cause of death for those aged 18 to 65 and the third leading cause for those aged 15 to 24 in the United States. Add to those figures the complexity of medications. In recent years, disturbing reports have suggested that side effects of some popular drugs—Chantix, Accutane, Singulair, Zoloft, and Paxil—include suicidal thoughts and behavior.

Reports have been filed with drug makers and the FDA on at least six drugs or drug classes that may be linked to suicide or suicidal ideation and the FDA released notices last year about several such medications including Singlulair; epilepsy drugs including carbamazepine, gabapentin, felbamate, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, and valproate; and the smoking-cessation drug Chantix. Reports have been filed on SSRI antidepressants including Paxil and Prozac, the influenza drug Tamiflu, and the acne medicine Accutane. “The brain is a complex organ, and most of the drugs are complex as well,’’ said Dr. Thomas Laughren, head of the division of psychiatric products at the FDA, in a report last year. “It’s not unreasonable to think that a drug that gets into the brain may have effects other than you hope they would.’’

American Children Take the Most Psychotropic Drugs

Fri, 26 Sep 2008 00:00:00 -0700

A new study reports that American children are about three times likelier to be prescribed psychotropic medications than children in Europe. The study states that the differences may be attributable to regulatory practices and cultural beliefs about the role of medication in emotional and behavioral problems.

Julie Zito led the team comprised of researchers from the U.S., Germany, and the Netherlands. The group investigated prescription levels in the three countries. Zito reported that, "Antidepressant and stimulant prevalence were three or more times greater in the U.S. than in the Netherlands and Germany, while antipsychotic prevalence was 1.5 to 2.2 times greater." The use of antidepressants, such as Prozac, and stimulants, such as Ritalin, in children has been the subject of much controversy; this study is believed to quantify the differences in practice between the US and Western Europe.

Study authors believe the differences may be partly due to different diagnostic classification systems. For instance, "The US trend of increasing bipolar diagnosis in children and adolescents does not reflect European practice." The team also discussed government cost restrictions in Europe, the increased amount of child psychiatrists per capita in the U.S., as well as the U.S. practice of using two or more different psychotropic drugs in a single year as possible explanations. "Direct to consumer drug advertising, which is common in the U.S., is also likely to account for some of the differences. The increased use of medication in the US also reflects the individualist and activist therapeutic mentality of US medical culture," Zito added.

Earlier this month we reported about one million children and teenagers are treated for schizophrenia and prescription rates for atypicals—the anti-psychotic drugs most prescribed for these disorders—have increased more than five-fold for children over the past 15 years and are also being used to control outbursts and aggression in children with a wide variety of diagnoses representing about 80 percent of the prescriptions written for maladies such as autism, ADHD, bipolar disorder, depression, and anxiety, despite the drugs’ serious side effects. Some uses are off-label, or not approved by the Food and Drug Administration (FDA). Approximately three million Americans suffer from schizophrenia and about 20 percent begin to show symptoms as children or teens.

Meanwhile, state officials are finding atypical antipsychotics have become the largest drug class in Medicaid and many question if this is due to marketing or need; several states are suing drug makers for off-label promotion and commissioning "ghost-written" articles to increase use. But, drug makers continue to obtain new approvals from the FDA to treat more conditions. In the last two years, Risperdal received approval to treat schizophrenia in adolescents and the irritability of autism in children ages five to 16. Nicola Huff, whose son, John Aaron, took Risperdal for seven years to resolve behavioral problems said at age 14, he developed female-sized breasts that had to be surgically removed. Tammy Wandling, whose son Austin has autism, said a psychiatrist put him on Risperdal at age four. In less than nine months, Austin developed a baseball-size growth in his right breast. Research suggests Risperdal can cause an increase in the hormone prolactin, which causes breasts to enlarge and produce milk.

Did Drug Company Payments to Doctor Play a Role in Child's Suicide?

Fri, 27 Jun 2008 00:00:00 -0700

Mathy and Andy Downing’s daughter, Candace, hanged herself five years ago when she was just 12 years old. Candace seemed to be a happy girl and left leaving no note or indication as to what had caused the drastic change. According to her father, “We had no warning. Absolutely no warning."

The Downings blame Candace's suicide on the antidepressant drug Zoloft and are seeking answers as to why their physician, Matheme Selassie, prescribed the powerful drug to a child whose only complaint was some anxiety over school. Now, it turns out, some answers may be found in their physician’s activities. Selassie was paid around $12,000 to make speeches hyping Zoloft, with some of the payments from Zoloft drug maker Pfizer. The Downings believe the money influenced the prescription.

In an interview with CBS News correspondent Wyatt Andres, Andrews asked Candace’s mother, "Did the doctor tell you he was taking Pfizer money?" "Absolutely not," she said. "How dare he! How dare he take money for a medication that killed our daughter?"

Unfortunately, the Downing case is not an isolated incident and there is a strong chance that your doctor, or doctors, benefit(s) from drug companies outside of free drug samples and pens and coffee mugs. According to recent estimates reported from a University of Quebec study, drug company payments to doctors reach into the billions annually, as high as $57 billion a year. Payments cover consulting fees, speaking fees on drugs, and medical seminars on the benefits of drugs. Here’s what this means: Big pharmaceutical is spending significantly more money on marketing to physicians than it is spending on advertising.

Many feel such payouts should be reported, including Senator Charles Grassley—Republican-Iowa—who said, "If they are being paid, it ought to be reported. Grassley is also looking at the money drug companies pay doctors for academic research and is investigating about 20 of the top medical schools, including Harvard, Stanford, and the University of Cincinnati, for under-reporting the income top researchers are receiving from the drug industry. Grassley wants to learn if industry money is influencing research.

And it may be. Look at the recent Harvard case wherein Dr. Joseph Biederman—a leader in pediatric bipolar research whose research led to huge increases in bipolar diagnoses in children as well as the drugs to treat those children—is being investigated for allegedly failing to report an incredible $1.6 million in fees from drug companies. Grassley’s response? "Well, it raises a flag to me that they might have something to hide," he said. "It raises a flag that the university doesn't care."

Biederman told CBS News that some of that industry money was "not personal income," and that his life's work is devoted solely "to rigorous and objective study." And, while some doctor-big pharmacy relationships are legitimate and even necessary for ongoing research. Grassley says the answer is more public information. Grassley and some other senators has proposed a law requiring drug companies to publicly report any payments to doctors exceeding $500 on a government Web site.

Published Antidepressant Studies Exaggerate Their Effectiveness

Thu, 17 Jan 2008 00:00:00 -0800

Antidepressants like Effexor, Zoloft, Wellbutrin and Paxil, may not be as effective in treating symptoms of depression as once thought. That’s because studies done on many popular antidepressants have been skewed in a way that exaggerates their effectiveness. In many cases, only research that casts antidepressants in a favorable light is published.   Meanwhile, studies with less-than-favorable results are often mothballed by the pharmaceutical companies that make antidepressants.

The overwhelming amount of published research on antidepressants show that these drugs are effective in treating depression and other psychological problems. But according to an article in the New England Journal of Medicine, these published studies don’t tell the whole story. According to a data review submitted to the Food & Drug Administration (FDA), the vast majority of unpublished antidepressant studies found the drugs to be less effective than those that made it into medical journals.

According to the New England Journal of Medicine, of 74 antidepressant studies reviewed, 38 were deemed favorable to antidepressants.   Of those favorable studies, all but one where published. Of the unfavorable studies, 22 of 36 where never published. Even more outrageous, of the 14 unfavorable studies that were published, at least 11 mischaracterized the results and presented a negative study as positive.

The antidepressant studies that the New England Journal of Medicine looked at involved some of the most popular drugs on the market. For example, in five clinical trials done on the Pfizer drug Zoloft, two published studies showed Zoloft appeared to work better than the placebo. But in three other Zoloft trials, the placebo did just as well at reducing indications of depression. Pfizer never published the three unfavorable studies, and the company discusses only the positive results in Zoloft's literature for doctors.

Even when studies where published, researchers found that drug companies found ways to manipulate them to make findings appear more favorable to an antidepressant than they really where. For example, sometimes drug makers ignore or downplay a negative finding for the "primary outcome" -- the main question the study was designed to answer -- and highlight a positive secondary outcome. In nine of the negative studies that were published, the authors simply omitted any mention of the primary outcome, the researchers said.

According to The Wall Street Journal, sales of antidepressants total about $21 billion a year. Considering this, it is understandable that drug makers would want to protect these sales.   But suppressing the results of unfavorable studies affects more than antidepressant sales. Doctors unaware of the unpublished data are making inappropriate antidepressant prescribing decisions that aren't in the best interest of their patients. Sales of antidepressants are so huge because doctors and patients have been given the wrong impression about their effectiveness. "There is a view that these drugs are effective all the time," Dr. Erick Turner, a lead researcher on the study, told the Wall Street Journal. "I would say they only work 40% to 50% of the time."

FDA Again Warns About Suicidal Thoughts and Behavior Among Young Adults on Antidepressants

Thu, 03 May 2007 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) today issued new warnings about suicidal thoughts and behavior related to young adults taking antidepressants, and they have asked drug makers to update their label warnings appropriately.

The FDA uses the term “suicidality” to describe what they call suicidal thinking and behavior. The new “black-box” label warnings, the most strident type of warning, would reflect the increased risks of suicidality in young adults, ages 18 to 24, during the initial stages of treatment, which usually encompasses the first couple of months.

“Today’s actions represent FDA’s commitment to a high level of post-marketing evaluation of drug products,” said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks.”

The updated warnings would, naturally, include several mitigating points as well. The new labels would stress the fact that the increased risk of suicidality has not been scientifically proven among patients older than 24, and also that patients older than 65 have actually been shown to have a decreased risk of suicidal thoughts and behavior when taking antidepressants. The warnings would also include language reminding consumers about the serious risks associated with untreated depression and other psychiatric disorders.

However, the FDA made it clear that the new warnings apply to “the entire category of antidepressants” and that available data “are not sufficient to exclude any single medication from the increased risk of suicidality.”

The FDA mandated similar labeling changes to antidepressants in 2005, but those warnings were specific to the suicidality risk in children and adolescents only. Since that time, the FDA has attempted to ascertain the risk of suicidality in adults taking antidepressants by conducting comprehensive reviews of 295 individual antidepressant trials that included more than 77,000 adult patients with major psychiatric disorders. Five months ago, the FDA’s Psychopharmacologic Drugs Advisory Committee recommended that the label warnings be updated to include young adults, but only now has the FDA taken any decisive action.

The drugs associated with the new label warnings are:
Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

Wed, 02 May 2007 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.

The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.

The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.

In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.

FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.

Products involved in today's action include:

Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)

FDA plans to expand antidepressant warning

Thu, 14 Dec 2006 00:00:00 -0800

A Food and Drug Administration federal panel Wednesday recommended the agency issue its strongest possible warning to alert patients and doctors that antidepressants can increase the risk of suicidal thoughts and behavior in young adults.

The panel called for placing the so-called black-box warning on product labels and in medication guides distributed to patients.

Following the vote, FDA officials said they intended to expand the warning to include young adults.

Since 2004, antidepressants have had a black-box warning about an increased risk of suicidal thoughts and behavior in children and adolescents.

The recommendation to extend that warning to patients in their late teens and 20s came after the FDA's review of 372 clinical trials. The review found the risks were related to age and the dangers seemed to disappear at age 25.

Still, some panel members said that 25 seemed like an arbitrary cutoff and that the risks for a 25-year-old were probably not much different from those for a 24-year-old.

"I am concerned that there is a false sense of security to some of these age brackets," said panel member Dr. Marcia J. Slattery, a University of Wisconsin psychiatrist.

She said all patients taking antidepressants should be monitored for signs of suicidal thoughts and behavior.

In the end, the panel decided to leave the age limit of the warning for the FDA to decide. Patients younger than 25 account for about 8% of all antidepressant prescriptions.

The panel's 6-2 vote came amid concerns the black box might discourage young adults who need help from using the drugs, which many doctors said were among the most effective treatments for depression.

Several panelists called for balancing the warning with a statement underscoring the necessity of treating depression.

"We are dealing with a very vulnerable population," said panel member Gail W. Griffith, a patient representative from Washington.

The FDA's review, which looked at 100,000 patients, found a small but significant risk of suicidal thoughts and behavior among 18- to 24-year-olds who took antidepressants. The agency said that four of 1,000 patients were at increased risk.

The FDA study found no increased risk for patients ages 25 to 30. The drugs seemed to protect against suicidal thoughts and behaviors after age 30 and particularly after age 65, the agency said.

The FDA had no explanation for the apparent age-related effects of antidepressant drugs.

Half of the patients studied took the drugs for depression, while the rest were testing the medicines for psychological disorders, such as anxiety, or behavior modification, including smoking cessation and obesity.

Across all the studies, eight people committed suicide, 134 attempted suicide and 528 thought about killing themselves or prepared to do so. The FDA said suicides were too infrequent to draw any association to the drugs.

The research focused on 11 commonly used antidepressants: selective serotonin reuptake inhibitors Celexa, Lexapro, Luvox, Paxil, Prozac and Zoloft; serotonin-norepinephrine reuptake inhibitors Cymbalta and Effexor; other antidepressants Remeron, Serzone and Wellbutrin.

The panel's decision applies to all antidepressants, including an older class known as tricyclics.

About 19 million people in the U.S. have depression and 16 million are treated with antidepressants, according to Mental Health American, an advocacy group.

