Antidepressants & Suicide, FDA Warns

The FDA has warned that children and adults taking antidepressants can become suicidal in the first weeks of therapy and that physicians should watch patients closely when first giving the drugs or changing dosages. The FDA is asking drug manufacturers to place explicit warnings about the drugs' side effects, including the risk of suicide, on their labels.

Comment: This action by the FDA in issuing a broad warning is most unusual. The FDA has traditionally based its decisions on convincing evidence. But there is still no convincing evidence linking antidepressants and suicide. (Congress has been pressuring the FDA to take a stand on this issue.) Whether scientifically warranted or not, the FDA's warning is a good reminder that antidepressants are not without risks.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors,

Depression & Suicide

Antidepressants to carry warning

FDA Issues Public Health Advisory on Cautions for Use of Antidepressants in Adults and Children

The Food and Drug Administration today issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.

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