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    New warnings about Paxil and Paxil CR (paroxetine) September 28, 2005 - SALT LAKE CITY, UTAH - GlaxoSmithKline (GSK) and the FDA notified health care professionals of changes to the Pregnancy/Precautions section of the Prescribing Information for Paxil (paroxetine) 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. As with all Pregnancy Category C drugs, health care providers are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy. It is recommended that health care providers discuss these latest findings, as well as treatment alternatives, with their patients. Paroxetine should be used during pregnancy only if the potential benefit justifies the potential risks to the fetus.
Patients taking Paxil or Paxil CR should NOT discontinue taking their medication before speaking with their physician.
As always, pharmacies and members can contact the RxAmerica customer service desk at 1-800-770-8014 if they have any questions about this product recall. |
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