The vote came after an emotional hearing in which family members pleaded for strong warnings on drugs that they believed had caused loved ones' suicides.

"We deserve to be told all the side effects," said Kim Witczak of Minneapolis, whose husband, Woody, 37, hanged himself in 2003 after being prescribed Zoloft for insomnia.

But members of medical associations argued against the black box, saying it could indirectly lead to an increase in suicides because doctors might be afraid to prescribe the drugs for people who need them.

Dr. Carolyn Robinowitz, president of the American Psychiatric Assn., said suicides among 10- to 14-year-olds rose 16% to 244 in 2004 as antidepressant prescribing fell in advance of the FDA warning about suicidal thoughts and behaviors in adolescents.

"The black box has had unintended consequences," she said. "Depression can be lethal."

Last year, prescriptions for antidepressants fell 13% among children and adolescents and 8% among adults under 25, according to the prescription-tracking firm Verispan.

Study shows pills raise suicide risk in young adults

Thu, 14 Dec 2006 00:00:00 -0800

Widely used antidepressants double the risk of suicidal behavior in young adults, from around three cases per thousand to seven cases per thousand, according to a federal analysis of hundreds of clinical trials. It marks the first time regulators have acknowledged that the drugs can trigger suicidal behavior among patients older than 18.

Officials at the Food and Drug Administration said Wednesday that the higher risk was found in patients between 18 and 25 and that the risk faded among older patients. The finding comes two years after the agency ordered a ''black box'' warning on the drug labels after the discovery of a heightened risk of suicidal behavior among children taking the pills.

After reviewing the latest data, an expert federal panel on Wednesday recommended that agency officials tell doctors and the public of the risk but also find a way to note that the risk declines with age, and that leaving depression untreated also is risky.

While the studies on the relationship between the drugs and suicide appear contradictory, the experts said one possibility is that the drugs may pose a risk early in treatment but have a protective effect in the long term.

The agency is leaning toward expanding its black box warning, said Thomas Laughren, director of FDA's division of psychiatric drug products. Officials said they will try to craft language that would urge clinicians to use the drugs carefully, not abandon them.

The new finding created a dilemma for the regulators. Even as it vindicated some of what critics of drugs such as Prozac, Paxil and Zoloft have said for years, the earlier official warnings about the drugs appear to have led to a drop in their use and there are troubling signs that this can lead to an increase in suicides.

After concerns were raised in the Netherlands about the suicide risk, there was a 22 percent drop from 2003 to 2005 in antidepressant prescriptions for patients younger than 18 and a 50 percent increase in suicides, said Robert Gibbons, a professor of psychiatry at the University of Illinois in Chicago. The number of suicides went from 34 to 51.

''What we are seeing is the early signs of an epidemic of suicide in children who are no longer being treated for their depression,'' Gibbons said in an interview. U.S. suicide data for 2005 is not yet available, but Gibbons said the FDA's black box warning had caused a similar decline in prescriptions among children here. He predicted dozens of additional suicides as a result and warned that any expansion of the black box would have a similar impact on adults.

Robert Temple, director of FDA's Office of Medical Policy, said regulators were in a bind. On the one hand, they need to tell physicians about the new results in order to warn them to monitor patients closely for suicidal behavior, but if that means doctors stop prescribing the drugs altogether, ''I don't know what you are supposed to do.''

FDA may expand antidepressant warning

Wed, 13 Dec 2006 00:00:00 -0800

Treatment with antidepressants increases the risk of suicidal thoughts and behavior in patients age 24 and younger, according to proposed changes to the drugs' labels unveiled Wednesday by federal health officials.

The proposed changes would expand a warning now on the labels that applies only to children and adolescents treated with the drugs.

The Food and Drug Administration put forth its plan to update the drug labels early Wednesday at the start of a meeting of outside advisers convened to discuss the proposal. The changes also would include a recommendation that patients of all ages be carefully monitored, especially when beginning antidepressant treatment.

Mental health experts are worried that additional warnings about the risk of suicides linked to antidepressants could curtail their use and ultimately do more harm than good.

The proposed changes come on the heels of an FDA review that found use of the drugs may increase the risk of suicidal thoughts and behavior among young adults ages 18 to 24.

But adding "black box" or other warnings to the drugs could scare away doctors, parents and patients, mental health experts caution. They warn that people with untreated depression about half of those who suffer from the disease face an estimated 15 percent greater likelihood of death by suicide.

"My concern is that by not simply promoting good standards of care and by putting on a black-box label, the FDA may unwittingly limit further access to care," said Dr. Carolyn Robinowitz, president-elect of the American Psychiatric Association.

However, use of antidepressants continues to grow, with nearly 190 million prescriptions dispensed in the United States last year, according to IMS Health, a health care information company. That suggests doctors have placed more weight on the long-term benefits of the drugs than on any short-term risks, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told panelists.

The FDA recently completed a mass review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated but short-term risk for suicidal thoughts and behavior among adults 18 to 24 that approaches that seen in children, the FDA said in documents released before Wednesday's meeting of its psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related shift in the risk of suicidal thoughts and behavior associated with treatment with the drugs. For instance, antidepressants seem to protect against suicidal thoughts and behavior in adults 30 and older, with the effect most pronounced in patients over 65.

In May, GlaxoSmithKline and the FDA warned Paxil may raise the risk of suicidal behavior in young adults and changed the drug's label to reflect that risk.

Already Linked to Suicide, New Research Links SSRI Antidepressants with Violence

Mon, 11 Sep 2006 00:00:00 -0700

New research has linked antidepressants, known as selective serotonin reuptake inhibitors or SSRIs, with violent episodes. Researchers found people who took the antidepressant Paxil were twice as likely to have a violent or “hostility event” as those given a placebo. Controversy is nothing new to SSRIs, in 2004 the FDA required the warning labels on these drugs to contain language about suicide risks.

The researchers used data from Britain’s Committee on Safety of Medicines Expert Working Group, legal cases and e-mails from 1,374 patients in response to a British television program on the subject. They found that 60 out of 9,219 people who took Paxil or 0.65 percent, had “a hostility event,” compared to 20 of 6,455 given a placebo, or 0.31 percent. The research appeared online in the journal Public Library of Science-Medicine.

Popular SSRIs include: Celexa, Lexapro, Prozac, Paxil, Zoloft and Luvox. It is still not exactly known why SSRIs help treat depression. It is believed that neurotransmitters, including serotonin, are associated with depression. SSRIs seem to help symptoms of depression by blocking the reabsorption (reuptake) of serotonin by certain nerve cells in the brain. This leaves more serotonin available, which enhances neurotransmission and helps treat depression.

www.newsinferno.com

FDA Warns of Suicide Risk for Paxil

Fri, 12 May 2006 00:00:00 -0700

The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the
Food and Drug Administration warned Friday in a letter to doctors.

The warning letter was accompanied by changes to the labeling of both Paxil and Paxil CR, a controlled-release version of the drug, also called paroxetine.

A recent analysis of clinical trial data on nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.

The FDA reported that there were 11 suicide attempts none resulting in death among the patients given Paxil in the trials. Just one of the dummy pill patients attempted suicide.

Given that small number, the results "should be interpreted with caution," the FDA said. Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.

A GlaxoSmithKline spokeswoman did not immediately return a message seeking comment. However, in the letter to doctors, Dr. John E. Kraus, the company's director of clinical development for clinical psychiatry in North America, said GlaxoSmithKline continues to believe the drug's benefits outweigh its risks.

The FDA stressed that all patients, especially young adults and those who are improving, should be carefully monitored when treated with Paxil.

In 2004, the FDA ordered strong warnings about the pediatric risk of suicidal tendencies put on antidepressant labels, and began analyzing whether adults face a similar risk.

All antidepressants now carry warnings on their labels cautioning patients and doctors of the risk of suicidal behavior.

Health Canada Issues Advisory Regarding Link between Newer Antidepressants and Life-Threatening Respiratory Condition

Sun, 12 Mar 2006 00:00:00 -0800

Health Canada has issued a strongly worded “Advisory” to women who are taking newer antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRIs) and who are pregnant or intend to become pregnant.

They are being advised to discuss the situation with their doctor due to potential life-threatening risks to their babies.
Equally important is the fact that patients taking SSRIs should not stop taking them without first consulting their doctors, as abrupt termination of these medications can cause them to experience serious side effects.

According to the advisory: “Generally, SSRI treatment should only be continued if the benefits to the individual patient are thought to outweigh the risks to the unborn child, while also considering the benefits and risks of switching to another treatment option or stopping treatment altogether.”

SSRIs and other newer antidepressants prescribed for the treatment of depression include the following drugs: Wellbutrin (bupropion), Celexa (citalopram), Cipralex (escitalopram), Prozac (fluoxetine), Luvox (fluvoxamine), Remeron (mirtazapine), Paxil (paroxetine), Zoloft (sertraline) and Effexor (venlafaxine), and Zyban (bupropion) for smoking cessation.

A recent study published in the New England Journal of Medicine suggests that “use of SSRIs during the second half of pregnancy may be associated with a serious condition called persistent pulmonary hypertension of the newborn.”

Newborns with this rare but life-threatening condition do not receive enough oxygen in the blood and require intensive-care treatment to survive.

According to the study, babies born with this condition were six times more likely than healthy babies to have been exposed to SSRIs. This information is still considered to be preliminary.

Numerous reports in Canada and abroad have already indicated that some children exposed to SSRIs and other newer antidepressants during pregnancy may develop serious complications at birth.

“An increase in the overall risk of major birth defects has also been associated with SSRI use.”

Health Canada intends to “vigilantly” monitor the situation and issue additional advisories “if new concerns arise.”

Health Canada advisories on other SSRI-related complications in newborns are available on the Health Canada website (see August 9, 2004, October 6, 2005 and December 22, 2005).

Health Canada stresses that: “Managing the adverse reactions of marketed health products depends on the active participation of both healthcare professionals and consumers in reporting these reactions. The spontaneous reporting of adverse reactions generally underestimates the risks associated with the use of marketed health products.”

To report a suspected adverse reaction to SSRIs or other newer antidepressants, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 866-234-2345; Facsimile: 866-678-6789; CADRMP, Marketed Health Products Directorate, Health Protection Building, Tunney’s Pasture, AL 0701C; Email: cadrmp@hc-sc.gc.ca

Consumers requiring more information about this advisory can contact the Health Canada public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

SSRI Antidepressants Linked To Serious Lung Disorder in Newborns

Fri, 10 Mar 2006 00:00:00 -0800

Health Canada is advising women who are taking antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRI) and who are pregnant or intend to become pregnant to discuss the situation with their doctor due to potential risks to the baby.

Health Canada stresses that patients should not stop taking SSRI medication without first consulting their doctors, as they could experience serious side effects.

Generally, SSRI treatment should only be continued if the benefits to the individual patient are thought to outweigh the risks to the unborn child, while also considering the benefits and risks of switching to another treatment option or stopping treatment altogether. These precautions and the possibility of adverse health effects in newborns are mentioned in the current Canadian prescribing information and consumer information for SSRIs.

SSRIs and other newer antidepressants prescribed for the treatment of depression include the following drugs:

Wellbutrin (bupropion)
Celexa (citalopram)
Cipralex (escitalopram)
Prozac (fluoxetine)
Luvox (fluvoxamine)
Remeron (mirtazapine)
Paxil (paroxetine)
Zoloft (sertraline)
Effexor (venlafaxine)
Zyban (bupropion) for smoking cessation

A study published recently in the New England Journal of Medicine suggests that use of SSRIs during the second half of pregnancy may be associated with a condition called persistent pulmonary hypertension of the newborn. Newborns with this rare but life-threatening condition do not receive enough oxygen in the blood and require intensive-care treatment to survive. According to the study, babies born with this condition were six times more likely than healthy babies to have been exposed to SSRIs. This information is considered to be preliminary at this time.

Numerous reports in Canada and abroad have already indicated that some children exposed to SSRIs and other newer antidepressants during pregnancy may develop serious complications at birth. An increase in the overall risk of major birth defects has also been associated with SSRI use.

America's Top-Selling Prescription Drugs – a Who's Who of Blockbusters

Sat, 04 Mar 2006 00:00:00 -0800

According to a recent article in Forbes.com (2/27/06) that was based on figures obtained from IMS Health, a healthcare information company, the top 20 prescription drugs in the U.S. in 2005, with combined sales of $64.6 billion, were as follow:

1.    LIPITOR – Pfizer – Treats high cholesterol: $8.4 billion

2.    ZOCOR – Merck –Treats high cholesterol: $4.4 billion

3.    NEXIUM – AstraZeneca – Treats heartburn: $4.4 billion

4.    PREVACID – Abbott & Takeda – Treats heartburn: $3.8 billion

5.    ADVAIR DISKUS – GlaxoSmithKline – Treats asthma: $3.6 billion

6.    PLAVIX – Bristol-Meyers Squibb & Sanofi-Aventis – Treats heart disease $3.5 billion

7.    ZOLOFT – Pfizer – Treats depression: $3.1 billion

8.    EPOGEN – Amgen – Treats anemia: $3.0 billion

9.    PROCRIT – Johnson & Johnson – Treats anemia: $3.0 billion

10.    ARANESP – Amgen – Treats anemia: $2.8 billion

11.    ENBREL – Amgen & Wyeth – Treats rheumatoid arthritis: $2.7 billion

12.    NORVASC – Pfizer – Treats high blood pressure: $2.6 billion

13.    SEROQUEL – AstraZeneca – Treats schizophrenia: $2.6 billion

14.    EFFEXOR XR – Wyeth – Treats depression: $2.6 billion

15.    ZYPREXA – Eli Lilly – Treats: schizophrenia: $2.5 billion

16.    SINGULAIR – Merck – Treats asthma and allergies: $2.5 billion

17.    PROTONIX – Wyeth – Treats heartburn: $2.4 billion

18.    RISPERDAL – Johnson & Johnson – Treats schizophrenia: $2.3 billion

19.    NEULASTA – Amgen – Treats chemotherapy side effects: $2.2 billion

20.    REMICADE – Johnson & Johnson – Treats rheumatoid arthritis: $2.2 billion

Study: Antidepressants pose risks for newborns

Thu, 09 Feb 2006 00:00:00 -0800

A UCSD study released today is fueling concerns about the effects of certain antidepressant drugs on pregnant women, saying that their use late in pregnancy can significantly increase the chance of deadly lung problems in newborns.

