FDA Urged to Require Warning Labels on Antidepressants

All antidepressant drugs should carry a "black box" warning that they may increase suicidal behavior in children, recommended a special panel of FDA advisers. Such a warning is one of the strongest that FDA can use to inform physicians and consumers of the need for caution in using a drug. After hearing two days of testimony about the effects of antidepressants, the panel decided that the warning should state clearly that aggregate data from studies of antidepressants show that they nearly double the risk of suicidal behavior and thoughts in minors suffering depression, and that the increase is caused by the medications themselves, not by the underlying condition. "We have very good evidence of harm and very little evidence of efficacy," said Thomas Newman, a professor of epidemiology and pediatrics at the University of California, San Francisco. In clinical trials, Prozac (fluoxetine) is the only drug that seemed to benefit pediatric patients, and its benefit was not large. The panel also decided that every prescription should include an easy-to-read pamphlet clearly warning parents that children using the drugs should be monitored for suicidal tendencies. FDA usually follows the advice of its advisory committees.