FDA REVIEWS DATA FOR ANTIDEPRESSANT USE IN ADULTS

FDA REVIEWS DATA FOR ANTIDEPRESSANT USE IN ADULTS

U.S. Food and Drug Administration
MEDWATCH
FDA Talk Paper
July 1, 2005

In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory (PHA) to update patients and healthcare providers with the latest information on this subject.

Even before the publication of these recent reports, FDA had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.

In the meantime, the PHA advises health care providers and patients to be aware of the following:

  • Adults being treated with antidepressant medicines, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.

  • Close observation of adults may be especially important when antidepressant medications are started for the first time or when doses for the specific drugs prescribed have been changed.

  • Adults whose symptoms worsen while being treated with antidepressants, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.

These recommendations are consistent with warnings already present in approved labeling for antidepressants used by adults.

FDA will provide updated information as it becomes available. The Public Health Advisory is available on line at http:// www.fda.gov/cder/drug/advisory/SSRI200507.htm .

Media Inquiries:
Susan Cruzan, 301-827-6242

Consumer Inquiries:
888-INFO-FDA

 

Return to Paxil Advisories and Alerts Menu