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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 and 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.
Washington Post August 10, 2004