Yourlawyer.com (Lexapro News) http://www.yourlawyer.com/topics/overview/lexapro Sat, 21 Nov 2009 05:10:44 -0800 pixel-app en Another Study Links Antidepressants To Birth Defects http://www.yourlawyer.com/articles/read/17035 Fri, 25 Sep 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/17035 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.

]]> JAMA Oversight Committee to Look Into Lexapro Study Controversy http://www.yourlawyer.com/articles/read/16325 Mon, 30 Mar 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16325 American Medical Association  (JAMA) attempted to intimidate a critic of a Lexapro study it published.  According to The Wall Street Journal, the AMA has asked its oversight committee to investigate the charges.

The controversy centers on Dr. Jonathan Leo's criticism of a Lexapro study published in the JAMA.  Dr. Leo is a professor of neuroanatomy at Lincoln Memorial University in Harrogate, Tenn.

Earlier this month, Dr. Leo published an online letter in the British journal BMJ that criticized how the study's results were reported in the JAMA  last year. Dr. Leo also said the JAMA didn't disclose the author of the study's financial relationship with Lexapro's maker, Forest Laboratories Inc.  Forest has confirmed it has paid the study’s author for speeches, but not for his research, the Journal said.

Following publication of his letter, the  JAMA's  Editor-in-Chief called the dean of Dr. Leo's college demanding a retraction. In an earlier Wall Street Journal report on the “dust up”, the editor-in-chief called Dr. Leo a “nobody and a nothing”.  According to The Wall Street Journal,  Dr. Leo has also claimed that the JAMA's Executive Deputy Editor had told him "You are banned from JAMA for life. You will be sorry."  

As we reported last week, the flap prompted the Alliance for Human Research Protection to call for an investigation, as well as the suspension of both the Editor-in-Chief and Executive Deputy Editor at JAMA.  The Alliance is a group that has long criticized the ties between the drug industry and academia.  

In a letter to the chairman of the JAMA board of trustees, the Alliance said medical journal editors have a responsibility “to provide an open forum for scientific debate, and to preserve the scientific integrity of the journal and its content by ensuring against concealed conflicts of interest.” The Alliance contends that the JAMA editors not only “failed to meet this responsibility, they resorted to threatening retribution against a researcher who detected failures in their editing and gatekeeping processes.”  The Alliance letter charged that the incident involving Dr. Leo has raised questions about whether drug advertising influences JAMA’s publication of biased reports.

In a statement, the AMA said it has "formally referred" the matter to a seven-member Journal Oversight Committee.  According to The Wall Street Journal, the oversight committee is a standing body that has editorial responsibility for JAMA, including evaluating the performance of the Editor-in-Chief. The committee is made up primarily of medical academics.

According to The Wall Street Journal, the AMA statement said it takes the concerns raised over the Dr. Leo matter "very seriously." It said the AMA board will "give careful consideration to whatever is reported to it" by the oversight committee.


]]> JAMA Slammed Over Lexapro Study Debacle http://www.yourlawyer.com/articles/read/16317 Fri, 27 Mar 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16317 Lexapro study it published. According to The Wall Street Journal, the Alliance for Human Research Protection is calling for the suspension of two JAMA editors because of their role in the debacle. The Alliance is a group that has long criticized the ties between the drug industry and academia, the Journal said.

In a letter to the chairman of the JAMA board of trustees, Vera Sharav, President of the Alliance, wrote that the organization was "deeply concerned about the unbecoming and unethical conduct of the Editor-in-chief and Executive Deputy Editor of the Journal of the American Medical Association, who were reported to have used unprofessional and intimidating tactics against a conscientious academic, Dr. Jonathan Leo."

According to The Wall Street Journal, Dr. Leo criticized how results were reported in a JAMA study published last year that looked at the use of the antidepressant Lexapro in stroke victims. Dr. Leo also said JAMA didn't report the study's author had a financial relationship with Lexapro's maker, Forest Laboratories Inc.  Forest has confirmed it has paid the study's author for speeches, but not for his research, the Journal said.

Dr. Leo is s a professor of neuroanatomy at Lincoln Memorial University in Harrogate, Tenn.  His criticism of the JAMA Lexapro study appeared in a March 5 letter published by a British journal, BMJ, the Journal said.

The Alliances' letter charges that JAMA's Executive Deputy Editor threatened Dr. Leo, and its Editor-in-Chief called the dean of Leo's college demanding a retraction.  In a Wall Street Journal report on the "dust up", the editor-in-chief called Dr. Leo a "nobody and a nothing", the Alliance letter says.  

