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Injured by an Antidepressant?

Parker & Waichman, LLP filed the first Prozac suicide lawsuit in the United States in 1990 and has been representing victims of antidepressant side effects for 15 years.

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 October 2004, the FDA announced that it would require all antidepressant drug manufacturers to revise labelling to include a boxed warning about the risk of suicidal thinking and behavior in adolescents and children taking the drugs.  The Agency also announced that it would require health care providers to be notified of suicidality, and patients to receive MedGuides warning them of the risks associated with taking the medications.  The advisory came after the FDA reviewed 24 trials of over 4400 patients. These trials showed that there was twice the risk of suicidality during the first few months of treatment (4%)  in those receiving antidepressants than placebo (2%).

The antidepressants affected by the new expanded warning include:

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 FDA has been criticized as being slow in its acknowledgement of the antidepressant-suicide link.  A particularly worrisome group of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs) has been increasingly prescribed to children and adolescents.  A new study shows a fourfold increase in nonfatal suicidal behavior during the first nine days of treatment with two SSRIs (Prozac and Paxil). This risk remains three times higher during days 10-29 of treatment than after 90 days of treatment.  Fatal suicide is 38 times more likely during the first nine days of treatment. Recent reports have shown that the newer SSRI antidepressants may increase suicide risk in teens and even in adults. 

The following drugs are in the SSRI family of antidepressants:  Prozac, Seromex, Seronil, Fontex, Paxil, Seroxat, Opitar, Aropax, Celexa, Cipramil, Emocal, Sepram, Luvox, Fevarin, Lexapro, Wellbutrin, Effexor, and Zoloft.  The only SSRI drug approved for the treatment of depression in children and adolescents is Prozac, which was approved for children more than 15 years after its initial approval in 1987.  The other antidepressants prescribed to children and teenagers are all prescribed off-label.  Over 11 million antidepressant prescriptions are written for children and teenagers each year.  One theory about suicidal behavior involves a side effect of SSRIs called akathisia. Akathisia is a restless agitation ranging from jitteriness to a sensation described by "jumping out of one’s skin." Patients become anxious, agitated, terrified, unable to sleep at night and restless.  Some researchers and physicians believe that akathisia is the principal trigger for impulsive violence in some people taking SSRIs.

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 became suicidal after taking an antidepressant, contact Parker & Waichman, LLP today for a free consultation about your potential case.