Audience: Neuropsychiatric healthcare professionals and consumers
[UPDATE 07/08/2005] FDA notified healthcare professionals about the availability of updated Healthcare Professional and Patient Information Sheets for antidepressant medications that were the subject of a June 30, 2005 Public Health Advisory issued about the risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications.
[Posted 07/01/2005] In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the FDA has issued a Public Health Advisory 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.
[July 08, 2005 - Healthcare Professional and Patient Information Sheets - FDA]
[June 30, 2005 - Public Health Advisory - FDA]
[June 30, 2005 - Drug Information Page - FDA]