Yourlawyer.com (Cymbalta News) http://www.yourlawyer.com/topics/overview/cymbalta Sat, 21 Nov 2009 01:51:41 -0800 pixel-app en Antidepressants Linked to Sudden Cardiac Death in Women http://www.yourlawyer.com/articles/read/16217 Wed, 11 Mar 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16217 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.

]]> Lyrica, Cymbalta Fibromyalgia Promotions Questioned http://www.yourlawyer.com/articles/read/16016 Mon, 09 Feb 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/16016 Cymbalta and Lyrica.

Fibromyalgia, defined as a chronic, widespread pain condition of unknown origin, is a controversial diagnosis.   No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes.  While the Associated Press said that doctors agree that suffers' symptoms are real, they don't agree that a disorder called fibromyalgia is behind them.  But real or not, there is obviously a huge market for fibromyalgia treatments.

Pfizer's Lyrica was the first prescription medication approved to treat fibromyalgia, though no one can explain exactly how it works. Lyrica was first approved to treat epilepsy.  In 2004, the drug was reviewed by the Food & Drug Administration (FDA) as a remedy for diabetic nerve pain.  According a  New York Times report published last January, the reviewers recommended against approving the drug, citing its side effects.  Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness.

But the FDA ignored the advice of Lyrica reviewers, and approved it anyway.  Then Pfizer asked the FDA to expand the approved uses of Lyrica to include the treatment of fibromyalgia, and the agency did so in June 2007.  According o the Times report, in clinical trials, patients taking Lyrica reported that their pain fell on average about 2 points on a 10-point scale, compared with 1 point for patients taking a placebo. About 30 percent of patients said their pain fell by at least half, compared with 15 percent taking placebos.

Pfizer’s success has encouraged other drug makers to seek approval for their own fibromyalgia drugs.  Eli Lilly's antidepressant Cymbalta received such approval last June.

According to the Associated Press, both drug makers are spending big bucks to promote not only their drugs, but fibromyalgia as well.  According to the report, key components of their marketing onslaught include more than $6 million in grants to nonprofit groups to pay for fibromyalgia medical conferences and educational campaigns.  And that was only in the first three quarters of 2008, the Associated Press said.   It's also more than the drug makers gave towards Alzheimer's Disease and diabetes, which are universally recognized as real diseases.

One doctor interviewed by the Associated Press called Eli Lilly's and Pfizer's fibromyalgia promotion efforts "disease mongering".  That doctor, Frederick Wolfe,  was lead author of the guidelines defining fibromyalgia in 1990, but now doubts the very existence of the disease.

Despite such concerns over the tactics used by Eli Lilly and Pfizer, they do seem to be working.  According to the Associated Press, between the first quarter of 2007 and the fourth quarter of 2008, sales rose from $395 million to $702 million for Lyrica, and $442 million to $721 million for  Cymbalta.

]]> Eli Lilly Withdraws Cymbalta Application http://www.yourlawyer.com/articles/read/15593 Mon, 01 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15593 Cymbalta, already approved as an anti-depressant, faced questions from U.S. health regulators over efficacy and dosage recommendations.

Lilly said its move to pull the supplemental New Drug Application (NDA) for Cymbalta—known generically as duloxetine HCl—was prompted by  FDA reviewers' questions regarding  “the design of supporting Lilly studies and statistical methodology,” said Reuters.  The report said that Lilly plans to resubmit its application in early 2009, “after adding data from a recently completed study in chronic osteoarthritis pain of the knee.”  

The recent decision does not affect Cymbalta’s current FDA-approval for the drug’s use for major depressive disorder, generalized anxiety disorder (DAD), management of diabetic peripheral neuropathic pain, and management of fibromyalgia, Lilly told Reuters.

As an antidepressant, Cymbalta has raised safety concerns. When the FDA issued a  prior warning about the potential for suicidal thinking in adults taking antidepressants, it specifically singled out Cymbalta because of a higher than expected suicide attempt rates revealed in studies.  Cymbalta has been associated with suicide risk since its clinical trials and one review of Cymbalta found that 11 of nearly 9,000 women taking it for urinary incontinence tried to commit suicide. The fact that these patients were suffering from urinary incontinence and not depression is significant because the drug companies have long argued that antidepressants are used by depressed people who experience a higher likelihood of committing suicide.

Concerns about suicidal behavior surfaced in 2004 when  Traci Johnson, a healthy volunteer involved in a trial at Eli Lilly's clinic at Indiana University Medical Center in Indianapolis, killed herself in one of the clinic’s showers.  Johnson, who did not suffer from depression, was taken off the drug and given a placebo four days before she hung herself in one of the clinic's showers.  She was the fifth patient to commit suicide after taking Cymbalta in clinical trials. After her death, one-fifth of the volunteers quit the Cymbalta trial.

The FDA began reanalyzing hundreds of studies of the drugs 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 with suicidal behavior.

