Antidepressant black boxes updated
Executive Summary
Class labeling for antidepressants is updated Aug. 2 to include warnings about increased risks of suicidality in young adults ages 18 to 24. The new language, which FDA proposed in May, states that risk was not seen in adults older than 24 and that the risk decreased for adults ages 65 and older (1"The Pink Sheet" May 7, 2007, p. 32). Also added is a statement that "Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide." The Psychopharmacologic Drugs Advisory Committee voted to recommend the changes at a 2006 meeting on the risk of drug-related suicidality in adults (2"The Pink Sheet" Dec. 18, 2006, p. 3). The black box warning on suicidality in pediatric patients was first added in 2005...
You may also be interested in...
Antidepressants’ Revised Med Guides Is A Step Backward – Rep. Ferguson
A United States Congressman wants FDA to revert back to language that was contained in previous medication guides regarding antidepressant agents and the risk of suicide in children
FDA May Revisit Antidepressant “Black Box” Suicidality Warning
FDA will monitor emerging data on suicides and antidepressants as it becomes available to determine if an uptick in suicides among adolescents is associated with the decline in prescriptions for antidepressants that followed the addition of a "black box" warning to labeling for the products
Changes To Antidepressant Black Box On Suicide Recommended By FDA Panel
FDA's findings that the suicidality risk with antidepressants does not extend beyond young adults should be added to the current "black box" warning on pediatric suicidality, the Psychopharmacologic Drugs Advisory Committee says