Prozac, the only antidepressant certified as safe for children, may make kids more suicidal, according to evidence out Monday.
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 than those getting placebos, 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. The discussion continues today, and an advisory committee could end the day by asking for tougher warning labels on all antidepressants taken by kids. The FDA typically follows the advice of its advisory committees.
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.
So far, only Prozac has been found to be effective in children and teens, although the other drugs, approved for adults, are prescribed to children as an off-label use.
There were no suicides in the antidepressant studies of about 4,600 children. The increased risk for suicidal behavior is small: About two to three kids in a group of 100 become more suicidal because they’re on antidepressants, says Tarek Hammad, medical reviewer for the FDA.
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.
But other parents and psychiatrists said the popular pills, such as Zoloft and Celexa, are saving lives every day.
Drug company spokesmen argued that antidepressants are safe. Company studies show most suicide attempts by children on Zoloft are linked to stress, not to taking the drug, says Steve Romano of Pfizer Inc., which makes Zoloft.
Although antidepressants seem to generate more suicidal behavior, “we can’t forget all those who are protected from suicide by treatment,” Goodman says.
There may be a group of kids who are particularly vulnerable to dangerous effects, but the limited studies so far don’t suggest how they can be identified, FDA officials say.