FDA sees changes to antidepressant labels

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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.

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