FDA sees changes to antidepressant labels

The U.S. Food and Drug Administration plans to update antidepressant labels to reflect studies that suggest a link between the drugs and suicide in youth, according to documents released on Friday.

A new study by Columbia University showed “a statistically significant association of suicidal events with antidepressant drug treatment in short-term pediatric clinical trials for all indications,” said Dr. Andrew Mosholder in his review of the data posted on the agency’s Web site.

The FDA, in a separate statement, said while the data may suggest some suicide risk, inconsistencies in the results remained. Specific new language for the new labels was being developed, the agency said.

Provided by ArmMed Media
Revision date: June 20, 2011
Last revised: by Dave R. Roger, M.D.