Update black box warnings on antidepressants, says FDA

May 18, 2007

The Food and Drug Administration proposed that all manufacturers of antidepressant meds update their existing black box warnings. The product labels should include warnings about increased risks of suicidal thinking and behavior, in 18- to 24-year olds, usually in the first two months of treatment [more].

The Food and Drug Administration proposed that all manufacturers of antidepressant meds update their existing black box warnings. The product labels should include warnings about increased risks of suicidal thinking and behavior, in 18- to 24-year olds, usually in the first two months of treatment [more].

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicide.

The proposed change applies to the entire category of antidepressants, and follows similar labeling changes made in 2005 that warned of a suicide risk in children and adolescents who take antidepressants.