Normally, the lung disorder is rare, with one to two per 1,000 births. But when pregnant women took the drugs in question after the 20th week of pregnancy, the incidence rose to six to 12 per 1,000 births, a report by Dr. Christina Chambers and colleagues at UC San Diego found.

The antidepressants that increased that risk are in a class called SSRIs or selective serotonin reuptake inhibitors. They include citalopram, fluoxetine, paroxetine and sertraline sold under 19 brand names, including Celexa, Prozac, Paxil and Zoloft.

Babies born with the lung disorder, persistent pulmonary hypertension or PPH, often require mechanical assistance to breathe. Between 10 percent and 20 percent will die soon after birth, while others will have developmental delays, hearing loss and brain abnormalities.

Chambers said she didn't want pregnant women now taking the drugs to become scared.

“Ninety-nine women in 100 who take SSRIs late in pregnancy will not have a baby with PPH, so the risk is fairly low,” Chambers said. “But the risk is higher than if the women don't take the drugs, so I think it's important to get the information out there so health providers and women aren't navigating in the dark.”

In a Washington news conference yesterday, a U.S. Food and Drug Administration official called Chambers' findings significant and “worrisome,” especially because 10 percent to 15 percent of women of reproductive age have major depression and are the biggest users of antidepressant drugs.

Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, added that the report comes only a few weeks after a flurry of other large studies on other problems with antidepressants, particularly SSRIs.

Kweder said the FDA will issue a “public health advisory” in the next few days that may include a recommendation that manufacturers of antidepressant drugs conduct additional safety studies.

Women should not go off their antidepressants cold turkey, Kweder said.

“Don't panic,” she said, adding that women with concerns should talk to their doctors. A decision about whether to stop taking the drugs should take into account the severity of the depressive symptoms that prompted the prescription.

“Stopping these medicines on your own can sometimes create more problems than it solves,” Kweder said. “Often these medicines are associated with withdrawal symptoms, which can be problematic for many patients.”

Recent reports have linked SSRIs and other antidepressants with problems in newborns such as not eating properly, jitters and seizures. One study published last week in The Archives of Pediatrics & Adolescent Medicine said 30 percent of infants exposed to SSRIs in the womb develop sugar imbalance, sleep disturbances and difficulty eating that show up like the symptoms of drug withdrawal.

In December, the FDA warned that the use of one SSRI, paroxetine sold as Paxil, during the first trimester is associated with increased risk of birth abnormalities such as cardiac defects.

Another study published last week in the Journal of the American Medical Association dispelled a previously held belief that hormonal and other biochemical changes in pregnant women somehow protected them from clinical depression.

Dr. Lee S. Cohen, a psychiatrist at Massachusetts General Hospital and lead author of the report, wrote that 68 percent of women who discontinued antidepressant treatment after getting pregnant had a significant relapse into depression before giving birth.

Published reports suggest that the use of antidepressants by pregnant women results in some negative impact for as many as 30 percent of their newborns, although most of the time the problems are short-lived and reversible.

“Most studies have not suggested a smoking gun for long-term problems with the use of SSRIs,” said Dr. James Mills, a researcher with the National Institute of Child Health and Human Development. “But that's not true for PPH. In that group (of newborns) the story is very different” because PPH is so serious.

In Chambers' study, the higher incidence of PPH did not occur in women who took non-SSRI antidepressants. These include tricyclics such as amitriptyline sold as Elavil, bupropion sold as Wellbutrin, venlafaxine sold as Effexor and trazodone sold as Desyrel.

The higher risk also was not seen in women who stopped taking SSRIs by the 20th week of pregnancy, her study found.

Asked if she she would take an SSRI if she were pregnant and depressed, Chambers said that it would depend on how depressed she was, what other coping mechanisms were available and whether she were given options for alternative medications.

She stressed that more research is needed to look further into the future for children exposed in the womb to antidepressants.

Chambers urged the FDA and drug companies to develop “better information about this group of antidepressants, and as it is developed it needs to be disseminated.”

The UCSD study, done with colleagues in Boston, Toronto and Philadelphia, is published in today's New England Journal of Medicine. Participants were enrolled from more than 100 hospitals, including 17 in San Diego County.

As they read Chambers' study, San Diego area psychiatrists yesterday said they were rethinking the way they prescribe this class of medication to patients who may be thinking of having children.

But sometimes they have no choice, they said, in the case of a patient who is severely depressed and for whom other categories of antidepressants don't work.

“Sometimes there is no other way to help a woman who is in a severely restless and agitated state,” said Dr. Rodrigo Munoz, a psychiatrist and former president of the San Diego County Medical Society.

“No doubt giving the woman any medication during pregnancy is taking a risk.”

Mission Valley psychiatrist Dr. Catherine Moore said she takes into account how sick her patient is.

“Some women are so depressed, they're not eating well, and that may have an effect on a baby's low birth weight or cause developmental delays,” Moore said.

That absolutely needs to be taken into account, she said.

The FDA's Kweder said the Chambers study, added to the others, “absolutely highlights the critical need for more and better information about the safety and best uses of drugs during pregnancy.

“What you're seeing is that our society's increasing reliance on pharmaceuticals is finally extending to pregnant women, but there's a paucity of information designed to look at this in a systematic way,” Kweder said.

Antidepressants May Harm Newborns' Lungs

Wed, 08 Feb 2006 00:00:00 -0800

New research has linked the use of Prozac and other similar antidepressants during pregnancy to yet another complication in newborns: an uncommon but life-threatening lung problem.

Infants whose mothers took the antidepressants in the second half of pregnancy had six times the expected risk of developing the lung disorder, the researchers reported in Thursday's New England Journal of Medicine.

The antidepressants implicated are called selective serotonin reuptake inhibitors, or SSRIs, a class of drugs that includes Prozac, Paxil and Zoloft.

"This is the latest in a series of troubling reports of possible adverse effects of SSRIs on the fetus," Dr. James L. Mills of the National Institute of Child Health and Human Development wrote in an accompanying editorial.

Other research has linked use of the antidepressants late in pregnancy to jitteriness, irritability, low blood sugar and difficulty breathing in newborns. The Food and Drug Administration warned last year that Paxil may be associated with heart defects when taken during the first three months of pregnancy.

For ethical reasons, medications cannot be tested on pregnant women, and the possible effects of a drug on a fetus can only be observed after the medicine is on the market and in use.

One of the researchers, Christina Chambers of the University of California at San Diego, said of the findings, "If it's a true risk, it's very low." According to the researchers' calculations, 99 percent of women who took the antidepressants late in pregnancy would deliver a child without the problem.

Dr. Sandra Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, called the results worrisome and said the agency would be issuing a public health advisory in a few days.

"I would emphasize that this isn't a cause for panic among women who are taking these medications," Kweder said.

Women should not stop taking the antidepressants on their own and should check with their doctors if they have concerns, Kweder said. "For many women, the small risk suggested by this study may be outweighed by their own personal need for treatment of a mental health condition," she said.

In the study, researchers looked at a problem called persistent pulmonary hypertension. The disorder develops after birth when the infant's lungs do not quickly adapt and there is not enough oxygen reaching the blood. It occurs in one or two infants per 1,000 births.

The researchers interviewed the mothers of 377 infants who had the problem and asked them if they had taken any medication for depression while pregnant. The women were compared with the mothers of 836 healthy babies born about the same time.

Fourteen mothers whose infants had the complication reported taking SSRIs during the second half of their pregnancy, compared with six mothers in the comparison group. The researchers calculated the antidepressants increased the risk of the disorder six-fold.

They found no increased risk of the lung problem from SSRI use during the first half of pregnancy or from the use of other antidepressants during pregnancy.

Chambers and some of the other researchers have received research support from drug makers.

Analysis: SSRIs' risk to infants

Mon, 06 Feb 2006 00:00:00 -0800

The class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) is facing more bad news this week with the release of a study indicating that pregnant women's use of the drugs may be dangerous to their newborn infants.

The study, which appears in the February issue of Archives of Pediatrics and Adolescent Medicine, found that nearly one-third of newborn infants whose mothers took SSRIs during pregnancy experienced withdrawal symptoms that included high-pitched crying, tremors and disturbed sleep.

Natalie Taylor, an analyst with Decision Resources, said the finding could affect the SSRI market but noted that the field is already leveling off due to another danger previously linked to the drug class, an increased risk of suicidal behavior and thoughts in children and adolescents.

The suicidal risk, first publicized in late 2004, prompted the Food and Drug Administration to add a black-box warning to top-selling SSRIs like GlaxoSmithKline's Paxil and Pfizer's Zoloft.

Aside from the bold new warnings on SSRI labels, Taylor added, many of the medications have gone off patent or will soon.

"This might have an impact, but I think in any case the bottom line is that you need to weigh the benefits with the risks," she told United Press International.

The symptoms of major depression are severe enough that it may warrant putting a pregnant woman on an SSRI even if that does increase the risk of withdrawal symptoms in her infant, Taylor said. But if the patient has a milder case of depression, it might be worth reconsidering whether to put her on the medications, she said.

Overall, "the market (of SSRIs) is plateauing," Taylor said.

In the study, a team of researchers led by Gil Klinger of Tel Aviv University assessed withdrawal symptoms in 60 newborn infants who had prolonged exposure in the womb to SSRIs, including GlaxoSmithKline's Paxil, Lilly's Prozac, Forest's Celexa, Pfizer's Zoloft and Wyeth's Effexor.

Eighteen of the infants had symptoms of withdrawal, including eight with severe symptoms and 10 with milder symptoms.

"The high prevalence of neonatal abstinence syndrome in infants exposed to SSRIs in utero should be brought to the attention of family physicians, psychiatrists, gynecologists, pediatricians and mothers," Klinger and colleagues wrote in the journal.

"Because maternal depression during pregnancy also entails a risk to the newborn, the risk-benefit ratio of continuing SSRI treatment should be assessed," the researchers said.

They also recommended that infants of mothers taking SSRIs should be monitored closely after birth for a minimum of 48 hours and that "follow-up of exposed infants, particularly those who develop severe symptoms, is needed to assess the long-term effects of prolonged exposure to SSRIs."

Neonatal safety is an issue that apparently neither the FDA nor most SSRI manufacturers want to discuss. UPI contacted the FDA and several manufacturers, including Forest Laboratories, Pfizer and GlaxoSmithKline, but only Eli Lilly, which makes Prozac, responded.

"Lilly does not and has never promoted the use of Prozac in pregnant or nursing mothers," Lilly spokeswoman Heather Lusk told UPI.

Nevertheless, Lusk said, "Decisions regarding the use of anti-depressants during pregnancy should be made after considering an appropriate benefit-risk assessment by the attending physician. Absent such a determination, conclusions resulting in discontinuation of Prozac or any other anti-depressant treatment may result in serious health consequences from untreated maternal depression."

SSRIs came under fire in 2004 when British researchers obtained unpublished studies from manufacturers and concluded the medications (except for Prozac) appeared to increase the risk of suicide and suicide attempts in children.

The FDA is currently reviewing studies to determine if the same risk is present in adults. The agency said last July that it could take more than a year to complete its review.

WARNING: Withdrawal Reactions With Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants

Thu, 01 Dec 2005 00:00:00 -0800

A withdrawal reaction has been reported with all SSRI antidepressants: citalopram (CELEXA); escitalopram (LEXAPRO), fluoxetine (PROZAC, SARAFEM); fluvoxamine (LUVOX); paroxetine (PAXIL); and sertraline (ZOLOFT).

The symptoms generally start within one to three days after stopping the drug and generally resolve within one to two weeks after the drug has been discontinued. Withdrawal symptoms may occur even when the dosage of the drug is gradually decreased. The main symptoms of this reaction are dizziness, vertigo, incoordination, nausea and vomiting, and flulike symptoms that include fatigue, lethargy, muscle pain, and chills.

Healthcare professionals were notified on Sept. 27, 2005 that the professional product labeling for the selective serotonin reuptake inhibitor (SSRI) antidepressant paroxetine (PAXIL, PAXIL CR) was being updated to warn of major congenital malformations (birth defects), primarily heart malformations, in children born to women taking the drug during their first trimester of pregnancy.

Paroxetine was first marketed in the U.S. in December 1992 and last year, sales of the drug exceeded $824 million. Paroxetine is produced by GlaxoSmithKline of Research Triangle Park, NC.

The warning was based on a study that the FDA had asked GlaxoSmithKline to conduct. The study used two insurance company databases that store medical and pharmacy claims from health plans throughout the U.S. All women dispensed an antidepressant and who had delivered a live child between May 2000 and June 2003 were identified for the analysis.