According to the Alliance, medical journal editors have a  responsibility  "to provide an open forum for scientific debate, and to preserve the scientific integrity of the journal and its content by ensuring against concealed conflicts of interest."  The Alliance contends that the JAMA editors not only  "failed to meet this responsibility, they resorted to threatening retribution against a researcher who detected failures in their editing and gatekeeping processes."

The Alliance letter charges that the incident involving Dr. Leo has raised questions about whether drug advertising influences JAMA's publication of biased reports.  The conduct of the JAMA Editor-in-Chief also "touched off an outpouring of 158 angry responses posted on the Wall Street Journal Health blog, the majority posted by physicians, several respondents indicated they are canceling their JAMA subscriptions," the letter claims.

The letter concludes with a call for a public apology to Dr.  Leo by the American Medical Association, the immediate suspension from duty of the two editors involved in the matter, a thorough investigation, and a commitment to reviewing, clarifying and publishing JAMA's editorial policies.

]]> Depression Med Linked to Pediatric Suicide Approved by FDA for Kids http://www.yourlawyer.com/articles/read/16288 Tue, 24 Mar 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16288 Lexapro (escitalopram oxalate) has been approved for major depressive disorder (MDD) in children aged 12 to 17 reports HealthDay News.

According to Forest Laboratories, about two million teenagers in this country have experienced MDD in the past year, said HealthDay News; a fact used to market Lexapro to young patients despite evidence showing that  Lexapro promotes suicidal thoughts in pediatric patients.  The U.S. Justice Department recently charged Forest Labs for such inappropriate marketing to children.  Now, less than one month later, Forest Labs received approval for Lexapro to be prescribed to the very group it was accused of improperly marketing, points out Modern Medicine.

In a prior Wall Street Journal (WSJ) article, the same prosecutors charged Forest Labs with violating anti-kickback laws by paying doctors to prescribe Lexapro to vulnerable, pediatric patients.  The suit also accused Forest Labs of violating the False Claims Act when it marketed the drug and accuses Forest of covering up a medical study that concluded that Lexapro and Celexa—another antidepressant—were not effective medications for children, said WSJ.  An earlier Bloomberg.com article said the complaint charges that Forest was unwavering in its marketing of the drugs.

Knowing that the drugs were ineffective in children and could also cause suicidal thoughts in pediatric patients, Forest went ahead and promoted Lexapro and Celexa for use in children, going so far as to cite a study that was more conducive to its needs, hiding the negative findings.  Meanwhile, the U.S. Food and Drug Administration (FDA) had not approved the drugs for use in children at that time.

Lexapro was approved for adults in 2002 and is one of a class of antidepressants called selective serotonin reuptake inhibitors—or SSRIs.  Lexapro and other similar drugs now include a “black box” warning label indicating that the medications are linked with an increased risk of “suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders,” quoted HealthDay News, adding that those considering Lexapro use in pediatric patients “must balance this risk with the clinical need.”

Reuters said federal prosecutors alleged both Lexapro and Celexa have been inappropriately used to treat pediatric depression and that after a five-year investigation, the U.S. Justice Department accused Forest of urging pediatricians to prescribe the drugs, enticing them with bribes and perks, said Reuters.  The complaint also accused Forest of ignoring a study that revealed that Celexa, which is chemically similar to Lexapro, was ineffective in children and then having its sales staff use a second study that with more positive outcomes for Lexapro’s pediatric use, reported Reuters.

Using the complimentary study, the FDA approved the controversial medication for use in the vulnerable population despite established research to the contrary and that the study used did not indicate the drug’s efficacy; Forest also admitted that there was no clinical proof that Lexapro could control symptoms in teens taking Celexa.  Regardless, the FDA said such “maintenance efficacy” could be “extrapolated” from adult data.

]]> Celexa, Lexapro Promotions Questioned http://www.yourlawyer.com/articles/read/16140 Thu, 26 Feb 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/16140 Lexapro and Celexa were both proven to promote suicidal thoughts in children, Forest Laboratories chose to market its antidepressants to pediatric patients anyway, prosecutors at the U.S. Justice Department have charged.

