FDA Advisory Committee

FDA’s analysis of independently reviewed pediatric suicidality data for antidepressants will be discussed Sept. 13 & 14 during a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the newly formed Pediatric Advisory Committee.

The meeting is being held as a follow-up to a Feb. 2 meeting where advisory committee members expressed concern about the high degree of variability and lack of categorization of events believed to be suicide related.

FDA’s preliminary review of over 4,000 pediatric patients from clinical trials of several antidepressants identified 109 cases as “possibly suicide related.”

Since the Feb. 2 meeting, “experts in pediatric suicidality, assembled by Columbia University, have independently classified these reported events, and FDA has conducted an analysis of these data,” a Federal Register notice slated for publication Aug. 4 states.

The Columbia group employed a standardized methodology to categorize events into “suicidal,” “non-suicidal,” and “indeterminate.” The suicidal category has three subdivisions: “suicide attempt,” “suicidal ideation,” and “suicidal behavior without injury.”

“The committees will consider the results of FDA’s analysis of these independently classified events and will consider what further regulatory action may be needed with regard to the clinical use of these products in pediatric patients,” the Federal Register notice reports.

Also on the agenda for the two-day meeting is discussion of further research needed to address questions of pediatric suicidality with antidepressant use.

FDA’s conduct with regard to the pediatric data remains under investigation by the Senate Finance Committee. The investigation was recently expanded with an inquiry regarding the relationship between CDER’s Office of New Drugs and Office of Drug Safety.

In the wake of the investigation, eight out of 10 of the selective serotonin reuptake inhibitors have added class warnings on suicidality to labeling. Pfizer is negotiating language for Zoloft; Solvay’s Luvox was withdrawn in 2002.

The Sept. 13-14 meeting will be the first meeting of the full Pediatric Advisory Committee. The Pediatric Ethics Subcommittee will meet Sept. 10 to discuss a study protocol for dextroamphetamine; a full committee review will follow Sept. 15.

To watch a webcast of this meeting, click the button below. To arrange for live videoconferencing, or to order videotapes & DVDs, email webcasthelp@elsevier.com or call 800-627-8171.