The study suggested an over two-fold increase in the risk of major congenital malformations when paroxetine was taken compared to other antidepressants. This type of statistical research is not considered as reliable as a randomized “gold standard” study, which might support a conclusion that paroxetine causes birth defects. But it is more than sufficient to warn women of the possibility.

A more complete description of this study can be found on GlaxoSmithKline’s Web site at: http://ctr.gsk.co.uk/Summary/ paroxetine/epip083.pdf.

SENATE MAJORITY LEADER URGES DRUG INDUSTRY TO STOP DIRECT-TO-CONSUMER ADVERTISING (DTCA) FOR THE FIRST TWO YEARS A NEW DRUG IS ON THE MARKET

Sat, 02 Jul 2005 00:00:00 -0700

Lawmakers as well as the American Medical Association (AMA) are finding it more and more difficult to ignore the escalating problems associated with DTCA.

The American Medical Association (AMA) considered the issue and, although several proposals that called for the AMA to support a ban on DTCA were rejected by the AMA’s policy making House of Delegates, the issue was sent to the Association’s Council on Science with a directive to deliver a detailed report on the subject at the next AMA meeting in December.

Earlier this year, Senators Charles Grassley (R., Iowa) and Christopher Dodd (D., Conn.) proposed a new FDA board, which would have as one of its functions, evaluating DTCA before it is released to the market.

Now, Senate Majority Leader Bill Frist has openly requested pharmaceutical companies to stop DTCA for the first two years a new drug on the market. The industry is aware it must make serious changes in its advertising approach; however, so drastic a unilateral move on its part is unlikely.

There is little doubt that prescription drug marketing tactics are under close scrutiny at this time. No aspect of marketing strategy is more controversial than DTCA.

While some experts maintain that DTCA actually strengthens our health care system, others are equally certain that DTCA has caused many of the problems that plague the drug industry (over-medicating, over-pricing, and exaggerated and often misleading advertising claims). There are even those who strongly urge that DTCA “must be banned as part of FDA reform.” (http://www.newstarget.com/z003204.html)

A growing number of doctors and other healthcare professionals believe that any perceived benefits from DTCA are far outweighed by the problems it has caused and the burden it has placed on the FDA to regulate the content and accuracy of thousands of TV, radio, print, and online advertisements. The FDA Division of Drug Marketing, Advertising and Communications has about three dozen employees to review 30,000 to 40,000 DTC ads each year.

Today, drug advertising has become an industry unto itself and inadequately tested and hastily marketed drugs permeate the market and expose the public to great risk.

In 1989 DTCA spending totaled $12 million. By 1992 that figure had jumped to $156 million. When TV and radio ads were added to the mix, spending began to take off, reaching $844 million in 1997 and $1.58 billion in 1999. The figure then soared to $2.38 billion in 2001 and is now in the vicinity of $3.8 to 4 billion.

All of this spending is not without reward, however. A recent study by researchers at Harvard University and the Massachusetts Institute of Technology analyzed the effect of DTCA advertising on consumer spending for prescription drugs. The study found that a 10% increase in advertising of drugs within a therapeutic drug class resulted in a 1% increase in sales of he drugs in that class.

When these findings were applied to the 25 largest drug classes in 2000, it was found that every $1.00 spent on DTCA yielded $4.20 in drug sales. DTCA was thus responsible for 12% of the increase in prescription drug sales or an additional $2.6 billion in 2000 alone.

Another study conducted (between 1999 and 2000) by the National Institute for Health Care Management (NIHCM) found that DTCA resulted in significant increases in retail spending.

The study found that the 50 most heavily advertised drugs were responsible for 47.8% of the increase in retail spending on prescription drugs between 1999 and 2000 (some $9.95 billion) while increases in sales of some 9,850 other drugs on the retail market accounted for 52.2% of the one-year rise in retail pharmaceutical spending (about $10.86 billion).

In a perfect world, the benefits of DTCA touted by some experts would be quite understandable and even warranted. Many experts see the serious problems plaguing the system as making any such praise undeserved. Some of those problems include:

•   Repeated findings by the FDA that many ads are deceptive, inaccurate, misleading, and otherwise in violation of federal law.

•   The FDA is forced to expend an ever-increasing portion of its budget and manpower on policing advertising instead of more carefully investigating new drug applications and adverse reaction reports.

•   DTCA takes valuable assets away from research and development.
•   DTCA drives up the retail price of drugs.
•   DTCA results in over medicating the public.
•   DTCA results in expensive drugs being taken by patients who would be better off taking safer and cheaper alternatives already on the market.
•   DTCA leads people taking drugs they do not need in the first place.
•   DTCA eliminates the “learned intermediary” (physician) from the decision making process in many cases and, in others, doctors are placed in the awkward position of having to prescribe a drug or lose a patient.
•   DTCA uses celebrities, athletes, and even retired news anchors (who have no medical or pharmaceutical training) to vouch for the safety and effectiveness of prescription drugs.

•   DTCA uses music which is (or was) popular with the target audience in order to subconsciously influence choice.
•   Warnings are confined to extremely small type at the bottom of the page or TV screen and rapidly spoken segments of commercials.

•   DTCA capitalizes on the widely held but erroneous belief among consumers that “newer is better.”
•   DTCA ultimately places marketing above science.

The FDA often issues stern warnings to drug companies about misleading or deceptive statements or unproven claims of superiority. These warnings, however, are usually not made public. In fact, they are even sometimes ignored by the offending company or not acted upon for months or years.

Recently, pharmaceutical giants such as Merck, Pfizer, Bayer, and GlaxoSmithKline have received warning letters from the FDA regarding the use of false or misleading advertisements and promotional materials.

Merck, the manufacturer of Vioxx, the Cox-2 inhibitor that was pulled from the market in September of 2004, was warned as far back as September 2001 that their promotional activities and materials were “false” and “lacking in fair balance.”

In addition, Merck’s promotional campaign minimized the now-known serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study.

Pfizer also received a warning letter (January 2005) identifying five promotional pieces for the Cox-2 inhibitors Bextra and Celebrex which, according to the FDA’s letter: “omit material facts, including the indication and risk information; fail to make adequate provision for the dissemination of the FDA-approved product labeling; and make misleading safety, unsubstantiated superiority, and unsubstantiated effectiveness claims.”

The FDA claimed that the ads in question, such as the one featuring a woman playing the long version of a song on the guitar and a 27-minute long infomercial featuring “regular people” talking about their arthritis pain, are misleading because of their overstatement of effectiveness as well as the omission of risk information.

GlaxoSmithKline was likewise warned about misleading advertisements for its hypertension drug called Coreg.

In April, the FDA ordered Bayer and GlaxoSmithKline to withdraw certain commercials for the erectile dysfunction drug, Levitra. The FDA found the 15-second ad did not state possible side effects, did not prove its claim of superiority over competing drugs, and could not substantiate the claim that it gives female partners greater sexual satisfaction.

As recently as November 2004, Pfizer was ordered to pull an ad for Viagra off the air for similar reasons. Thus, it was not as if the drug industry had not been warned of this improper advertising approach with respect to the very same class of drugs.

On May 6, in a strongly worded letter, the FDA advised pharmaceutical giant Pfizer Inc., that one of its direct-to-consumer (DTC) print advertisements for the powerful anti-depressant psychotropic drug Zoloft “is false or misleading because it omits important information relating to the risk of suicidality in patients taking Zoloft, in violation of the Federal Food, Drug, and Cosmetic Act…and implementing regulations…This ad is concerning from a public health perspective because it fails to include a serious risk associated with the drug.”
The letter as well as a warning to health care professionals was also posted on the FDA’s website. The FDA has also issued an alert concerning Zoloft and the risk of pediatric suicide.
Thus, rather than demonstrate a full commitment to truthful advertising, pharmaceutical companies are often caught attempting to mislead the public.

This untrustworthiness forces the FDA to divert valuable resources (money and manpower) from investigating new drug applications and adverse events related to existing drugs.

DTCA has been blamed for COX-2 inhibitors like Vioxx, Celebrex, and Bextra being greatly over-prescribed for years especially to patients who never needed them in the first place.

Over-medicating is a very serious problem and it is occurring more and more frequently with respect to the most advertised drugs such as those for pain, high cholesterol, gastrointestinal disorders, depression, and disorders that cause embarrassment (incontinence, herpes, yeast and fungal infections, and erectile dysfunction).

In addition, the fact that COX-2 inhibitors cost between 10 and 15 times more than cheaper, safer, and equally effective painkillers such as naproxen, ibuprofen, and aspirin was never conveyed in any of the DTCA. This is a common occurrence in DTCA of designer drugs and one that greatly increases the cost of healthcare.

Of course as healthcare expenditures rise, so does the cost of health insurance and government programs that subsidize health benefits to senior citizens and those of limited means.

While many DTC advertisements feature unknown actors or voiceovers, a significant number of ads rely upon celebrities, athletes, and famous musical recordings to entice the public. Prominent broadcast journalists such as Walter Cronkite and Aaron Brown were used to blur the line between journalism and advertising. Critics argue that this kind of DTCA misleads viewers by “packaging promotional material to look like news.”

Although one would like to believe that a doctor will only be guided by his medical training when deciding whether to prescribe a drug, that is not always the case. Doctors are often faced with patients who literally demand to be given a certain drug based on nothing more than a slick TV ad. Surveys have shown, however, that doctors too can be prone to believing that “newer is better.”

A study published in the April 27 issue of the Journal of the American Medical Association used 18 actors pretending to be patients to make 300 visits to 152 doctors’ offices with fake psychological symptoms. The actors also mentioned seeing the ad for the antidepressant Paxil.

When complaints of stress and fatigue were mentioned, the actors were five times more likely to be given a prescription when they mentioned the Paxil ad. Most of the actors who did not complain of depression were not given prescriptions, but when they specifically asked for Paxil, 55% were given prescriptions and 50% received a diagnosis of depression.

The important thing is to determine, with the help of a physician and truthful information from the drug companies, what the correct medical decision is for the patient. Consumers should not be making these decisions. Unfortunately, this is exactly what DTCA seeks to do as one of its goals.

Dr. Frist firmly believes, as do most experts on the subject, that skyrocketing advertising costs have encouraged “inappropriate prescribing” and higher drug prices. As a result, he has asked the Government Accountability Office to investigate the FDA’s supervision of DTCA, the level of spending for DTCA, and the effects of DTCA on patient awareness, education, and other matters.

FDA Warns About Antidepressants, Suicide

Fri, 01 Jul 2005 00:00:00 -0700

The Food and Drug Administration issued a second public warning Friday that adults who use antidepressants should be closely monitored for warning signs of suicide, especially when they first start the pills or change a dose.

Much of the concern over suicide and antidepressants has centered on children who use the drugs. The FDA last fall determined there is a real, but small, increase in risk of suicidal behavior for children and ordered the labels of all antidepressants to say so.

A year ago, the FDA issued a warning that adults, too, may be at increased risk. The agency began reanalyzing hundreds of studies of the drugs to try to determine if that's the case, and told makers to add or strengthen suicide-related warnings on their labels in the meantime.

Since then, several new studies have been published in medical journals about a possible connection. Citing them, FDA issued a new public health advisory reminding doctors and patients to watch closely for suicidal thinking or worsening depression and seek medical care if it happens.

It's a difficult issue to sort out because depression itself can lead to suicide and studies show that antidepressants have helped many people recover.

But there are concerns that antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects. Also, psychiatrists say there is a window period of risk just after pill use begins, before depression is really alleviated but when some patients experience more energy, perhaps enabling them to act on suicidal tendencies.

In addition to the advisory, the FDA also updated its Web site with a notice about a higher-than-expected rate of suicide attempts in research with the nation's newest antidepressant, Eli Lilly's Cymbalta. Those studies were in women trying Cymbalta as an incontinence treatment; it was never approved for that use. The FDA insisted when it approved Cymbalta last year that studies of depressed patients showed no suicide link.

FDA Tells Manufacturer to Halt Use of Direct-to-Consumer Ad

Fri, 03 Jun 2005 00:00:00 -0700

An ad for a popular antidepressant starring a seemingly depressed cartoon character runs afoul of the FDA since it omits required warnings about suicidality risk.

The U.S. Food and Drug Administration (FDA) has told Pfizer Pharmaceuticals to cease distribution immediately of a direct-to-consumer advertisement for the company's serotonin reuptake inhibitor antidepressant, sertraline (Zoloft), because it does not carry the proper warning information.

In a May 6 letter, officials in the FDA's Division of Drug Marketing, Advertising, and Communications targeted a print ad for Zoloft that ran in the New York Times on October 24, 2004. That ad, the FDA said, "is false or misleading because it omits important information relating to the risk of suicidality in patients taking Zoloft, in violation of [federal law and] FDA regulations. This ad is concerning from a public health perspective because it fails to include a serious risk associated with the drug."

The Zoloft ad features an apparently depressed-looking animated character with sad eyes and frowning mouth. The caption reads, "If this is how you feel, this is what could help," referring to a CD-ROM in a Zoloft case. The consumer is then invited to call a toll-free number or visit a Web site to "get a free info kit with CD-ROM."

The ad includes appropriate notation, required by FDA regulations, telling consumers exactly what the product has been approved to treatin this case, depression in those aged 18 or older. The ad also includes the sentence, "Side effects may include dry mouth, insomnia, sexual side effects, diarrhea, nausea, and sleepiness." The ad goes on to say, "In studies, few people were bothered enough by side effects to stop taking Zoloft."

