FDA Reviews Antidepressant Data

Published Online: Monday, August 1, 2005

The FDA is taking steps to ensure that patients and health care providers are aware of the possible increased risk of suicidal behavior in adults treated with antidepressants. The FDA's Public Health Advisory suggests the following:

  • Adults being treated with antidepressant medicines should be watched closely for signs of worsening depression and for increased suicidal thinking or behavior
  • Close observation of adults may be vital when antidepressant medications are started for the first time or when doses have changed
  • Adults whose symptoms worsen while being treated with antidepressants should be evaluated by their health care provider

Although the FDA issued the advisory in response to recent studies indicating the risk, they had already initiated the process of reviewing data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The FDA has asked manufacturers to provide data from their trials, using an approach similar to that used in the evaluation of the risk of suicidal behavior in children taking antidepressants. This process involves hundreds of clinical trials and may take more than a year to complete. The FDA will continue to provide updates as they become available. To view the Public Health Advisory, visit www.fda.gov/cder/drug/advisory/SSRI200507.htm.

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