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U.S. Department of Health and Human Services

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Paxil (paroxetine HCL), Paxil CR Controlled-Release Tablets

Audience: Neuropsychiatric and other healthcare professionals

[Posted 09/27/2005] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets to describe the results of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants [OR 2.2; 95% confidence interval, 1.34-3.63]. Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.

[September 2005 - Dear Healthcare Professional letter - GlaxoSmithKline]