Prozac (generic name: fluoxetine hydrochloride) is an antidepressant manufactured by Eli Lilly and Company. Confidential Eli Lilly documents obtained by the British Medical Journal suggest that the company was aware that Prozac was linked to troubling side effects as far back as 1988, the same year the drug was introduced to the U.S. market.
The discovery was reported in the January 1, 2005 issue of the British Medical Journal and the papers were turned over to the U.S. Food and Drug Administration (FDA). Amid the pile of internal reviews and memos, according to the journal, is a document dated November 1988 that reports Prozac had caused behavioral problems, including agitation and panic attacks, in clinical trials.
Prozac, the only antidepressant certified as safe for children, may make kids more suicidal, according to new evidence. A large new study added to previous research on Prozac shows that kids taking the drug have about a 50 percent higher risk of suicidal thoughts and suicide attempts, says Robert Temple, director of the Office of Drug Evaluation at the FDA.
Temple spoke at the first day of hearings on potential label changes for antidepressants taken by more than a million children and teenagers. Following the hearing, the FDA asked drug companies to relabel 10 antidepressants, warning that young patients should be watched for worsening depression and anxiety. Critics at the time derided that move as "too little, too late," considering that, only a few months prior, British drug regulators had advised doctors to prescribe only Prozac for depressed kids. Other major antidepressants prescribed for kids already had been found to raise the risk of suicidal behavior, with Prozac as the 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, chair of the FDA advisory panel. On average, antidepressants taken by kids will cause an extra 2 to 3 percent to have increased suicidal thoughts, found the independent experts working with Columbia University.
Relative risk of suicidal behavior was 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 for nine antidepressants linked to heightened suicidal tendencies among children.