According to the Wall Street Journal (WSJ),  the same prosecutors have charged that Forest Labs also violated anti-kickback laws by paying doctors to prescribe Lexapro and Celexa to vulnerable, pediatric patients.  A lawsuit filed by the department now  accuses the drug maker  of violating the False Claims Act  when it marketed the drug, The  civil complaint  also accuses Forest of covering up a medical study that concluded that Lexapro and Celexa were not effective medications for children, said WSJ.  The complaint was unsealed in Boston federal court yesterday.

According to Bloomberg.com, the complaint charges that Forest was unwavering in its marketing of the drugs.  Knowing that they were ineffective in children and could also cause suicidal thoughts in pediatric patients, Forest went ahead and promoted Lexapro and Celexa for use in children, going so far as to cite a study that was more conducive to its needs and hiding the negative findings.  Meanwhile, the U.S. Food and Drug Administration (FDA) never approved the drugs for use in children.

According to the DOJ, Forest’s bribes and inappropriate marketing resulted in false claims submission for reimbursement to federal health care programs said the Journal.  Bribes included not just cash payments—falsely described as grants and consulting fees—but pricey meals and other expensive gifts which violated anti-kickback laws, said Bloomberg.  “By knowingly and actively promoting these antidepressants for off-label pediatric use without disclosing the results of the negative pediatric study, and by paying kickbacks, Forest caused false claims to be submitted to federal health care programs,” Massachusetts U.S. Attorney Michael Sullivan said in the complaint, reported Bloomberg.

Now, under the federal False Claims Act, the DOJ is looking for triple the financial damages from Forest in addition to other penalties; the total compensation sought is unknown, said the Journal.  Bloomberg noted that under the Act, the government is eligible to receive treble damages and civil penalties of up to $11,000 per violation.

This case and others may be evidence that the DOJ is making a concerted effort to crack down on the illegal drug marketing practices.  The Journal pointed out that just last week, the DOJ joined a whistle blower lawsuit against Johnson & Johnson  in which the drug maker is charged with illegally marketing its cardiac medication Natrecor.  Also, last month, Pfizer Inc. and Eli Lilly & Company both agreed to payouts in two separate cases involving illegal marketing, said the WSJ.  Pfizer agreed to pay over $2 million in response to charges it illegally promoted it now-withdrawn painkiller Bextra.  Eli Lilly agreed to pay $1.4 billion in fines to settle similar claims  over its antipsychotic Zyprexa.

]]> Antidepressants Linked to Stomach Bleeding http://www.yourlawyer.com/articles/read/14720 Tue, 08 Jul 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14720 Prozac, Forest Laboratories Inc.’s Celexa and Lexapro, GlaxoSmithKline Plc.’s Paxil, and Pfizer Inc.’s Zoloft.

According to Francisco de Abajo, from the Spanish Agency for Medicines and Healthcare Products, these drugs could trigger gastrointestinal bleeding in one out of every 2,000 patients.  The study found that the risk also applies to Wyeth's innovative pill Effexor, but with Effexor, the risk increases to one in 250 patients when aspirin or pain drugs also are taken.  The researchers found that these medicines interfere with platelets, “a critical part of the body's normal clotting process.”  “The risk … should be considered, de Abajo said, adding that 
"The risk … may be much more important in patients," with a history of ulcers or who regularly use medications such as aspirin and pain pills.  The researchers studied the medical records of 1,321 patients with upper gastrointestinal tract bleeding, and compared them with a healthy group of 10,000 people.  Of those with bleeding, 5.3 percent were taking SSRIs as compared with three percent of the healthy group.  Of those who experienced bleeding, about 1.1 percent were taking Effexor, a different type of antidepressant, compared with 0.3 percent among those without an ulcer.

de Abajo suggests that proton pump inhibitors—drugs that suppress the production of acid in the stomach—such as Prevacid, Prilosec, Nexium, and Protonix, could help minimize the bleeding “for those most vulnerable and should be considered.”  AstraZeneca, Plc., the maker of Nexium and Prilosec, helped fund the Spanish study.

Meanwhile, the Food & Drug Administration (FDA) has investigated a suspected link between cardiac trouble and acid-reflux drugs Prilosec and Nexium.  Also, because both drugs are proton-pump inhibitors, they may be overly effective at stopping stomach acid production, raising pneumonia, bone loss risk, and fracture risk, this by over 40 percent in patients on long-term use.

In a study we reported on in February that was conducted by British researchers on the effect of some antidepressants found that they may only really be truly effective in the most severely depressed of patients.  The study also found that these antidepressant medications actually work no better than placebos in many patients taking them and that the patients fared the same whether on a placebo or on one of the antidepressant medications represented in the study:  Prozac, Effexor, and Paxil.

