News & Publications

FDA MedWatch - Paxil/Paxil CR (paroxetine HCl) Public Health Advisory

December 15 , 2005
by: FDA MedWatch
Published in www.fda.gov

Exposure in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations

The FDA has determined that exposure to paroxetine 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. 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.

Read the complete MedWatch 2005 Safety Summary, including links to the FDA Public Health Advisory and the FDA Drug Information Page that includes links to the Healthcare Professional and Patient Information Sheets, at: http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil3


This Web page contains links to miscellaneous U.S. Food and Drug Administration (FDA) announcements that ASRM felt were relevant enough to archive on the ASRM Web Site. You can visit the FDA's web site at http://www.fda.gov/ 

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