May 22, 2006

GlaxoSmithKline (GSK) and the FDA have notified healthcare professionals of changes to the "Clinical Worsening and Suicide Risk" subsection of the "Warnings" section on labels for Paxil and Paxil CR, the FDA announced in a MedWatch alert posted May 12. The labeling changes relate to adult patients, particularly younger adults.

GSK sent a letter to healthcare professionals dated May 2006 to advise them of the new labeling indications for Paxil (paroxetine HCI) and Paxil controlled-release (CR) tablets. A recent meta-analysis of placebo-controlled clinical trials of Paxil showed an increased risk of suicidal behavior and ideation in adult patients who used the drug. The analysis "indicates that young adults, particularly those with MDD, may be at increased risk for suicidal behavior with paroxetine," says GSK. Adults of all ages with MDD also experienced a higher frequency of suicidal behavior when treated with Paxil compared to a placebo, the company said.

GSK's medical information to health professionals can be viewed at http://www.gsk.com/media/paroxetine/mi_letter.pdf (http://www.gsk.com/media/paroxetine/mi_letter.pdf).

The FDA's MedWatch alert on Paxil labeling is available http://www.fda.gov/medwatch/safety/2006/safety06.htm#paxil (http://www.fda.gov/medwatch/safety/2006/safety06.htm#paxil).