BETHESDA, Md. — Top Food and Drug Administration officials said publicly for the first time Monday that scientific trials of frequently prescribed antidepressants have demonstrated that children who took the medications faced an increased risk of suicide.
Testifying before two FDA advisory committees, the officials said that a recent study contracted by the FDA and conducted by Columbia University confirmed the findings of an internal analysis early this year: In clinical trials, the drugs almost doubled the incidence of suicidal behavior in children.
"What's striking about it is the consistency," said Dr. Robert Temple, director of the FDA's office of drug evaluation, referring to the medications' effects on young people.
More than 4,000 children ages 6 to 18 participated in the clinical trials. None of the children killed themselves, although hundreds experienced suicidal behavior or thoughts.
The agency, under mounting criticism for its approach to regulating antidepressants for children, is seeking advice from the two committees on the need for further regulation. The committees are expected to announce their suggestions today at the culmination of a two-day meeting.
Concerns about a possible link between the drugs and suicide were raised in the media and by some psychiatrists in 1990. The FDA convened an advisory panel on the topic but issued no warnings. Anecdotal evidence of such a link continued to accumulate, and last December the British counterpart of the FDA effectively prohibited physicians from prescribing a range of antidepressants to children, citing an increased risk of suicide.
In March, after hearings where parents told of the effects these drugs had on their children, the FDA ordered manufacturers of 10 frequently prescribed antidepressants -- Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Effexor, Wellbutrin, Serzone and Remeron -- to include warnings about an increased risk of deepening depression or even suicide on product labels and urged patients and their families to report any changes in behavior to their doctors.
Members of Congress from both parties have joined parents in criticizing the FDA for suppressing the results of the internal study, which showed a clear link between the drugs and suicidal behavior in youths. That study became public after it was leaked to the news media.
