May 08, 2007
FDA bolsters black box on antidepressants to warn of suicidality in young adults
The FDA asked antidepressant makers to update the black box warnings on their products to caution against increased risks of suicidality in young adults starting on the meds. The proposed labeling warns of increased risk of suicidality for users age 18-24 in the first two months of treatment, but says that scientific data do not show increased risk in adults over than 24 and that those 65 and older have a decreased risk of suicidality. The language also emphasizes that depression and other serious psychiatric disorders treated by the drugs are themselves the biggest danger to patients. Manufacturers have 30 days to submit revised product labels and medication guides to FDA for review. In 2005, FDA asked manufacturers to add a black box warning of a suicidality risk in children and adolescents on the drugs and initiated a review of 295 individual antidepressant trials involving 77,000 adult patients with major depressive disorder or other psychiatric disorders. The FDA’s move stems from the findings of that review.