Paxil and Increased Risk of Suicidality

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Paxil-maker GlaxoSmithKline has since added a black box warning to Paxil prescribing information in response to the FDA advisory. Click here for more information on this advisory.

In June 2005, the FDA issued a public health advisory announcing that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, including Paxil. The FDA advised that adults taking antidepressants (particularly those being treated for depression) should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins, and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications. Click here for more information on this advisory.

Most recently, in May 2006 GlaxoSmithKline and the FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the "WARNINGS" section of prescribing information for Paxil and Paxil CR. These labeling changes relate to adult patients, particular those who are younger adults. The results of a recent analysis of Paxil in adult patients showed a higher frequency of suicidal behavior in young adults. However, the FDA states that the results should be interpreted with caution, since the absolute number and incidence of events are small. All reported events of suicidal behavior in adult patients with Major Depressive Disorder (MDD) were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. Click