GSK responds to FDA talk paper on pediatric data on Paxil.

Pharmaceutical company GlaxoSmithKline (GSK) PLC has responded to the U.S. Food and Drug Administration (FDA) talk paper recommending that Paxil, which is not approved for pediatric use, should not be used in children and adolescents under 18 years for the treatment of major depressive disorder (MDD). The agency said it has not yet completed a review of the safety data, and has not definitively determined if there is an increased risk of suicidal behavior in pediatric patients with MDD. "The FDA is communicating with patients and physicians while they continue to review the data on Paxil in children and adolescents," said Dr. David Wheadon, GSK's senior vice president of regulatory affairs.