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Suicide Risk to Children Affirmed

September 14, 2004|Elizabeth Shogren | Times Staff Writer

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.

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

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.

Fluoxetine hydrochloride, marketed by Eli Lilly & Co. as Prozac, is the only antidepressant approved by the FDA for use in children, because it meets the agency's standard of effectiveness in clinical trials. Doctors regularly prescribe several of the other drugs to young patients, however.

Dr. Tarek Hammad, the FDA's senior medical reviewer, said that 2% to 3% of the children treated with the antidepressants in the most recent study experienced increased suicidal behavior or thought.

The FDA analyzed 26 trials of nine antidepressants. (Lexapro was not included in these trials.) Data from 25 trials conducted by drug manufacturers were reexamined by Columbia scientists, while independent researchers conducted the 26th trial.

Dr. Andrew Mosholder, the FDA researcher who produced the earlier internal analysis showing a connection between the drugs and suicidal behavior in children, said the new report "reproduced" his findings. Mosholder's superiors had prohibited him from presenting his findings at a February FDA advisory committee meeting on the same topic.

After a morning of dispassionate scientific presentations, the committee heard from family members of children who committed acts of violence, including suicide, while taking the drugs. In emotional appeals, the relatives urged the FDA to ban the drugs.

"The senior leadership at FDA drag their feet and make Orwellian statements such as 'Just because these drugs have not been proven to be effective does not necessarily mean they're ineffective,' " said Thomas Woodward, a businessman from North Wales, Pa., whose 17-year-old daughter killed herself after taking Zoloft for seven days. The FDA officials "know the truth and therefore have blood on their hands," he said.

Raul Laguerre of Newburgh, N.Y., said his son may spend most of his life in prison because of a violent act he committed while taking one of the drugs.

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