MEDICATIONS: FDA WARNING ON ANTIDEPRESSANTS CHALLENGED BY LONG-TERM, POPULATION-BASED "SUICIDE RISK DURING ANTIDEPRESSANT TREATMENT" STUDY

MEDICATIONS: FDA WARNING ON ANTIDEPRESSANTS CHALLENGED BY LONG-TERM, POPULATION-BASED "SUICIDE RISK DURING ANTIDEPRESSANT TREATMENT" STUDY

Jan. 24, 2005 — A 10-year population-based study in the January 2006 edition of the American Journal of Psychiatry (AJP), a monthly psychiatric journal of the American Psychiatric Association (APA), challenges the U.S. Food and Drug Administration (FDA) warning that that suicidal behavior may emerge after treatment is begun with antidepressant medications.

The study, "Suicide Risk During Antidepressant Treatment," led by Gregory E. Simon, M.D., M.P.H., investigates 65,103 patients who filled prescriptions for antidepressants in a large health plan between 1992 and 2003. The number of suicide attempts fell by 60 percent in adults during the month after antidepressant treatment began, and it declined further in the subsequent five months.

Questions about antidepressants and suicidality have focused particularly on adolescents. The investigators found a higher rate of suicide attempts among adolescents (314 per 100,000) than among adults (78 per 100,000) in the first six months of antidepressant treatment. But, as for adults, the rate was highest in the month before treatment and declined by about 60 percent after treatment began.

"This study directly addresses the question of whether newer antidepressants increase or decrease suicide risk for adolescents. The answer is that suicide risk is decreased and that the positive effects exceed those of earlier generation drugs," said Robert Freedman, M.D., AJP editor-in-chief.

"The use of the newer drugs had decreased in response to concerns about suicide risk. Dr. Simon's study provides evidence to the contrary. The newer drugs decrease suicide risk significantly."

The findings also call into question the FDA focus on 10 newer antidepressant drugs. When suicide attempts were compared in patients taking these drugs and in patients taking older antidepressants, an increase in suicide attempts was seen only for the older drugs. For the newer drugs, the rate dropped dramatically in the first month after antidepressants were prescribed.

"This is a very useful analysis for shedding light on the risk of suicide associated with antidepressants," said Darrel A. Regier, M.D., M.P.H., director of the APA's Division of Research. "It is particularly timely as the FDA continues to study the spontaneous reports of "suicidality" among adults on antidepressants."

A large-scale study does not exclude the possibility that certain vulnerable individuals will experience increased suicidal behavior, but these findings do suggest that it is not common in either adults or adolescents and that it is less likely with the newer antidepressants.

The "Suicide Risk During Antidepressant Treatment" study is supported by the National Institute of Mental Health.

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