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Children and Youth

Drugs (Pharmaceuticals)

Suicides and Suicide Attempts

Depression (Mental)

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F.D.A. Panel Urges Stronger Warning on Antidepressants

Published: September 15, 2004

(Page 2 of 2)

Committee members pushed for the patient attachment after hearing dozens of bereaved relatives describe physicians who they said had cavalierly prescribed antidepressants to children for a whole range of conditions that the drugs were never intended to treat and then failed to warn patients about the risks.

"If I heard nothing else from the public, it was that they want to be warned," said Jean Bronstein, a nurse from Sunnyvale, Calif., who serves as a consumer representative to the advisory committee.


Advocates who have argued for years that antidepressants are over-used and often dangerous said that they were pleased with the committee's recommendations.

"That they voted for a black box is more than I ever would have hoped for," said Sara Bostock, 58, of Atherton, Calif. Ms. Bostock's 25-year-old daughter, Cecily, stabbed herself in the throat after being prescribed an antidepressant.

The members of the committee who opposed the addition of black-box warnings to the drugs' physician-information sheet said they did so because they feared such warnings would discourage physicians from treating depressed youngsters.

Dr. Matthew V. Rudorfer, a panel member from the National Institute of Mental Health, said that 15 percent of teenagers with untreated depression commit suicide - a much greater risk than that presented by the drugs themselves, he said. And another panelist from the institute, Dr. Daniel Pine, noted that one-on-one talk therapy has been found in a landmark study to work no better in treating depression in teenagers and children than placebos. In that study, published this summer, Prozac was more effective by some measures than either talk therapy or placebos.

To some, such results, however meager, mean that these drugs can help. But others point out that most other studies, many of them smaller, have shown that the drugs do not work.

In comments after the hearing, Dr. Temple of the F.D.A. said he hoped that the committee's decision would help dim the controversy that has swirled around the agency for much of the year.

The agency held a similar hearing in February in which top agency officials treated with skepticism findings from numerous clinical trials that the drugs may lead some patients to become acutely suicidal.

Weeks after the hearing, leaked documents showed that a top safety reviewer at the agency, Dr. Andrew Mosholder, had concluded that the drugs did cause some patients to become suicidal and that the drugs' risks outweighed their benefits in children and teenagers. Top officials were forced to admit that Dr. Mosholder's testimony at the February meeting was canceled because of his views.

Senate and House committees initiated investigations. More leaks ensued. Agency officials insisted that they simply needed time to undertake a more thorough review of the studies. That review was completed last month with conclusions nearly identical to Dr. Mosholder's original analysis.

In comments after the meeting, Dr. Temple said that the agency, which has already said it will consider label changes for antidepressants, said it would decide on those changes within a few months.

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