The proposed labeling changes also state that studies 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, the US regulator said.
The update follows the 2005 black box warning that was added to several antidepressants, describing a risk of suicidal behavior in children and teens. The negative publicity surrounding the decision prompted a drop in antidepressant sales in the US and across Europe.
The FDA emphasized that people currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.