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 Sept. 13-14 joint 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 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 is convening the committees to review an agency meta-analysis, co-developed by Columbia University, of the association of antidepressants and pediatric suicidality.

Results showed a statistically significant link between suicidality and pediatric antidepressant drug use. However, the data also found a decrease (from 1.89 to 1.78) in overall suicidality risk.

Further analyses using the Columbia data set should be conducted to examine discontinuation-related events and events resulting in psychiatric inpatient hospitalization, an FDA epidemiologist recommended in an Aug. 16 memo.

FDA is also interested in the agency?s definitions of suicidality in the previous analyses. FDA is asking the committees to comment on FDA?s ?approach to classification of the possible cases of suicidality? and resulting analyses.

The Aug. 20 Talk Paper suggests FDA?s analyses 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.?

Lilly and Pfizer have submitted briefing documents for the 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,? Lilly's briefing documents state. Pfizer analyses of Zoloft pediatric studies drew similar conclusions.

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. The Pediatric Ethics Subcommittee will meet Sept. 10 to discuss a study protocol for dextroamphetamine; a full committee review will follow Sept. 15.

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