The problem, according to the FDA, is that the Zoloft ad contains information from an outdated package insert (PI). "The brief summary page of the ad," the FDA noted, "is excerpted from an outdated September 2003 PI, rather than the most current version of the PI as of the time the ad was run"

Last fall the Zoloft PI was changed to include a warning that "patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases."

The revised label also includes a reminder that families and caregivers of patients taking the medication should be alerted to look for emergence of "agitation, irritability, and other symptoms," as well as "the emergence of suicidality, and to report such symptoms immediately to health care providers."

The FDA told Pfizer to stop using the ad or promotional materials similar to it and to submit a written response to the agency describing the company's "intent to comply with this request."

Pfizer did not respond to requests by Psychiatric News for comment.

The warning letter comes at a time when the FDA is stepping up enforcement actions on product marketing, especially regarding direct-to-consumer (DTC) advertising. The agency is also aiming to make DTC ads more easily understandable and straightforward.

In April Thomas W. Abrams, R.Ph., director of the FDA's Division of Drug Marketing and Communications, told a meeting of pharmaceutical company medical liaisons, "Consumers ignore the presentation of adverse effects in print advertisements and TV commercials. We have got to get people to pay attention, and one way to do that is to have headlines and a question-and-answer format so that it is more appealing."

That approach is already being piloted in television ads for certain products, such as birth-control pills.

"We have to ensure that the complete picture of a drug is conveyed and get more useful information about drugs and diseases to the American public," Abrams said.

FDA Issues Warning to Pfizer Regarding Zoloft Ad

Mon, 23 May 2005 00:00:00 -0700

In a strongly worded letter, the FDA advised pharmaceutical giant Pfizer Inc., that one of its direct-to-consumer (DTC) print advertisements for the powerful anti-depressant psychotropic drug Zoloft "is false or misleading because it omits important information relating to the risk of suicidality in patients taking Zoloft, in violation of the Federal Food, Drug, and Cosmetic Actand implementing regulationsThis ad is concerning from a public health perspective because it fails to include a serious risk associated with the drug."

The letter as well as a warning to health care professionals was also posted on the FDAs website. The FDA has also issued an alert concerning Zoloft and the risk of pediatric suicide.

FDA Warns Pfizer About Zoloft Magazine Ad

Mon, 09 May 2005 00:00:00 -0700

A magazine advertisement for the antidepressant Zoloft omitted important information about the possibility of suicide, The Food and Drug Administration said in a May 6 letter to the drug's manufacturer, Pfizer Inc.

The letter, along with a warning to health care professionals about possible suicide risk with Zoloft, was posted on the FDA's Web site Friday. The Wall Street Journal reports that the ad the government agency mentioned was one that ran in the New York Times Sunday Magazine Oct. 24, 2004. The FDA letter reminded Pfizer it had alerted the pharmaceutical company in May 2004 that the information had to be included the labeling material on all print advertising.

"This ad is concerning from a public health perspective because it fails to include a serious risk associated with the drug," the FDA Consumer Promotion Analyst Kay A. Chitale wrote. She told Pfizer to immediately stop using that particular ad or similar ones. "Specifically, the main page of the ad fails to communicate any information pertaining to the risk of clinical worsening and suicidality in patients who are on Zoloft therapy," Chitale concluded.

The Wall Street Journal said that the Pfizer had agreed to change the Zoloft label last July. The pharmaceutical company didn't return a phone call from the newspaper asking for comment, the Journal said.

Whether deliberately or by coincidence, the FDA issued the alert about Zoloft and the risk of pediatric suicide (www.fda.gov ) to the public and health officials on May 5.

Study Ties Antidepressants To Suicide

Mon, 21 Feb 2005 00:00:00 -0800

Adults taking popular antidepressants such as Prozac, Paxil and Zoloft are more than twice as likely to attempt suicide as patients given placebos, according to an analysis of hundreds of clinical trials involving tens of thousands of patients.

The results, published last week in the British Medical Journal, mirror a recent finding of the Food and Drug Administration that the drugs increase suicidal thoughts and behavior among some children and offer support to concerns going back 15 years that the mood-lifting pills have a dark side.

The examination of 702 controlled clinical trials involving 87,650 patients is the most comprehensive look at the subject and is particularly telling because it counted suicide attempts and included patients treated for a variety of conditions, including sexual dysfunction, bulimia, panic disorder and depression.

Experts cautioned, however, that the risks should be balanced against the drugs' benefits. They have been shown to be effective against depression and a host of other disorders in adults, a positive track record largely missing in tests of the drugs on children.

The new study is certain to add to the controversy over the class of drugs known as selective serotonin reuptake inhibitors, or SSRI's.

Since the arrival of Prozac in 1988, these drugs have transformed psychiatry in the United States, even as persistent critics have warned that their benefits were hyped and their risks ignored. A spate of lawsuits in recent years have claimed that the drugs were responsible for violent and suicidal behavior.

New analyses of clinical trials in children last year prompted the FDA to require a prominent black box warning on labels, saying that the medications could increase the risk of suicide. The warning refers only to children but is given to all patients.

American psychiatrists continue to strongly back SSRI drugs. Groups such as the American Psychiatric Association say that fears of drug-induced suicide are vastly exaggerated and that untreated depression carries a far greater risk of suicide.

FDA officials have said they are conducting an independent analysis.

Drugs Raise Risk of Suicide

Fri, 18 Feb 2005 00:00:00 -0800

Adults taking popular antidepressants such as Prozac, Paxil and Zoloft are more than twice as likely to attempt suicide as patients given sugar pills, according to an analysis released yesterday of hundreds of clinical trials involving tens of thousands of patients.

The results mirror a recent finding of the Food and Drug Administration that the drugs increase suicidal thoughts and behavior among some children, and offer tangible support to concerns going back 15 years that the mood-lifting pills have a dark side.

The examination of 702 controlled clinical trials involving 87,650 patients is the most comprehensive look at the subject and is particularly telling because it counted suicide attempts and included patients treated for a variety of conditions, including sexual dysfunction, bulimia, panic disorder and depression.

Experts cautioned, however, that the risks should be balanced against the drugs' benefits. They have been shown to be effective against depression and a host of other disorders in adults, a positive track record largely missing in tests of the drugs on children.

Adults with severe depression should continue to be considered for drug treatment, but those with milder symptoms should probably not be medicated, said John Geddes, a professor of epidemiological psychiatry at Oxford University, who wrote a commentary accompanying the studies.

"For a lot of time, these drugs were seen as a panacea for low mood in general," he said in a telephone interview. "We do need to ensure they are only prescribed for patients with clearly diagnosed depressive disorders."

The new study is certain to add to the controversy over the class of drugs known as selective serotonin reuptake inhibitors, or SSRI's. After the arrival of Prozac in 1988, these drugs have transformed psychiatry in the United States, even as persistent critics have warned that their benefits were hyped and their risks ignored. A spate of lawsuits in recent years have claimed that the drugs were responsible for violent and suicidal behavior.

New analyses of clinical trials in children last year prompted FDA to require a prominent black-box warning on labels that the medications could increase the risk of suicide. The warning refers only to children but is given to all patients.

American psychiatrists continue to strongly back SSRI drugs. Groups such as the American Psychiatric Association say that fears of drug-induced suicide are vastly exaggerated and that untreated depression carries a far greater risk of suicide.

"If these medications were really increasing the incidence of suicide attempts, you would think we would be seeing more completed suicides," said David Fassler, an APA trustee and psychiatrist in Burlington, Vt. "In fact, we are seeing exactly the opposite."

Adolescent suicide rates have dropped 25 percent since the early 1990s, even as more than a million children were put on the drugs, Fassler said. Although no one can say for sure what the connection is between those two trends, Fassler said, "if the medications were significantly increasing the risk of suicide, it is unlikely we would be seeing this kind of decline over time."

The new analysis seems likely to deepen transatlantic divisions over how the drugs are perceived and prescribed: British authorities last year recommended that depressed patients who were able function at home and work should not be medicated right away, but should be counseled to try exercise, self-help, talk therapy or watchful waiting.

David Healy, a psychiatrist at the University of Wales who helped conduct the new study, said managed-care insurance companies in the United States were not likely to look kindly upon physicians who monitor patients without prescribing drugs.

Healy prescribes the drugs but has long raised red flags about them. He asked yesterday why scientists at the FDA and research universities had not previously conducted this analysis, given that the data have long been available.

"For whatever reason, an awful lot of people didn't want to think there was a risk," he said.

FDA officials have said they are conducting an independent analysis.

The new study was conducted by epidemiologist Dean Fergusson and his colleagues at the Ottawa Health Research Institute and included scientists from McGill University. It is published in the current issue of the British Medical Journal along with two related articles and a commentary by Geddes and University of Verona psychiatrists Andrea Cipriani and Corrado Barbui.

Scientists have long bemoaned the lack of high-quality studies on antidepressants and the risk of suicide. One of the new studies, by University of Bristol and University of London researchers, examined drug trials submitted by pharmaceutical companies to British regulators. It found some evidence of self-harm among patients taking antidepressants but was inconclusive as to whether the drugs increased the risk of completed suicides.

A third study found no difference in suicide risk between SSRI drugs and an earlier class of medications known as tricyclic antidepressants.

Complicating the picture is the fact that suicide is rare meaning that it takes very large studies to yield definitive results. Fergusson's meta-analysis pooled data from a large number of studies in the same manner as the recent FDA analysis involving children's trials.

The American Psychiatric Association's Fassler said such an approach could miscount the number of attempted suicides. He said depressed patients who were getting better as a result of medication might be more likely to tell doctors about a suicide attempt, thereby muddying the data.

While Fergusson agreed that better trials are needed, he said he was confident about the results of this analysis, because it relied on placebo-controlled trials considered the most definitive. And not all the patients getting drugs were being treated for depression, he said there was evidence of increased risk of suicide attempts for patients with all kinds of disorders.

Suicide "is uncommon but serious," Fergusson said in an interview. "The biggest concern is these drugs are widely prescribed. There are millions of people on the drugs, so even a risk of one in a 1,000 when you amplify it to the millions, it becomes a public health issue."

FDA Approves Antidepressant Warning Language

Fri, 14 Jan 2005 00:00:00 -0800

In a long-awaited move, the Food and Drug Administration has approved the language for so-called black-box warnings on antidepressants, an agency spokeswoman said late yesterday.

The action comes four months after a government panel determined the medicines were linked to suicide in youngsters. As a result, the panel recommended drug makers add the warnings in order to alert doctors to the serious side effects.

The recommendation followed 18 months of controversy over the medicines. The episode cast a harsh spotlight on the pharmaceutical industry after it became known that some drug makers failed to disclose links between their antidepressants and suicide.

A black-box warning is the most severe warning that can be issued about a prescription drug. The information is prominently placed on package inserts and in physician reference manuals that are read by doctors nationwide.

The warning will be added to several widely prescribed drugs, including Effexor, Zoloft, Paxil and Prozac. Only Prozac was approved for children, but doctors are free to prescribe any medication for patients, which explained widespread usage of many pills.

In a letter to drug makers, the FDA wrote that final labeling should be on company Web sites within two weeks and on all products within 30 days, according to the Pink Sheet, an industry publication. A medication guide is also supposed to be available by Jan. 31.

Doug Petkus, a spokesman for Wyeth, said the Madison-based drug maker, which sells Effexor, will "move as quickly as possible" to add the black-box warnings, although he couldn't provide a specific date.

Last month, some consumer advocates began complaining the FDA was taking too long to enforce the labeling change. They worried some doctors may not change prescribing habits until warnings were issued.

FDA officials said the lengthy process was not unusual, given the need for time-consuming reviews and discussions between agency officials and drug makers. Last month, they said the black-box warning should be in place by late January.

But yesterday, one advocate said the black-box warning was long overdue and continued to criticize the FDA for not acting sooner.

"It shouldn't take this long to issue a warning involving children," Vera Sharav of the Alliance of Human Research Protection said.

Dad Cites Boy's Antidepressants in Deaths

Sun, 05 Dec 2004 00:00:00 -0800

Authorities say three years ago, Christopher Pittman, then 12, shot his grandparents as they slept because they had scolded him for fighting. But Christopher's father, Joe Pittman, thinks his son killed because his sense of right and wrong was clouded by the anti-depressant Zoloft.

Joe Pittman spoke out against the drug in a Food and Drug Administration hearing early this year. The boy, who had threatened suicide, was put on the drug three weeks before the slayings, and his dose was doubled just two days earlier.

Joe Pittman's hands shook as he read his son's confession to a roomful of strangers during the hearing.

"I took everything out on my grandparents, who I loved so very much," wrote then-12-year-old Christopher Pittman. "When I was lying in my bed that night, I couldn't sleep because my voice in my head kept echoing through my mind, telling me to kill them."

But prosecutors and police say Christopher's actions during and after the November 2001 slayings show he clearly knew what he was doing was wrong.

The boy waited until his grandparents were sleeping and took a pump-action shotgun from a gun cabinet. He crept into the couple's dark bedroom, first shooting 66-year-old Joe Frank Pittman in his open mouth, then firing into the back of 62-year-old Joy Pittman's head.

Christopher then set the house on fire and drove off in the family car. When he got stuck on a dirt road 20 miles away, he told hunters he was kidnapped by a man who killed his grandparents, set the fire, drove him into the woods and ran away.

Christopher was living with his father's parents in hopes of turning his life around. He told defense experts he felt abandoned by his mother and his relationship with his father was rocky. No one answered phone calls to Joe Pittman's home.

