FDA's Psychopharmacologic Drugs Advisory Committee will discuss the possibility of a differential risk of antidepressant-induced suicidality across the age spectrum during its review of FDA's meta-analysis on drug-related suicidality in adults.

The advisory committee meets Dec. 13 in Silver Spring, Md. to consider the results of FDA's meta-analysis of suicidality data from adult antidepressant trials and will outline plans for potential labeling modifications based on the findings.

Overall, the agency concluded that unlike pediatric populations, antidepressants do not appear connected to suicidality in adults. In briefing material for the meeting, Psychiatry Drug Products Division Director Thomas Laughren concluded that "the pooled estimates of studies of the adult population support the null hypothesis of no treatment effect on suicidality."

"The net effect appears to be neutral on suicidal behavior but possibly protective for suicidality for adults between the ages of 25 and 64 and to reduce the risk of both suicidality and suicidal behavior in subjects aged 65 years and older," the memo says.

At a Dec. 12 Alliance for Human Research Protection press conference, Joseph Glenmullen (Harvard Medical School) disagreed with Laughren's conclusion: "There is no way you could possibly explain that those side effects only occur in under-25 year olds."

Laughren notes that the agency's conclusions - which were supported by separate reviews by the safety group and the statistics reviewers - were similar to that reached in analyses published in the British Medical Journal, "i.e., that there does not appear to be an increased risk of completed suicide associated with assignment to either active drug or placebo in adults with [major depressive disorder] or various anxiety disorders."

FDA's meta-analysis relies on 372 antidepressant trials and almost 100,000 patients.

The two 2005 BMJ articles relied on some of the same data used by FDA. One of those studies found a two-fold increase in risk of suicide attempts in users of selective serotonin reuptake inhibitors compared to placebo. Laughren promised to comment on differences in FDA's results from the BMJ articles at the committee meeting.

PDAC will not vote on specific questions, but is being asked to review the meta-analysis results and discuss potential labeling modifications.

In Sept. 2004, PDAC and the Pediatric Advisory Committee voted to add a "black box" warning to antidepressant labeling after identifying a signal for an increased risk of suicidality for pediatric patients (¹ Also see "Antidepressant MedGuide Distribution Imminent; Unit-Of-Use Packs To Follow" - Pink Sheet, 4 March, 2005.).

- Daniel Poppy (d.poppy@elsevier.com)

Antidepressant Adult Suicidality Labeling To Be Presented For Advisory Committee Review

More from Archive

More from Pink Sheet