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FDA Study Confirms Antidepressant Risks

Drugs Linked to More Suicides Among Children, Unpublished Analysis Says

By Shankar Vedantam
Washington Post Staff Writer
Tuesday, August 10, 2004; Page A06

Six months after the Food and Drug Administration withheld an internal finding that antidepressant medications were associated with an increased risk of suicide among children, a second staff analysis has arrived at the same conclusion.

The agency has not publicly disclosed either report, despite growing pressure from critics and Congress. Agency officials say they do not plan to discuss the data until a scheduled meeting in September, which would come nine months after British authorities warned physicians not to prescribe Paxil, Zoloft, Celexa and similar drugs to depressed children, and more than a year after the first concerns emerged.

The new analysis has renewed the complaints of critics that the FDA is moving too slowly to address the concerns about suicide.

One leading expert who reviewed the two internal analyses said they had changed his thinking about the risks. "I didn't have access to the proprietary data" reflected in the FDA analyses, said Steven Hyman, former director of the National Institute of Mental Health, who initially thought British regulators had overreacted. Hyman reviewed the analyses at the request of The Washington Post.

"Now I would say from the data in front of me, with the exception of Prozac, there is concern about the risk-benefit ratio of antidepressants in children," Hyman said.

FDA officials have declined to release the new analysis, first reported by the Wall Street Journal, and said they were still reviewing the information. "It would be premature to discuss any conclusions and results," said spokeswoman Kathleen Quinn. "Other people are going to have an opinion about it, but we are still reviewing it."

The new analysis comes amid growing concerns that crucial information about the safety and effectiveness of the drugs has been withheld from public scrutiny. Two-thirds of the trials conducted by drug manufacturers found that the medications performed no better than sugar pills, but details of the negative trials were kept from doctors and parents.

Joseph Glenmullen, a Harvard psychiatrist and author of "Prozac Backlash," a book about the side effects of antidepressants, said one company, Wyeth, had itself warned doctors not to prescribe its antidepressant Effexor for children: "The companies are coming to this conclusion, and the British came to this conclusion, and the Canadians and the rest of Europe and the FDA's own reviewer have come to this conclusion; why have they dragged their feet for over a year?"

The new "interim review" by FDA medical reviewer Tarek A. Hammad is a compilation of data with no narrative or interpretation. But both Hyman and Glenmullen said it showed an increased risk for children taking the drugs similar to that found in February by another FDA scientist, Andrew Mosholder.

Hammad's review found that compared with depressed children who got placebos, children who got antidepressants had 1.78 times the risk of making a suicide attempt or "making preparatory actions towards imminent suicidal behavior."

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