A month before the slayings, Christopher was hospitalized in Florida, where his father lives, after he threatened to kill himself. The boy was prescribed the anti-depressant Paxil, but another doctor soon put him on Zoloft instead.

Pittman decided to send the boy to live with his grandparents in Chester County, a rural area between Columbia and Charlotte, N.C.

Christopher, who turns 16 in April, is being prosecuted as an adult and faces 30 years to life in prison if convicted at his trial, set to start next month. His lawyers argue that his case should be moved to Family Court, where if convicted, he could only be kept in custody until he turns 21.

In the three years the teen has spent in jail awaiting trial, the FDA has become increasingly wary of doctors prescribing Zoloft and other antidepressants for children.

In October, the agency ordered the drugs to carry "black box" warnings the government's strongest warning short of a ban about increasing the risk of suicidal behavior in children.

"The science has been out there for a while. The prescription drug companies have been able to hide it," Menzies said.

On the other side is Pfizer Inc., the maker of Zoloft, which has aided the prosecution, according to Solicitor John Justice, who has since taken himself off the case for health reasons.

The company has vigorously fought cases claiming antidepressants cause violent or suicidal behavior.

A spokesman responded to inquiries by pointing out an October statement on the company's Web site addressing concerns of suicide attempts, saying studies show "no statistically significant difference" between children using Zoloft and nonusers. The statement, though, does not discuss any possible link between the drug and violent acts against others.

Trying to blame a drug for causing someone to commit a crime is an uphill fight, but it has been done successfully.

In April, a Santa Cruz, Calif., jury acquitted a man of attempted murder after he beat his friend, then blamed the episode on Zoloft.

National Association of Criminal Defense Lawyers spokesman Jack King said the "Zoloft-made-me-do-it" defense likely means that the Pittman case will come down to defense vs. prosecution experts.

"It's going to be a battle of whose experts the jury believes," King said.

Christopher's maternal grandmother, Delnora Duprey, of Wildwood, Fla., said her grandson is no longer on any medication and is the "sweet, quiet, laid-back" boy she knew growing up. "He's the old Christopher again."

Duprey says the "whole entire family is behind Christopher 150 percent."

"We used to joke that he was his Pop-Pop's shadow," Duprey said.

However, those who dealt with the boy after the crime feel differently.

"Anybody who could kill his grandparents in the fashion he did shouldn't be let loose on the public at age 21. And that would have been the best-case scenario," said former prosecutor Justice, who pushed to move the case to adult court.

The current prosecutor, Barney Giese of Columbia, said through his office that he doesn't talk about cases before they go to trial.

Chester County Sheriff Robbie Benson said interviews with Christopher left him shaken because he could not believe the lack of remorse. "This was cold-blooded."

"The boy was still suffering from the side-effects of this medication after the incident," she said. "I think we see a different Christopher now."

Lawsuit Blames Zoloft for Teenager's Suicide

Thu, 28 Oct 2004 00:00:00 -0700

A South Jordan couple on Tuesday accused pharmaceutical giant Pfizer Inc. of negligence in their daughter's "tragic, maddening, wrongful death" for allegedly failing to warn doctors of a link between its antidepressant Zoloft and teenage suicide.

In a suit filed in U.S. District Court, the parents of Shyra Marie Kallas say the 15-year-old shot herself in November 2002, less than a month after her family physician prescribed the antidepressant.

The girl originally went to see the doctor for warts but said, as part of her patient history, that she felt overwhelmed with school work, according to Ken and Angela Kallas' suit.

"Her doctor then did precisely what Pfizer's salesmen regularly encourage doctors to do, i.e., he (a) diagnosed 'depression' and (b) prescribed Zoloft," claims the suit, which seeks unspecified damages.

The legal action alleges Pfizer knew of an association between Zoloft and side effects that increase the risk for suicide. However, it claims, the company continued to overpromote the medication and misled the public about the risk, touting Zoloft as the "number one doctor-trusted antidepressant."

Pfizer representatives could not be reached for comment Tuesday. In its 2004 third-quarter performance report released last week, the New York City-based company said, "Zoloft is not approved for pediatric depression. In fact, there have been no suicides in the Zoloft pediatric clinical program.

"Pfizer remains confident in the proven safety and efficacy of Zoloft to treat millions of patients with mood and anxiety disorders."

In an Oct. 15 advisory, the Food and Drug Administration said all antidepressants will now carry labels that include a boxed warning about the increased risk of suicide they pose to children and adolescents.

FDA Orders Strong Antidepressant Warnings

Fri, 15 Oct 2004 00:00:00 -0700

All antidepressants must carry a "black box" warning, the government's strongest safety alert, linking the drugs to increased suicidal thoughts and behavior among children and teens taking them, the Food and Drug Administration said Friday.

Because the warnings are primarily seen by doctors, the agency also is creating an information guide for patients to advise them of the risk.

"Today's actions represent FDA's conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them," said Dr. Lester Crawford, acting FDA commissioner.

The drug labels also include details of pediatric studies which, thus far, have pointed to Prozac as the safest antidepressant for youths to take.

On average, 2 percent to 3 percent of children taking antidepressants have increased suicidal thoughts, independent experts, working with Columbia University, found.

The FDA announcement follows to the letter guidance from federal advisers. After searing and emotional public hearings one month ago, the advisers urged the agency to add its most strident warnings to the drugs.

The FDA said in a statement that it recognizes that depression in pediatric patients "can have significant consequences in pediatric patients if not appropriately treated. The new warning language recognizes this need but advises close monitoring of patients as a way of managing the risk of suicidality."

An information guide will be distributed with each antidepressant prescription. Parents will be advised to look for warning signs in children that include worsening depression, agitation, irritability, and unusual changes in behavior. Those worrisome signs could come within the first months of starting an antidepressant or when the drug's doses changes higher or lower.

In 24 trials involving more than 4,400 patients taking antidepressants, researchers found a greater risk of increased suicidal thoughts and behavior during the first few months of treatment.

Celexa, Prozac and Zoloft posed lower risks for children, researchers found, while Luvox, Effexor and Paxil had higher risks of increased suicidal thoughts and behavior.

Prozac is the only antidepressant approved by the FDA for use for treating depression in pediatric patients.

Anafranil, Prozac, Luvox and Zoloft have been used for treating obsessive compulsive disorder in pediatric patients.

The new warnings, however, will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Limbitrol, Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax,Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.

The agency's action comes at a time when it faces withering criticism for not acting sooner on antidepressants, and for the shortage of flu vaccine and the high-profile withdrawal of Vioxx for safety concerns.

Congressional investigations have focused on allegations the agency silenced its own employees who tried to raise safety concerns on the antidepressants and Vioxx.

Drug Firms, Doctors Sued Over Suicide

Wed, 06 Oct 2004 00:00:00 -0700

Parents of an 11-year-old boy who committed suicide after taking antidepressant medications has sued the two companies that make the drugs and three health professionals who oversaw the boy's care.

In a lawsuit filed Tuesday in Douglas County District Court, David and Debra Jackson contend that the Oct. 10, 2002, hanging death of their son, Jacob, was the result of side effects from the antidepressant drugs Zoloft and Effexor.

On Sept. 14, the Food and Drug Administration's medical advisory group decided that antidepressants should come with a warning that they can spur suicidal behavior in children and teenagers.

The lawsuit alleges that Pfizer Inc. "failed to adequately test, evaluate and otherwise study the pediatric effects of Zoloft before marketing it to the public."

Spokeswomen for Children's Hospital and Immanuel Medical Center said their hospitals' attorneys had not seen the lawsuit and they would not immediately comment. Officials at Pfizer did not return a telephone call Wednesday seeking comment.

A spokesman for Wyeth, Lowell Weiner, said the company had not seen the lawsuit. However, Weiner said, Effexor is not recommended for use with pediatric patients.

Also named as defendants are Sharon S. Cannon, Ph.D., and Dr. Michelle M. Cassidy of Children's Hospital; and Dr. Michael L. Coy of Alegent Health-Immanuel Medical Center.

None of the defendants warned that "Jacob should be watched closely for signs that his condition was getting worse," the lawsuit said.

The lawsuit, filed by attorney Andrew J. Hilger, said Jacob began taking Zoloft on Sept. 9, 2002, on Cannon's recommendation.

Jacob's behavior worsened to include intensified agitation and suicidal desires, the lawsuit said.

Jacob's Zoloft dosage was increased three times between Sept. 17 and Oct. 2 on the recommendations of Cannon, Cassidy and Coy, the lawsuit said. On or about Oct. 8, Cassidy advised gradual decrease of the Zoloft dosage and prescribed the drug Effexor, the lawsuit said.

Two days later, Jacob was found dead in his parents' basement.

A Belated Admission On Antidepressants By the FDA

Thu, 16 Sep 2004 00:00:00 -0700

The Food and Drug Administration finally acknowledged publicly this week what some in the drug industry had known for a while but had declined to reveal: Antidepressants drugs such as Effexor, Paxil, Zoloft and Prozac appear to cause a small number of children and teenagers who use them to become suicidal or have suicidal thoughts.

And a scientific advisory committee voted 15-8 on Tuesday to recommend to the FDA that it put a "black box" warning on the labels for the antidepressants about the suicide risk for the youths who take them.

Legitimate questions have arisen about whether the drug industry wanted to keep quiet drug-test results that might hurt profits and about a federal agency more attuned to not irritating the drug industry than protecting the public welfare.

In February the FDA put a lid on findings by its own analyst, Andrew Mosholder, who warned of a link between use of the drugs and youth suicide.

Now he's been vindicated, and there's a bipartisan push in Congress to find out why this information was kept quiet for so long.

This week, Robert Temple, director of the FDA office of medical policy, said a review of 15 clinical trials some kept secret for years by drug companies show "there is an increase in suicidal thinking and action that is consistent across all the drugs."

There's also reason to believe that the danger of suicide from the drugs, however few children or teenagers it might affect, is not offset by doing good for many others.

"What is troubling is that millions of antidepressant prescriptions are written for depressed kids, when the facts show that six of the seven anti-depressants tested in pediatric trials did not show efficacy in kids," Rep. Greg Walden, R-Ore., said last week.

A House investigations subcommittee is studying use of the drugs and the suppression of clinical trial findings about their effects.

The industry has said the usefulness of the drugs remains undetermined even though almost 11 million prescriptions are given out a year.

Some parents strongly believe antidepressants have helped their children.

But other parents whose children have committed suicide while using antidepressants have criticized the FDA for taking too long to acknowledge the risks.

And British health authorities restricted most antidepressants for children and teenagers last December.

Congress must ensure that the information from drug trials is made public and that the FDA is not a party to suppressing information discomforting to the drug industry.

Parents have a right to know all of the risks their child takes with a drug, even if the risks are slight.

And if the FDA doesn't know what the risks of a drug are, why is it approving their use at all?

Prozac Linked To Child Suicide Risk

Tue, 14 Sep 2004 00:00:00 -0700

Prozac, the only antidepressant certified as safe for children, may make kids more suicidal, according to evidence out Monday.

A large new study added to previous research on Prozac shows that kids taking the drug have about a 50 percent higher risk of suicidal thoughts and suicide attempts than those getting placebos, says Robert Temple, director of the Office of Drug Evaluation at the Food and Drug Administration.

Temple spoke at the first day of hearings on potential label changes for antidepressants taken by more than a million children and teenagers. The discussion continues today, and an advisory committee could end the day by asking for tougher warning labels on all antidepressants taken by kids. The FDA typically follows the advice of its advisory committees.

Following a February hearing, the FDA in March asked drug companies to relabel 10 antidepressants, warning that young patients should be watched for worsening depression and anxiety. Critics at the time derided that move as "too little, too late," considering that, in December, British drug regulators had advised doctors to prescribe only Prozac for depressed kids.

Other major antidepressants prescribed for kids already have been found to raise the risk of suicidal behavior. Prozac had been an exception. "What's interesting and persuasive is that these studies now all lean the same way," Temple says.

So far, only Prozac has been found to be effective in children and teens, although the other drugs, approved for adults, are prescribed to children as an off-label use.

There were no suicides in the antidepressant studies of about 4,600 children. The increased risk for suicidal behavior is small: About two to three kids in a group of 100 become more suicidal because they're on antidepressants, says Tarek Hammad, medical reviewer for the FDA.

Dozens of parents testified at the hearing that antidepressants had caused their children to kill themselves or others. Their claims were "passionate and plausible," says psychiatrist Wayne Goodman, chairman of the FDA advisory panel.

But other parents and psychiatrists said the popular pills, such as Zoloft and Celexa, are saving lives every day.

Drug company spokesmen argued that antidepressants are safe. Company studies show most suicide attempts by children on Zoloft are linked to stress, not to taking the drug, says Steve Romano of Pfizer Inc., which makes Zoloft.

Although antidepressants seem to generate more suicidal behavior, "we can't forget all those who are protected from suicide by treatment," Goodman says.

There may be a group of kids who are particularly vulnerable to dangerous effects, but the limited studies so far don't suggest how they can be identified, FDA officials say.

FDA Admits Drugs' Risks

Tue, 14 Sep 2004 00:00:00 -0700

Top Food and Drug Administration officials said publicly for the first time Monday that scientific trials of frequently prescribed antidepressants have powerfully demonstrated that children who took the medications faced an increased risk of suicide.

Testifying before two FDA advisory committees, the officials said a recent study contracted by the FDA and conducted by Columbia University confirmed the findings of an internal analysis early this year: In clinical trials, the drugs almost doubled the incidence of suicidal behavior in children.

