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Injured by Prozac?

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. Reports of suicidal behavior in children and adolescents taking Eli Lilly & Co.'s Prozac (Generic: Fluoxetine) are becoming widespread. Prozac was introduced in the U.S. in 1988 and is the only antidepressant certified as safe for children. Robert Temple, director of the Office of Drug Evaluation at the FDA, said that a large new study added to previous research on Prozac and showed that kids taking the drug have about a 50 percent higher risk of suicidal thoughts and suicide attempts.  Temple spoke at the first day of hearings on potential label changes for antidepressants taken by more than a million children and teenagers.

Following a February 2004 hearing, the FDA in March asked drug companies to relabel 10 antidepressants, warning that young patients should be watched for worsening depression and anxiety. Critics at the time thought the move came too late, considering that, in December, British drug regulators had advised doctors to prescribe only Prozac for depressed kids. Other major antidepressants prescribed for kids already have been found to raise the risk of suicidal behavior. Prozac had been an exception. "What's interesting and persuasive is that these studies now all lean the same way," Temple says.

Dozens of parents testified at the hearing that antidepressants had caused their children to kill themselves or others. Their claims were "passionate and plausible," says psychiatrist Wayne Goodman, chairman of the FDA advisory panel. On average, antidepressants taken by kids will cause an extra 2 percent to 3 percent to have increased suicidal thoughts, the independent experts, working with Columbia University, found.

Relative risks of suicidal behavior were highest among youths taking Luvox, Effexor and Paxil and lower among youths taking Celexa, Zoloft and Prozac. Two FDA advisory panels are considering whether agency action including stronger warning labels is needed on nine antidepressants linked to heightened suicidal tendencies among children.

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