Antidepressant labeling updated yet again

May 7, 2007

The FDA is requesting an update to the existing black box to include information regarding the risk of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first two months of treatment.

The FDA has proposed new labeling changes to manufacturers of antidepressants. This time, the agency is requesting an update to the existing black box to include information regarding the risk of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first two months of treatment. In addition, manufacturers are asked to include a statement explaining that scientific data did not show this increased risk in adults older than 24 years and that patients over 65 years old actually have a decreased risk of suicidal thinking when taking antidepressants. Companies have 30 days to submit their updated product labeling and Medication Guides to the FDA for review. Labeling changes made in 2005 required the addition of a black box warning and Medication Guides to describe an increased risk of suicidal thinking and behavior in children and adolescents. The new agency request applies to the entire category of antidepressants.

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