``What's striking about it is the consistency,'' said Dr. Robert Temple, director of the FDA's office of drug evaluation, referring to the medications' effects on young people.

More than 4,000 children ages 6 to 18 participated in the clinical trials. None of the children killed themselves, although hundreds experienced suicidal behavior or thoughts. Of the 40,000 adults who have participated in clinical trials for the antidepressants, 30 have committed suicide, according to the FDA.

The agency, under mounting criticism for its approach to regulating antidepressants for children, is seeking advice from the two committees on the necessity of further regulation. The committees are expected to announce their suggested regulatory approach today at the culmination of a two-day meeting.

Concerns about a possible link between the drugs and suicide were raised in the media and by some psychiatrists in 1990. The FDA convened an advisory panel on the topic but issued no warnings. Anecdotal evidence of such a link continued to accumulate, and in December the British counterpart of the FDA effectively prohibited physicians from prescribing a range of antidepressants to children, citing an increased risk of suicide.

In March, after hearings where parents told of the effects these drugs had on their children, the FDA ordered manufacturers of 10 frequently prescribed antidepressants Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Effexor, Wellbutrin, Serzone and Remeron to include warnings about an increased risk of deepening depression or even suicide on product labels and urged patients and their families to report any changes in behavior to their doctors.

Members of Congress from both parties have joined parents in criticizing the FDA for suppressing the results of the internal study, which showed a clear link between the drugs and youth suicide. That study became public after it was leaked to the news media.

But Temple said he was not sorry for waiting for the Columbia study before concluding that the data suggested a clear link between the drugs and suicidal behavior among children and teens.

It would be dangerous, he said, to prematurely rule out these drugs as possible treatment for childhood depression because there are few medical remedies available for the illness. Depression plays a significant role in suicide, the third-leading cause of death in teens.

``We've thought all along, it is extremely important to get as right an answer on this as we can,'' Temple told reporters.

Prozac Raises Child Suicide Risk

Tue, 14 Sep 2004 00:00:00 -0700

Children who take the anti-depressant Prozac are at greater risk of attempting suicide, say US experts.

The drug is currently the only anti-depressant which doctors can prescribe to under-18s in the UK.

Other similar drugs are considered too dangerous because previous studies have linked them to an increase in suicidal tendencies.

However, an analysis by the US Food and Drug Administration has found that Prozac too may pose a risk.

The analysis was overseen by Dr Robert Temple, director of the FDA office of drug evaluation, who gave evidence on Tuesday at a hearing to determine whether tougher warning labels were needed for anti-depressants.

He said: "I think we now all believe there is an increase in suicidal thinking and action that is consistent across all the drugs."

On average, the analysis, carried out by experts at Columbia University, New York, found anti-depressants taken by children will cause an extra 2% to 3% to have increased suicidal thoughts.

Relative risks of suicidal behavior were highest among young people taking Luvox, Effexor and Paxil and lower but still heightened among those taking Celexa, Zoloft and Prozac.

Dinah Morley, of the charity Young Minds, told BBC News Online: "Children who are put on these heavy duty drugs are very ill, and sadly more likely to commit suicide anyway.

"We would urge the greatest care possible to be taken in using these medications, but there are times when a young person is so deeply depressed that anything that may help must be considered because the alternative is death."

A Department of Health spokesperson said: "The Medicines and Healthcare products Regulatory Agency is reviewing these new data and will seek the advice of the Committee on the Safety of Medicines on what if any implications there are for the current advice that the balance of benefits and risks of Prozac (fluoxetine) is favourable in the treatment of depression in children and adolescents.

"As with all medicines, the MHRA/CSM keep the safety of fluoxetine under critical review."

Antidepressants Need Stronger Warnings

Tue, 14 Sep 2004 00:00:00 -0700

Antidepressants such as Paxil and Prozac should come with strong warnings that they raise the risk of suicidal thoughts and behavior in some children and teen-agers, a U.S. advisory panel concluded on Tuesday.

The U.S. Food and Drug Administration's panel of outside experts voted 15-8 to recommend warnings on the drug labels set off in a "black box," the strongest type of warning the government uses for prescription drugs.

Evidence from two dozen clinical trials of nine of the newest antidepressants showed children treated with the drugs were more likely to report suicidal thoughts or actions, panel members concluded. No suicides occurred during the trials.

"The purpose is to put physicians on notice that this group of medicines can cause problems," said panel member Dr. James McGough, a child and adolescent psychiatrist from Los Angeles.

Robert Gibbons, a panel member and statistician from the University of Illinois-Chicago, stressed the risk was "very small."

An FDA analysis concluded two or three out of every 100 young people treated with antidepressants might be at higher risk of suicidal behavior. In studies, worrisome actions ranged from writing a suicide note to attempting an overdose.

Any message in a black box would need to appear prominently in advertisements for the medicines, FDA officials said.

Prozac maker Eli Lilly said in a statement it "shares the concerns expressed by some committee members that (a black box) could discourage the use of appropriate treatment."

Lilly and other manufacturers promised to work with the FDA to decide how best to warn doctors, parents and patients and stressed the drugs' potential to prevent suicide.

"When people with depression are left untreated, 15 percent will actually commit suicide," Lilly said.

ALL NINE DRUGS STUDIED

The panelists said safety concern applied to all nine drugs studied, including Prozac, GlaxoSmithKline Plc's Paxil and Wellbutrin, Pfizer Inc.'s Zoloft, Forest Laboratories Inc.'s Celexa, Wyeth's Effexor, Solvay SA's Luvox and Akzo Nobel NV's Remeron were also reviewed.

Bristol-Myers Squibb's Serzone was also included, but the company discontinued the drug earlier this year.

The black box warnings should also appear on older antidepressants such as tricyclics, the panel said.

Data on suicidal behavior varied among drugs, but "we are unable to conclude any single agent is free from risk at this time," said Dr. Lauren Marangell, a panel member and psychiatrist at Baylor College of Medicine in Houston.

The black box should also convey results from studies of drugs that failed to show effectiveness in children, some panelists said. Only Eli Lilly and Co.'s Prozac has been proven effective and is FDA-approved for treating pediatric depression.

About 7 percent of antidepressant prescriptions are written for children, FDA officials said.

The FDA first became aware of a possible link to suicidal behavior in May 2003. Critics charge the agency was slow to act and instead chose to discount the findings of one of its own researchers.

In March 2004 the FDA advised doctors and parents to watch for signs of worsening depression or suicidal thoughts in patients taking the newer antidepressants.

But British authorities had already told doctors last year to avoid prescribing most antidepressants to children because of worries over possible suicidal behavior.

The FDA has committed to updating the drug labels, but has not said when officials will make a final decision. The agency usually follows the advice of its advisory panels.

Feds Warn on Children and Antidepressants

Mon, 13 Sep 2004 00:00:00 -0700

Tom Woodward's 17-year-old daughter Julie committed suicide by hanging herself. He blamed the antidepressant that the teen had been taking for seven days.

"We are certain that Zoloft killed our daughter," said Woodward, one of more than 70 speakers enveloping federal health advisers Monday in an outpouring of emotion, tears and anger.

Others witnesses, like Cynthia Wainscott, urged the Food and Drug Administration not to take away drugs that have reduced suicide rates among depressed youths.

Two FDA advisory panels are considering whether agency action including stronger warning labels is needed on antidepressants because they have been linked to suicidal tendencies among children who take them. The joint panel will weigh the benefits of nine drugs given to depressed children against the risk that the remedies may increase suicidal thoughts and actions.

"Drug companies have purposely deceived the public about the safety and efficacy of their drugs," Woodward said, calling for a strong, black warning on packaging for popular antidepressants.

Susan Bro, spokesman for Zoloft manufacturer Pfizer, would not comment on Woodward's allegations because of pending litigation. Zoloft, she said, is a "safe and effective drug when used as prescribed."

Wainscott showed panel members a photograph of her granddaughter Jessi, who she said began suffering from depression at age 11. Now 15 and on medication, Jessi has returned to her normal self, her grandmother said.

"Tell them not to do anything that will make people afraid to go for help," Wainscott said Jessi told her. Wainscott, chair of the National Mental Health Association, quoted her granddaughter as saying antidepressants meant "there are no invisible strings pulling me down."

Tarek Hammad, an FDA senior medical reviewer, told the panel an additional 2 percent to 3 percent of children are likely to incur increased suicidal thoughts from taking any antidepressant

He told reporters that looking at all the drug company studies created a complete picture. "Then, you can see significant findings," Hammad said.

Relative risks of suicidal behavior or thoughts were highest among youths taking Luvox, Effexor and Paxil and lower among youths taking Celexa, Zoloft and Prozac.

Untreated depression is a serious illness that threatens the children's lives, said Dr. Laurence Greenhill, speaking on behalf of the American Academy of Child and Adolescent Psychiatry, which represents 7,000 child psychiatrists. He said he found it reassuring that the FDA's detailed analysis did not find a single completed suicide among 4,440 depressed youth in drug company-sponsored clinical trials.

Parents whose children are locked up in prison, prematurely dead or survivors of attacks by rampaging teens on antidepressants wore T-shirts and pins and carried photographs of their lost loved ones.

"Where were you when I got shot?" demanded Mark Taylor, 21, who survived multiple gunshots fired by the Columbine High School attackers, including one teenage gunman who had been taking an antidepressant.

"As Americans, we should have the right to feel safe. And, if you were doing your jobs, we would be safe," Taylor said.

FDA epidemiologist Andrew Mosholder, who pushed for the closer look at suicidal behavior among children taking antidepressants, noted a clustering of serious events involving suicide within the first four days after youths discontinued Paxil treatment.

Mosholder was praised by grieving family members for requesting clarification last year from Paxil manufacturer GlaxoSmithKline. The data he received in May 2003 suggested a link between Paxil and increased suicidal acts among children taking it.

Dr. Robert Temple, director of the FDA's office of drug evaluation, told reporters he had no regrets delaying the testimony at a previous hearing because he still thinks Mosholder's data may be flawed.

Temple said it was "interesting and persuasive" that studies link all antidepressants to heightened suicidal thoughts and actions among youth. "They all lean the same way, including Prozac now," he said.

In about one-quarter of 200 studies on about 100 pharmaceutical products, the FDA changed the dosages for children, found new adverse reactions that occurred only among children or found the drugs didn't work in kids at all.

Drug Leads To Sons Suicide, Family Says

Tue, 10 Aug 2004 00:00:00 -0700

Had she known in May what she knows know, Wanda Custance said she might have been able to save the life of her scholar-athlete son.

Hoping to spare other families a tragedy like their own, Wanda and Gary Custance urge relatives to frequently check in with loved ones who are taking anti-depressants.

"People who are prescribed these drugs, they really have to be monitored closely," she said. "I felt I wasnt all that aware, other than I didnt like the idea of him taking it."

Perry Custance, a 22-year-old senior at Oregon Institute of Technology, had been a distance runner from South Medford High School, and held the schools records in the 1,500- and 3,000-meter run. He also was the all-American scholar-athlete honor at OIT in 2003.

Wanda said she knew her son was prescribed the anti-depressant Lexapro around the first of April after he sought treatment for a side ache and lower back pain. Perry took the medication until June.

"We think he stopped taking it probably around the third or fourth (of June)," his mother said. And then it was the weekend of June 12 that Perry died of an apparent self-inflicted gunshot wound near his family home outside Ruch.

"His friends had said hed gotten really, really down about a week before the suicide," she said, adding that his handwritten class notes were illegible during that time.

Because Perry was an adult, his medical records are not available to his parents. But as far as they knew, their son was not depressed.

Lexapro is approved for the treatment of anxiety and major depression, and no other medical uses are listed on the manufacturers Web site. The site warns that discontinuing the medication against a doctors advice might worsen depression or anxiety symptoms.

Newer anti-depressants such as Lexapro, known as selective serotonin reuptake inhibitors (SSRIs), have come under recent scrutiny.

In March, the Food and Drug Administration asked makers of SSRIs to include warnings that children and adults might become more depressed or suicidal while taking them, and close supervision particularly at the start of treatment is required.

The affected drugs include Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron. More information is available at www.fda.gov on the Web.

Gary Custance wishes he had known about the warning.

"I would have liked to have seen a warning label on the bottle," he said.

Gary Custance said his sons May 12 prescription bottle had no such warning.

The warnings are included in the drugs package insert, according to an Oregon Health & Sciences University specialist.

James Hancey, assistant professor of psychiatry at OHSU, said upon hearing the familys story, he doesnt think the medication caused Perry to take his own life.

"Too often people will start to feel better, then decide they dont need their medications any more, and they stop them," he said. "Because he went off the medication, the depression returned."

Hancey said medical literature for Lexapro does not suggest any correlation between stopping the medication, time passing, and then a suicide occurring.

"It was more likely a return of the underlying major depressive symptoms," he said.

He said that by and large, the anti-depressants end up saving lives although theres no way to track the number of prevented suicides.

But Perrys father doesnt buy it.

Gary Custance doesnt believe his son would have ended his life had he never taken Lexapro, but once he was on it, he should have stayed on it.

"Theres a serious problem with coming down from this stuff," he said, adding that his son should have had more intensive medical supervision. "They didnt monitor it like they should have."

Wanda Custance said questions that remain unanswered make her sons death more painful.

"I dont want to see anybody go through this," she said.

2nd FDA Review Confirms Antidepressant Risks: Report

Tue, 10 Aug 2004 00:00:00 -0700

A second review by the U.S. Food and Drug Administration has confirmed earlier findings that children who use certain adult antidepressants are at an increased risk of suicide, the Washington Post reported Tuesday.

