FDA Urged to Strengthen Warning on Labels of Antidepressants

An FDA advisory panel has recommended strengthening the warning now printed on labels of some antidepressants.

Selective serotonin reuptake inhibitors (SSRIs), a family of antidepressants that includes Prozac and Zoloft, may increase the risk of suicidal behavior in adults, according to recent research by the FDA. The finding, which comes three years after the agency warned that the meds can raise the risk of suicidal behavior in teens, is the first to show adults also at risk.

In light of the research, an FDA advisory panel urged the agency to strengthen the warning now printed on labels of these medications. The current label urges physicians to consider the risk of suicide when prescribing the meds, and to carefully monitor patients who use them. The panel also acknowledges that untreated depression can lead to suicide.

In a letter to the FDA, Mental Health America (formerly the National Mental Health Association), a leading non-profit coalition of psychiatric and mental health groups, urged the agency to “consider the potential impact of the agency’s public statements on the risks and benefits of antidepressants,” to avoid discouraging people from seeking help for depression. According to the coalition, “it is important to draw lessons from previous pediatric warnings and ensuing media coverage that created barriers to care and unnecessarily scared families away from treatment.”