]]> Cymbalta Suicide Data Withheld by FDA http://www.yourlawyer.com/articles/read/14226 Wed, 16 Apr 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14226 Cymbalta, an antidepressant made by Eli Lilly, has been linked to suicides.  Although suicide is sometimes the tragic outcome of depression, some of those who have committed suicide while taking Cymbalta were not being treated for depression - or for any other mental illness.  Unfortunately, despite reports of suicides not linked to depression, the Food & Drug Administration (FDA) has been slow to act on Cymbalta, and has actually concealed information on some suicides that occurred during clinical trials conducted by Eli Lilly, the drug's maker.  

Cymbalta - known generically as Duloxetine - was approved by the FDA in 2004 to treat depression and peripheral neuropathy.  By the end of that year, Cymbalta sales topped $61.3 million. At some point—the date is undisclosed—Eli Lilly began testing Duloxetine under the brand name Yentreve as a treatment for urinary incontinence.  In 2004, Traci Johnson, a healthy 19-year-old college student volunteer enrolled in a Cymbalta/Yentreve trial hung herself by a scarf from a shower rod in Lilly's Indianapolis, IN laboratory while withdrawing from the drug.  Johnson had not been diagnosed with depression, and had been screened for mental health issues prior to being accepted into the trial.  

Eli Lilly has claimed that Johnson's tragic death was an isolated incident. Still, the FDA ordered Eli Lilly to stop accepting new volunteers for the study and to have continuing participants evaluated by an independent psychiatrist and sign new consent forms. But in another Cymbalta trial of 4,124 depressed patients just weeks later, four more participants committed suicide.  In 2005, Eli Lilly stopped seeking approval for Yentreve in the US. The company did not say why the drug was not approved, nor was it required to do so by the FDA.

The publicity surrounding the Johnson suicide raised concerns among researchers and physicians about Cymbalta's safety. Some went to the FDA looking for answers, but the agency was silent.  The FDA said that the data from the clinical trials in question represented a "trade secret" that could not be released as Yentreve was never approved. This might be a perfectly acceptable reason for drug not on the market, but Eli Lilly was conducting these clinical trials to gain approval for new uses of Duloxetine.  Meanwhile, millions of people were already taking it as Cymbalta, and had no idea it had been associated with these suicides. Unfortunately, the FDA didn't seem concerned that it might be protecting so-called trade secrets at the expense of patient safety.

Cymbalta - under the name Yentreve - was already being sold as a urinary incontinence treatment overseas, where a disturbing pattern of suicides emerged.  According to overseas data, twice the expected number of suicide attempts among middle aged women were seen with the drug-- 400 per 100,000 person-years versus a baseline of 160 per 100,000 person-years.   Other sources also recorded disturbing incidents of Cymbalta suicides.  

By presenting the FDA with a Freedom of Information Act request on behalf of "Independent on Sunday," reporter Jeanne Lenzer learned of 41 deaths and 13 suicides associated with Cymbalta, which did not include Johnson's or the four suicides that followed.  The data obtained by Lenzer didn't include the other suicides because those clinical trials fell under the FDA's trade secret rationalization.

Antidepressants like Cymbalta have been linked to hundreds of suicides.  In most cases, drug makers blame those incidents on the depression itself.  But the Cymbalta suicides indicates there is more to the story. Unfortunately, because the FDA has insisted on protecting Eli Lilly, the whole story might never be known.

]]> Cymbalta Diabetic Nerve Pain Claims Deceptive, FDA Says http://www.yourlawyer.com/articles/read/13175 Wed, 03 Oct 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/13175 Food & Drug Administration (FDA) is telling Cymbalta’s maker, Eli Lilly, to end the promotion.

Cymbalta is used to treat depression, anxiety and diabetic nerve pain.   In 2005, new warnings were added to the Cymbalta label about its potential to cause liver problems.  Doctors were warned to avoid prescribing Cymbalta to patients with pre-existing liver disease.  That label update also included warnings about a variety of side effects linked to Cymbalta, including  hepatitis, jaundice and other liver-related problems in patients using Cymbalta.  The FDA also recently issued a new warning about the potential for suicidal thinking in adults taking antidepressants, but the agency specifically singled out Cymbalta because of a higher than expected rate of suicide attempts in recent studies.

Cymbalta, launched in 2004, has become a strong seller for Eli Lilly. It registered $1.3 billion in sales last year, an increase of 94%. In the second quarter this year, only top-seller Zyprexa brought in more revenue than Cymbalta's $519.5 million.   No doubt, these stellar figures can be attributed to the aggressive marketing of Cymbalta by Eli Lilly.

