FDA Begins Review of Suicide Risk Associated with Antidepressants
July 6, 2005
FDA Begins Review of Suicide Risk Associated with Antidepressants
The US Food and Drug Administration (FDA) is reviewing available data to determine whether or not antidepressant treatment raises the risk of suicidality (suicidal thinking or suicidal behavior). A timely move, as several scientific publications have recently suggested a link between suicidality and treatment with antidepressants, although the FDA began their review before these reports came out.
The FDA's comprehensive review will take one year or more. In the meantime, the FDA has issued the following cautionary recommendations:
- "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 FDA reports that the above recommendations are consistent with current warnings on package labeling, regarding antidepressant treatment of adults.
What the FDA Review Involves
The FDA's comprehensive review will involve hundreds of clinical trials and thousands of adult patients, and thousands of adverse events reported in these trials must be evaluated for possible evidence of suicidality.
During the review, the FDA is working with antidepressant manufacturers to identify all placebo-controlled trials conducted with adult subjects who received antidepressant treatment regardless of the indication that was studied. Additionally, the FDA has requested that manufacturers collect and present data in a similar fashion for placebo-controlled trials of antidepressants in pediatric patients.
The FDA will make its results available to the public in a report when it has completed the analyses.
Source: FDA Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications
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