FDA Wants Stronger Warnings on Antidepressant Labels

U.S. Food and Drug Administration proposal backs inclusion of suicidality in black box warnings

THURSDAY, May 3 (HealthDay News) -- The U.S. Food and Drug Administration has proposed that antidepressant medications carry stronger black box warnings about the risk of suicidal thoughts and behavior when used to treat depression in young adults. The new warnings, which are aimed at 18- to 24-year-olds, would add to warnings already in place since 2005 that apply to children and adolescents.

The call for stronger warnings arose from placebo-controlled studies showing antidepressants carry a slightly raised risk of suicidality in such patients in the early stages of treatment, usually the first few months. The labeling would state that this risk has not been seen in older patients and that in patients over 65, the suicidality risk may be lower.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products. Depression and other psychiatric disorders can have significant consequences if not appropriately treated," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, in a statement. "Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

Manufacturers of antidepressants must also produce FDA-approved patient guides in easily accessible language for patients, families and caregivers. In light of the new proposal, the manufacturers have 30 days to submit revised product labels and medication guides to the FDA.

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