Antidepressant Suicidality Class Risk Will Be Reviewed By Advisory Committees
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA releases analysis of pediatric suicidality data for joint meeting of Psychopharmacologic Drugs and Pediatric Advisory Committees. The analysis could result in label changes for antidepressants, FDA Talk Paper says.
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FDA will ask its Psychopharmacologic Drugs and Pediatric Advisory Committees to determine if there is an antidepressant class risk for suicidality based on agency analysis. Draft questions for the advisory committees' Sept. 13-14 meeting include, "do the suicidality data from these trials support the conclusion that any or all of these drugs increase the risk of suicidality in pediatric patients?" an Aug. 20 FDA 1 Talk Paper states. "Please discuss, for example, whether the increased risk applies to all antidepressants, only certain classes of antidepressants, or only certain antidepressants." FDA's analysis of pediatric suicidality data could result in label changes for antidepressants. "Although specific new labeling language has yet to be developed, FDA will assure that the labels of the antidepressants used in pediatric patients reflect the most recent information obtained from these studies and analyses," the Talk Paper states. FDA is convening the advisory committees to review the agency analysis, co-developed by Columbia University, of the association of antidepressants and pediatric suicidality (2 (Also see "FDA Analysis Of Antidepressant Pediatric Suicidality Data To Be Reviewed Sept. 13-14" - Pink Sheet, 2 Aug, 2004.)). The Sept. 13-14 meeting serves as a follow-up to a Feb. 2 meeting during which advisory committee members expressed concern about the high degree of variability and lack of categorization of events believed to be suicide related (3 (Also see "Antidepressant Warnings On Pediatric Suicide Need Immediate Strengthening, Cmte. Says" - Pink Sheet, 3 Feb, 2004.)). FDA also is asking the advisory committees to comment on FDA's "approach to classification of the possible cases of suicidality (suicidal thinking and/or behaviors) and...analyses of the resulting data from the 23 pediatric trials involving 9 antidepressant drugs." FDA's handling of information showing a possible link between antidepressants and suicidality has been the subject of congressional investigations. A House Energy & Commerce/Oversight Subcommittee hearing on the topic is scheduled for Sept. 9 (4 (Also see "House Antidepressant Hearing Rescheduled For Sept. 9" - Pink Sheet, 13 Aug, 2004.)). In March, FDA requested that labeling for 10 antidepressants include a warning recommending close monitoring of adult and pediatric patients for suicidal behavior (5 (Also see "FDA Requests Antidepressant Labeling Add Warning On Suicidality" - Pink Sheet, 22 Mar, 2004.)). Lilly and Pfizer have submitted briefing documents for the joint advisory committee meeting. Analyses of Prozac pediatric data, submitted to FDA in 2003, "do not support an association of suicide-related events with fluoxetine treatment compared with placebo treatment in pediatric patients," 6 Lilly's briefing documents say. Pfizer analyses of Zoloft pediatric studies drew similar conclusions. "A comprehensive evaluation conducted by Pfizer of the Zoloft placebo-controlled trials shows that the risk of suicide-related behavior in children and adolescents treated with Zoloft in clinical trials of [major depressive disorder] is no greater than that with placebo," 7 Pfizer's briefing documents say. An Aug. 18 editorial in the Journal of the American Medical Association suggests a clinical trial database is necessary to determine whether fluoxetine (Prozac) is the only effective SSRI in treating major depressive disorder in a pediatric population. - Adam Eckstein |