New warnings about Paxil and Paxil CR (paroxetine)

December 13, 2005 - The FDA has determined that exposure to Paxil/Paxil CR (paroxetine HCl) in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA's request, the manufacturer has changed paroxetine's pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine's prescribing information. The FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.

Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.

For further information, patients can contact GlaxoSmithKline at 1-888-825-5249. As always, pharmacies and members can contact the RxAmerica customer service desk at 1-800-770-8014 if they have any questions about this new product information.