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FDA advisers: Kids' antidepressants need warnings

Posted - Sep. 15, 2004 at 6:40 a.m.



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BETHESDA, Md. -- All antidepressants should carry a ''black box'' warning on the label saying that the pills can cause suicidal behavior in children, scientific advisers told the Food and Drug Administration on Tuesday.

The black box warning is the strongest warning label and is reserved for deadly drugs. The panel also said the FDA should require that fact sheets warning of the suicide risk should be given to everyone picking up children's prescriptions for antidepressants.

The recommendations capped a two-day hearing here on the issue. The FDA usually does what its scientific advisers suggest -- but not always. A decision on the recommendations is expected within a few months, said Robert Temple of the FDA's Office of Drug Evaluation.

The panel decided against banning all antidepressants but Prozac for use in children, as British drug regulators did in December. The research is too limited for an outright ban, they said.

Prozac is the only antidepressant approved for use in children with major depression. But other drugs, such as Celexa and Zoloft, can be prescribed legally for children as an off-label use.

Concerns about suicidal behavior in pediatric studies of Paxil, one of the antidepressants, prompted the FDA last year to ask for more analysis on similar drugs. A preliminary report in February suggested there might be more suicidal behavior in children who were taking the pills. This led the FDA to request stronger warning labels on 10 antidepressants in March.

But the new ''black box'' warnings would be much stronger than those requested in March, which only told doctors to monitor patients for worsening depression and anxiety. The new warnings will say that antidepressants cause more suicidal behavior, Temple said. About two to three children in a group of 100 become more suicidal because they're on antidepressants, FDA officials said.

If the FDA follows its panel's advice, the black box will go on older antidepressants, as well as those just coming to market, such as Cymbalta. If there's a black box, it also may include the fact that studies done on many of the antidepressants have found that they don't work in young patients, Temple said.

But some advisory panel members worried that the black box warning may stop the average pediatrician and family doctor -- who prescribe most antidepressants for children -- from prescribing the pills. They worry that a black box warning may result in many mentally ill children not getting treated.

Requiring a box also could deal a financial blow to drug companies. The box has to be displayed prominently in all advertisements, Temple said.

Drug company spokesmen defended their products as safe during the FDA hearings.

In research on Celexa, one of the antidepressants studied, children whose depression worsened typically were ''poor responders,'' said Jeffrey Jonas for Forest Laboratories, maker of Celexa. The drug didn't work on them, and that's why they got worse, but it did not cause their suicidal behavior, Jonas told the FDA.

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© Copyright 2004 USA TODAY, a division of Gannett Co. Inc.

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