Six months ago, the agency was criticized for withholding results of the first internal review, which found that children who use certain antidepressants known as selective serotonin reuptake inhibitors (SSRIs) were more likely to have suicidal thoughts. Drugs in this class include brand names such as Paxil, Zoloft, and Celexa. Only one SSRI, Prozac, has been FDA-approved for pediatric use.

The newer analysis reached the same conclusion as the first, the newspaper said. Prepared by FDA medical reviewer Tarek Hammad, it found that children who used the antidepressants during clinical studies had 1.78 times the risk of making a suicide attempt or "making preparatory actions towards imminent suicidal behavior," compared to children who had taken a nonmedicinal placebo.

The FDA hasn't publicly disclosed either report, and doesn't plan to discuss the data until a scheduled meeting in September, the Post reported.

Nine months ago, British authorities first warned doctors not to prescribe SSRIs to people under age 18, noting a tendency among young users to contemplate or commit suicide. Critics of the FDA in Congress and elsewhere allege that the agency is moving too slowly in its investigations, and is keeping important information from the public.

Since the British announcement, the FDA has changed its requirements on SSRI labeling, warning that doctors should closely monitor young users particularly when they begin treatment or change doses.

Anti-Depressants Risky For Kids, FDA Finds

Tue, 10 Aug 2004 00:00:00 -0700

Six months after the FDA withheld an internal finding that anti-depressant medications were associated with an increased risk of suicide among children, a second staff analysis has arrived at the same conclusion.

The agency has refused to publicly disclose either report, despite growing pressure from critics and Congress. Agency officials say they don't plan to discuss the data until a scheduled meeting in September, which would come nine months after British authorities warned physicians not to prescribe Paxil, Zoloft, Celexa and similar drugs to depressed children, and more than a year after the first concerns emerged.

The new analysis has renewed critics' complaints that the FDA is moving too slowly to address the concerns about suicide.

One leading expert who reviewed the two internal analyses said they had changed his thinking about the risks. "I didn't have access to the proprietary data" reflected in the FDA analyses, said Steven Hyman, former director of the National Institute of Mental Health, who initially felt British regulators had overreacted. Hyman reviewed the analyses at the request of the Washington Post.

"Now I would say from the data in front of me, with the exception of Prozac, there is concern about the risk-benefit ratio of antidepressants in children," said Hyman.

FDA officials have declined to release the new analysis, first reported by the Wall Street Journal, and said they were still reviewing the information. "It would be premature to discuss any conclusions and results," said spokeswoman Kathleen Quinn. "Other people are going to have an opinion about it, but we are still reviewing it."

The new analysis comes amid growing concerns that crucial information about the safety and effectiveness of the drugs has been withheld from public scrutiny. Two-thirds of the trials conducted by drug manufacturers found that the medications performed no better than sugar pills, but details of the negative trials were kept from doctors and parents.

Joseph Glenmullen, a Harvard psychiatrist and author of "Prozac Backlash," a book about the side effects of antidepressants, said one company, Wyeth, had warned doctors not to prescribe its anti-depressant Effexor for children: "The companies are coming to this conclusion, and the British came to this conclusion, and the Canadians and the rest of Europe and the FDA's own reviewer have come to this conclusion; why have they dragged their feet for over a year?"

The new "interim review" by FDA medical reviewer Tarek Hammad is a compilation of data that has no narrative or interpretation. But both Hyman and Glenmullen said it showed an increased risk for children taking the drugs similar to that found in February by another FDA scientist, Andrew Mosholder.

Hammad's review found that compared to depressed children who got sugar pills, children who got antidepressants had 1.78 times the risk of making a suicide attempt or "making preparatory actions towards imminent suicidal behavior."

Mosholder found that children getting antidepressants had 1.9 times the risk of "serious suicide-related events."

Multiple congressional investigations are under way into the controversy. The chairman of the Senate Finance Committee, Charles Grassley, R-Iowa, said in a statement Monday: "It's been almost nine months since British regulators issued new recommendations, and it's been six months since Dr. Mosholder made his determinations. Now, given this new information, it's fair to ask if the Food and Drug Administration is taking too much time to draw a conclusion."

The FDA's associate director for medical policy, Robert Temple, said in an April interview that officials believed a second analysis might provide a different answer than Mosholder's: "Andy thinks the results are unlikely to change from this analysis, and we are not so sure of that."

Temple said the agency had decided to withhold Mosholder's findings because "we didn't think it was time to present a conclusion about a study because we as an agency didn't want to present it... in the absence of all the data; you want to be careful about reaching premature conclusions."

Agency officials said then that they were concerned about whether the companies had classified suicidal cases properly, and referred the question to Columbia University scientists. But in a Feb. 18 memo, Mosholder warned that the new analysis would waste time: "In my view, it is unlikely that the new information will alter the basic finding of an association of serious suicide-related events with active treatment."

Given the risks, he urged the agency to take the interim step of officially discouraging the use of antidepressants other than Prozac for children. The FDA declined to do so but called for stronger warning labels to remind doctors to be vigilant about suicide for over a decade, the agency has said that depression, not antidepressants, causes suicidal behavior.

Tragic Teen Suicides Inspire Idea That Invites More

Sun, 20 Jun 2004 00:00:00 -0700

In heart-wrenching testimony before federal drug regulators last February, parent after parent related how their teens had committed suicide after taking prescription antidepressants. In one case, a father told of how his 17-year-old hanged herself after seven days on Zoloft, which her doctor had stressed was safe.

Such tragic stories have helped fuel a campaign by some patient advocacy groups to pressure the Food and Drug Administration (FDA) to ban a family of widely prescribed antidepressants for anyone under 18. They say clinical studies show increased suicidal behavior and a track record that's no better than placebos (sugar pills) in fighting depression. British regulators banned most antidepressants for minors last December.

Banning these drugs in the USA would be a premature move that could jeopardize the health of more than a million children getting relief from the misery of depression.

Instead, concerns raised about the drugs' safety can be addressed through improved warning labels while more studies are conducted on their effects on children. That's the sensible approach taken by the FDA.

The FDA says it has no proof the pills cause suicidal behavior in children. Even so, it asked drugmakers in March to add warnings to 10 widely used antidepressants that instruct parents and doctors to closely monitor behavior for such changes as increased anxiety, impulsiveness or aggression.

Evidence that antidepressants are not harmful for children include:

No suicides were reported in 25 studies of more than 4,000 children taking the pills. Many incidents of self-harm initially listed as suicide-related may have been misidentified, such as children slapping or superficially cutting themselves, FDA officials said.

A 2003 World Health Organization study found that the teen suicide rate dropped in 15 nations by 33% in the past 15 years, coinciding with the widespread use of the antidepressants. In the USA, the suicide rate among adolescents dropped 25% during the past decade, the Centers for Disease Control and Prevention reported June 11.

The American Academy of Child and Adolescent Psychiatry says the benefits of the pills outweigh the risks, and that links to suicidal behavior haven't been established.

The debate has produced one positive result: calls that all clinical studies positive and negative be placed on a public registry so doctors and parents can review them. The American Medical Association endorsed the concept last week. That followed a suit filed June 2 by New York's attorney general against GlaxoSmithKline, manufacturer of the antidepressant Paxil, for allegedly suppressing negative results from studies on the drug's impact on children. Glaxo says it provided all studies to the FDA.

Supporters of a ban say evidence of the harmful effects these antidepressants have on minors is convincing. But they ignore the significant drop in the suicide rate since the medicine has been prescribed for children.

More studies focused on children will help the FDA reach a definitive conclusion. In the meantime, tougher warnings can help avert future tragedies.

Without more persuasive evidence of harm, banning antidepressants outright for children could leave too many anguished kids in the grip of debilitating depression.

FDA Was Urged To Limit Kids' Antidepressants

Fri, 16 Apr 2004 00:00:00 -0700

A medical reviewer at the Food and Drug Administration recommended earlier this year that the agency adopt a tough "risk management strategy" urging doctors to stop prescribing most antidepressants to children, but the FDA rejected his advice and instead asked drug companies only to warn patients and doctors about possible risks to young patients, The Chronicle has learned.

Dr. Andrew Mosholder, an epidemiologist in the FDA's Office of Drug Safety, analyzed 22 clinical trials of nine antidepressants and concluded that the drugs appeared to double the risk of suicidal behavior among children. A copy of his report, obtained by The Chronicle, shows that Mosholder recommended that the FDA adopt a "risk management strategy directed at discouraging off-label pediatric use of antidepressants" other than Prozac in the treatment of children with depression.

As reported by The Chronicle at the time, Mosholder's presentation to an FDA advisory committee in February was removed from the agenda by his superiors at the agency.

The FDA opted not to issue a recommendation to doctors that they stop prescribing the drugs to children, as British regulators did last year and as Mosholder had urged. Instead, the agency took a much milder step last month and called on drug companies to include warnings in the prescribing information provided to doctors about the risks of negative side effects among patients who start taking a drug or increase its dosage.

The agency also contracted with a group of doctors at Columbia University to reanalyze the clinical trial data provided by drug companies, the same data Mosholder reviewed, to see whether suicidal events were correctly classified. Agency officials have argued that the data from those trials are sometimes vague and that some behaviors such as a child slapping herself in the head may have been labeled wrongly as suicidal events by researchers conducting the drug company-funded studies.

Committees in both the House and Senate have opened investigations into the withholding of Mosholder's report and into efforts by the FDA's Office of Internal Affairs to identify the staff members who leaked information to The Chronicle.

One congressional source predicted that the investigation was likely to trigger congressional hearings. "I think eventually there will be some hearings," the source said. "There's no way to put a good face on this decision not to allow Dr. Mosholder to present his conclusions to the advisory committee."

Despite repeated requests, senior FDA officials declined to comment for this story.

However, in a letter sent Wednesday to House Energy and Commerce Committee Chairman Joe Barton, R-Texas, an agency representative defended the agency's decision to keep Mosholder from presenting his report. Agency officials "decided that having Dr. Mosholder present his conclusion to the Advisory Committee, with the appearance that it was an agency determination, would be potentially harmful to public health as it might lead patients who were actually benefiting from the use of these drugs to inappropriately discontinue therapy," wrote Amit Sachdev, acting associate commissioner for legislation.

Critics of the FDA's handling of the antidepressant ruling reacted to details of the Mosholder report with outrage. "It's astounding that FDA officials actively blocked vital, possibly life-saving information about the suicide risks to children" of these drugs, said Vera Sharav, president of the Alliance for Human Research Protection, an advocacy group. "Every day that doctors and parents are not informed about the risks, children are at risk of dying."

In arguing that the agency should take strong action rather than wait for the reanalysis by the Columbia University group, Mosholder made much the same point in his report.

"Given the strength of the association shown by the present data, the clinical importance of the apparent effect, and the fact that the additional analyses are likely to take several more months to complete while considerable numbers of pediatric patients are being exposed to these drugs, I favor an interim risk management plan," he wrote.

Mosholder's report found that 74 children out of 2,298 who took antidepressants engaged in a "suicide-related event," compared to 34 of the 1, 952 patients who took placebos, or fake pills. The drugs presenting the highest risk were Effexor and Paxil, which nearly tripled the risk of a suicidal event, and Zoloft, which more than doubled the risk, his research showed.

Prozac, which is now available in generic form, had the lowest risk among the major drugs, and is the only new-generation antidepressant specifically approved by the FDA for treating depressed children. For that reason, Mosholder recommended that Prozac alone continue to be prescribed to children.

But since drugs that have been cleared by the FDA for treatment of adults can be prescribed "off label" to children, other drugs including Paxil, Zoloft, Effexor, Luvox, Remeron, Celexa, Serzone and Wellbutrin are widely prescribed for children and teenagers. The FDA estimates that nearly 11 million antidepressant prescriptions were written for children in 2002, 2.7 million of them for children under 12.

Joseph Glenmullen, a clinical instructor in psychiatry at Harvard University, said the agency's withholding of the Mosholder report and its failure to take stronger action was an example of the FDA's failure to protect the public from the dangerous side effects of antidepressants.

"They have mishandled this issue for 15 years," he said. "They have not adequately protected American children."

Zoloft Suicide Side Effects Lawyer Suicidal Injury Lawsuit

Fri, 16 Apr 2004 00:00:00 -0700

DOWNLOAD OUR Zoloft INFORMATION PACKAGE

Injured by Zoloft?

On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.

The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.

In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk. The FDA has recently urged the makers of Zoloft and other SSRI antidepressants to add a warning about suicidal behavior. The FDA stated that patients using Zoloft and other antidepressants should be watched closely for suicidal tendencies. The FDA advisory panel suggested the new warnings after an emotional hearing with testimony from the parents of children and teenagers who attempted suicide or took their own lives after starting antidepressants. The expanded warnings on antidepressant labels advise health-care providers to "carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either decreases or increases."

Antidepressant Suicide Risk
Zoloft belongs to a newer class of antidepressants called SSRIs, or selective serotonin reuptake inhibitors. A British study found an increase in suicide attempts among children taking antidepressants versus those taking sugar pills. The U.S. surgeon general estimates there are 30,000 suicides every year in the United States. According to researchers with Columbia University, 10 percent of all youth suffer from depression, and 1,883 children ages 10 to 19 years old killed themselves in 2001.

Antidepressant Risk in Heart Disease Patients
In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs. During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%. Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However, their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.

If you or a loved one took Zoloft and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.