US FDA to update black box warnings for young adults taking antidepressants

The US Food and Drug Administration has proposed that producers of all antidepressants update the existing black box warning on their products' labeling to include warnings about the increased risks of suicidal thinking and behavior, known as "suicidality," in young adults, ie, aged 18 to 24 years during initial treatment (generally the first one to two months).

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 suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, Director of the agency's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks," he added.