Meanwhile, there have been warnings that antidepressants might increase suicidal behavior in youth.  U.S. and European regulators sent out a series of public health warnings in 2003 after clinical trials showed the drugs increased the risk of suicidal thoughts and behaviors in children and teens.  In 2004, the FDA issued its strongest warning—a black box—on all antidepressant use in children and teens to draw attention to these medications’ possible risks.

]]> 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.]]> WARNING: Withdrawal Reactions With Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants http://www.yourlawyer.com/articles/read/10991 Thu, 01 Dec 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/10991
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.
]]> FDA Rejects Expanding Lexapro Marketing http://www.yourlawyer.com/articles/read/9526 Wed, 30 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9526
Lexapro, which is Forest's bestselling drug, is approved for the initial treatment and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults. For the three months ended Dec. 31, Lexapro produced sales of $427 million, or 54% of corporate revenue.

Although federal law allows doctors to prescribe an FDA-approved drug for any use, companies can market the drug only for specific indications endorsed by the FDA. That's why companies seek FDA approval for multiple uses for a single drug.

This is the second setback for Lexapro in four weeks. The FDA also rejected Forest's application to have the drug marketed for treating panic disorder, which is characterized by recurrent panic attacks. Social anxiety disorder, also known as social phobia, refers to an extreme fear of embarrassment in social situations.

In regular trading Wednesday, Forest's stock closed at $37.05, up 30 cents. But in after-hours trading, the stock was down 76 cents.

Forest says it's "not approvable letter" from the FDA noted that although one of two clinical trials supported the application, the FDA "raised questions related to the reliability of patient data at one study center in the second pivotal study."

Once the FDA eliminated data from the one study center, test results failed to achieve statistical significance. Forest says it is reviewing the FDA's analysis "and will determine the appropriate next steps in the coming months."]]> 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. ]]> FDA Admits Drugs' Risks http://www.yourlawyer.com/articles/read/8531 Tue, 14 Sep 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8531
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.]]> Lexapro Suicide SSRI Side Effects Lawsuit http://www.yourlawyer.com/topics/overview/lexapro Tue, 14 Sep 2004 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/lexapro DOWNLOAD OUR LEXAPRO INFORMATION PACKAGE

Injured by Lexapro?

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. In the United States, use of antidepressants for patients under 18 years has not been approved by FDA, with the exception of Prozac. This means that both the healthcare professional who prescribes or dispenses these drugs for children and adolescents and the pharmaceutical company that promotes this "off-label" (unapproved) use knowingly take a risk with the patient's safety.  Antidepressants are widely suspected of contributing to suicidal and/or violent behaviors, especially in children. This point of view has recently been adopted by the U.S. Food and Drug Administration (FDA), somewhat more slowly than its British counterpart, the Medicines Control Agency.

Newer anti-depressants such as Lexapro, known as selective serotonin reuptake inhibitors (SSRIs), have come under recent scrutiny. Lexapro is prescribed to treat major depression. In March, the Food and Drug Administration asked the makers of SSRIs to include warnings that children and adults might become more depressed or suicidal while taking these drugs, and that close supervision, particularly at the start of treatment, is required.

Forest Pharmaceutical, the manufacturer of Lexapro, continues to downplay the drug's dangers.

Lexapro side effects include: Insomnia, Diarrhea, Dry Mouth, Somnolence (sleepiness or drowsiness), Dizziness, Increased Sweating, Constipation, Fatigue, Indigestion, Ejaculation Disorder (male), Decreased Libido (decreased sex drive) (both male and female), Impotence (male), Influenza-Like Symptoms (flu-like symptoms), Appetite Decreased, Rhinitis (runny nose), Sinusitis (inflammation of the sinuses), Possible Impairment of Fertility (inability to get pregnant), Danger of Birth Defects (Pregnant Females), Passing of Drug to Nursing Babies, Danger to Patients With History of Mania, Danger to Patients with History of Seizures, Danger to Patients with Suicidal Tendencies (note: Drugs such as Lexapro have been present in numerous suicide cases, although drug companies have denied the drugs as causes). Additional side effects include: Interference with operation of machinery including automobiles, Impairment of Judgment, Priapism (males) (Persistent, usually painful erection of the penis, especially as a consequence of disease and not related to sexual arousal).

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