USA. The US FDA has issued a Public Health Advisory to highlight that adults receiving antidepressants should be closely monitored for signs of worsening depression or increased suicidality, in response to several recent scientific publications that have suggested a possible increased risk of suicidality in such patients. The FDA has advised that a complete review of all available data has started, in order to establish whether the risk of suicidality is increased in adults receiving antidepressants, but that the review will most likely take at least a year to complete. Although the FDA's current recommendations (close monitoring and evaluation by a health-care professional if increased suicidality occurs) are consistent with existing label warnings, the information will also be added to the Patient Information and Health-care Professional Sheets for the antidepressant indications.

References:

1. FDA Public Health Advisory. United States Food and Drug Administration, 30 June 2005 (http://www.fda.gov).

2. FDA Talk Paper. United States Food and Drug Administration, 1 July 2005 (http://www.fda.gov).