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New Antidepressant Labeling Proposed by FDA

Strong warnings about increased risk of suicide should be extended to include young adults 18 to 24, according to an FDA advisory panel. Currently, warnings only cover teens.

This recommendation came as a result of an FDA review of 372 studies conducted about 11 drugs including Prozac, Zoloft, Lexapro, and Paxil.

Analysis of the combined studies showed a small but significant elevation in risk to young adults - 2 percent reported thoughts of suicide or suicide attempts when on a placebo, compared to 4 percent on antidepressants.

This doubling in risk is "about as unequivocal a result as you can get,” said Dr. Marc Stone, a senior F.D.A. reviewer and an author of the report. "We can't ignore it."

Antidepressents have carried a "black box warning" about the increased risk of suicide for teens since 2004. This warning, located in a black-bordered box above the prescribing information, is the strongest that the FDA can require. Some doctors are worried that including adolescents in this warning will induce a "black-box panic" that could discourage people who need these medications from taking them.

“We’re talking about a devastating, chronic and recurrent disorder, and a black-box warning may serve as another barrier to care that people need,” said Dr. Carol Rabinowitz, president-elect of the American Psychiatric Association. "There is a danger when we paint a medicine as so scary or so potentially dangerous that people avoid it."

Dr. Rabinowitz continued, "Untreated depression causes more loss of life than any of the approved treatments. A black box for adults creates a fear mentality, not only in patients but in doctors...It can limit access to needed care."

Despite such concerns, the committee members are taking the results of these studies very seriously. Remarked Daniel Pine, chief of child and adolescent research at the National Institute of Mental Health and the panel's chairman, "The data are really pretty clear to me and to all the committee members. We need to look at the is issue pretty carefully and the public needs to know more."
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