Labeling for antidepressants should be revised to note that the risk of antidepressant-induced suicidality does not extend to adults, FDA's Psychopharmacologic Drugs Advisory Committee concluded during its Dec. 13 review of FDA's meta-analysis of antidepressant experience.

Committee members uniformly agreed about the need to alter antidepressant class labeling to reflect the data from FDA's findings on the risk of suicidality in adults - although the committee did not come to consensus on the appropriate phrasing for that information.

FDA's analysis, which the committee found acceptable, determined that the risk of suicidal ideation and behavior that had previously been detected in pediatric populations did extend into young adults, but that the risk was not seen in patients above 25 years of age and a protective effect seemed to appear in patients above 30 and particularly above 65 years of age (¹ Also see "Antidepressant Adult Suicidality Labeling To Be Presented For Advisory Committee Review" - Pink Sheet, 12 December, 2006.).

Given the early and consistent consensus on the results of the meta-analysis and the need to include the data in labeling, much of the committee's discussion focused on the impact that labeling changes would have on treatment of depression.

The negative impact that the existing pediatric "black box" warning has had on prescribing patterns, an effect that FDA acknowledged, was a significant concern for the committee. Several committee members suggested that language could be added to labeling about the importance of treating depression.

An unanticipated outcome of the meeting was the suggestion that FDA reconsider whether the information on pediatric suicidality should be removed from the black box and perhaps presented in labeling in a different way.

Assuming that a black box remained, the committee voted 8 to 2 that the new data on adult suicidality should be added to the box, with the caveat that a statement also be added about the risk of suicidality if depression is left untreated.

- Mary Jo Laffler (m.laffler@elsevier.com)

FDA Should Add Age Modification To Antidepressant Suicidality Warning, Committee Says

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