FDA ADDS YOUNG ADULTS TO ANTIDEPRESSANT BLACK BOX SUICIDE WARNING
The FDA is planning to expand its black box warning for all antidepressants to warn that young adults using these drugs face a greater risk of suicidality, the agency announced late Wednesday.
The agency presented the findings of 372 placebo-controlled antidepressant trials to its Psychopharmacologic Drugs Advisory Committee Dec. 13. These studies of nearly 100,000 patients found that "there is an elevated risk for suicidality and suicidal behavior among adults younger than 25 years of age that approaches that seen in the pediatric population." The study reviewed antidepressant drugs such as Prozac, Paxil, Zoloft, Wellbutrin, Cymbalta and Luvox.
The study follows two advisory meetings in 2004 where higher suicide risks were found among pediatric patients. The agency consequently required manufacturers to change their labels to add warnings to alert healthcare providers and subjects about increased risks in children and adolescents.
In the latest decision, the committee agreed unanimously that some change in these drugs' labels was necessary and voted 6-2 in favor of expanding the black box warning, FDA officials said during a conference call. While the committee did not vote on a particular age cutoff, the agency will now require a warning that increased suicide risk occurs in patients under 25 years of age.
But the agency has not decided on the exact language of the warning and will likely meet with outside groups before making any changes. The committee expressed "a fair amount of anxiety" about the wording of the label, Thomas Laughren, the director of the agency's Division of Psychiatry Products, said.
The agency is also likely to include an explanation of the benefits of these drugs, FDA officials said.
The briefing document is available at www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4272b1-01-FDA.pdf (http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4272b1-01-FDA.pdf).