Prozac

New evidence has surfaced showing that Eli Lilly & Co. knew Prozac was linked to suicidal behavior and violence as early as 1988. Confidential Eli Lilly & Co. documents obtained by the British Medical Journal suggest that the company was aware that its antidepressant 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. The papers have been turned over to the U.S. Food and Drug Administration. Amid the pile of internal reviews and memos, according to the journal, is a document dated November 1988 that reports Prozac (fluoxetine) 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 Food and Drug Administration.

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 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 derided that move as "too little, 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.

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