GlaxoSmithKline and the FDA advised doctors that there has been a change to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets. The possibility of Paxil birth defects may be more significant than previously believed.

The letter described the results of a GlaxoSmithKline retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study of 3,481 pregnant women suggested an increase in the risk of overall major congenital malformations for paroxetine (generic for Paxil) as compared to other antidepressants. 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.