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FDA Admits Drugs' Risks


Sep 14, 2004 | Los Angeles Times

Top Food and Drug Administration officials said publicly for the first time Monday that scientific trials of frequently prescribed antidepressants have powerfully demonstrated that children who took the medications faced an increased risk of suicide.

Testifying before two FDA advisory committees, the officials said 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. Of the 40,000 adults who have participated in clinical trials for the antidepressants, 30 have committed suicide, according to the FDA.

The agency, under mounting criticism for its approach to regulating antidepressants for children, is seeking advice from the two committees on the necessity of further regulation. The committees are expected to announce their suggested regulatory approach 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 in 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 youth suicide. That study became public after it was leaked to the news media.

But Temple said he was not sorry for waiting for the Columbia study before concluding that the data suggested a clear link between the drugs and suicidal behavior among children and teens.

It would be dangerous, he said, to prematurely rule out these drugs as possible treatment for childhood depression because there are few medical remedies available for the illness. Depression plays a significant role in suicide, the third-leading cause of death in teens.

``We've thought all along, it is extremely important to get as right an answer on this as we can,'' Temple told reporters.

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