FDA urges closer monitoring of patients taking antidepressants.

The U.S. Food and Drug Administration (FDA) is cautioning physicians, families, and caretakers to watch closely for signs of suicide or increasing depression among individuals taking antidepressant medications, especially at the beginning of treatment or when dosage levels change.

The agency has asked the manufacturers of 10 leading antidepressants to revise their labels to include stronger language about the need to monitor patients for the worsening of depression and the emergence of suicidal thoughts, regardless of whether such symptoms appear to be related to the medications. The agency also has advised that patients be observed for certain behaviors associated with the drugs, including anxiety, agitation, insomnia, irritability, hostility, severe restlessness, and mania.

The FDA stopped short of linking antidepressants directly to suicide, noting that "it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior." Last year, reports from study trials on some popular antidepressants appeared to suggest an increased risk of suicidal thoughts and actions in children, though none of the patients in the study trials committed suicide and careful scrutiny of the study trial records failed to show conclusively whether certain behaviors observed in the study represented actual suicide attempts or simply injurious behavior.

The FDA's action may prompt physicians, especially those without training in psychiatry, to become more wary of prescribing antidepressants or to recommend smaller doses. It may also boost the popularity of other treatments, such as psychotherapy Numerous studies suggest that depression relapse rates are lower among patients who complete a program of psychotherapy than among patients who take antidepressant drugs.