FDA Issues New Warnings About Antidepressants and Suicide Risk

The FDA has issued a new advisory warning about the risks of suicide in patients taking antidepressant medications.

The FDA advisory follows its decision last year to require drug manufacturers to add or strengthen suicide-related warnings on their labels.

The new warning begins:

Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, the FDA began a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that:

• Adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased.
• Adults whose symptoms worsen while being treated with antidepressant drugs, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.

The agency is now conducting a review of many hundreds of clinical trials of antidepressant medications, checking thousands of adverse events for possible evidence of suicidality.