The promotional campaign that has drawn the FDA’s attention consists of a mailer that promotes Cymbalta as a treatment for diabetic nerve pain.  The promotional material says  Cymbalta helps patients "experience less pain interference with overall functioning." It uses a series of bar charts to show how Cymbalta could ease their  pain.  But the FDA letter says the mailer overstates the drug’s effectiveness in treating diabetic nerve pain.   The letter says these claims are " false or misleading in that it overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use."  The FDA  said that the mailer downplayed Cymbalta’s risk for liver damage, and left out important information about dangerous interactions with other drugs.   The FDA asked Eli Lily to cease use of the mailer, as well as several other promotional materials that made the same claims about Cymbalta.

An Eli Lilly spokesperson told the Indianapolis Star that the company is working with the FDA "to gain a greater understanding of their concerns." He said the company will take action once it has "more clarity" on the agency's comments.

]]> FDA Again Warns About Suicidal Thoughts and Behavior Among Young Adults on Antidepressants http://www.yourlawyer.com/articles/read/12808 Thu, 03 May 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12808
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 http://www.yourlawyer.com/articles/read/12803 Wed, 02 May 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12803
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 http://www.yourlawyer.com/articles/read/12374 Thu, 14 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12374
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 http://www.yourlawyer.com/articles/read/12375 Thu, 14 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12375     
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 http://www.yourlawyer.com/articles/read/12368 Wed, 13 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12368
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.]]> FDA Warns of Suicide Risk for Paxil http://www.yourlawyer.com/articles/read/11688 Fri, 12 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11688 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.]]> Cymbalta to Carry Expanded Warning Concerning Potentially Serious Liver-Related Problems http://www.yourlawyer.com/articles/read/10831 Tue, 18 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10831
Cymbalta, which already carries a Black Box Warning regarding “Suicidality in Children and Adolescents,” is now linked to post-marketing reports of hepatic injury (including hepatitis and cholestatic jaundice) that suggest “patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage.”
The FDA’s letter and the new Cymbalta label are posted online at http://www.fda.gov/medwatch/safety/2005/safety05.htm#Cymbalta.

The new labeling extends the Precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.

"Some of these reports indicate that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage," Lilly said in its letter to doctors dated October 5.

]]> FDA Warns Again of Suicide-Antidepressant Link http://www.yourlawyer.com/articles/read/10166 Sun, 03 Jul 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10166
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 website with a notice about a higher-than-expected rate of suicide attempts in research with the nation's newest antidepressant, Eli Lilly & Co.'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 Orders Strong Antidepressant Warnings http://www.yourlawyer.com/articles/read/8651 Fri, 15 Oct 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8651
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. ]]> Cymbalta Lawyer Antidepressant Attorney Suicide SSRI Side Effects Lawsuit http://www.yourlawyer.com/topics/overview/cymbalta Fri, 15 Oct 2004 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/cymbalta DOWNLOAD OUR CYMBALTA INFORMATION PACKAGE

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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.

Our Dedicated Cymbalta Side Effects  Lawyers and Attorneys Have Years of Experience Handling Defective Drug Lawsuits!

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.

On October 17, 2005, Eli Lilly expanded its warning about potential liver-related problems with its depression drug, Cymbalta, and cautioned doctors against prescribing it to patients with chronic liver disease, U.S. health regulators announced.  The new label for the drug also contains reports of hepatitis, jaundice and other liver-related problems in patients using Cymbalta.

The FDA has recently issued a new warning about the potential for suicidal thinking in adults taking antidepressants, but the agency specifically singled out Cymbalta (generic: duloxetine) because of a higher than expected rate of suicide attempts in recent studies. Cymbalta is a relatively new antidepressant manufactured by Eli Lilly that has been associated with suicide risk since its clinical trials.

The warning comes after a review of Cymbalta by Eli Lilly; found that 11 of nearly 9,000 women taking it for urinary incontinence tried to commit suicide. The fact that these patients were suffering from urinary incontinence and not depression is significant because the drug companies have long argued that antidepressants are used by depressed people who have a higher likelihood of committing suicide.

Cymbalta has been associated with suicidal behavior since Traci Johnson, a healthy volunteer involved in a trial at Eli Lilly's clinic at Indiana University Medical Center in Indianapolis, killed herself in one of the clinics showers. Johnson, who did not suffer from depression, was taken off the drug and given a placebo four days before she hung herself in one of the clinic's showers on February 7, 2004. Johnson was the fifth patient to commit suicide after taking Cymbalta in clinical trials. After her death one-fifth of the volunteers have quit the Cymbalta trial.

The FDA approved Cymbalta for use as an antidepressant last August 2004 but it is not approved in the United States to treat urinary incontinence. Cymbalta is an important drug for Eli Lilly, as some analysts believe its annual revenues can reach $3 billion by 2009. Cymbalta recorded $94 million in revenues in five months that it was on the market last year and $107 million the first three months of this year. The most recent FDA warning about the risk of suicide associated with antidepressants was different in that it specifically focused on the risk to adults.

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.

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.

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 Cymbalta and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>