New Information on Paxil & Congenital Malformations (Mar 06)

New warnings have been added to the labeling for Paxil and generic paroxetine based on preliminary analyses of two recent unpublished epidemiologic studies. Both studies showed a relatively small increased risk for cardiac defects in infants born to women who received the drug in early pregnancy, and one study also showed an increased risk of congenital malformations overall.

In both studies, the most common types of cardiac abnormalities in children of women who took Paxil were atrial and ventricular septal defects, with a wide range of severity. Neither of the studies addressed the question of whether the risk might extend to use of the drug later in pregnancy.

FDA is recommends that Paxil generally not be started in women who are planning to become pregnant, or are in the first trimester of pregnancy. If a woman is already on Paxil, the physician should alert her about the potential risk to the fetus. The physician should also consider discontinuing the drug in these women, although in individual cases the benefits of continuing Paxil may outweigh the potential risk to the fetus. If Paxil is discontinued, it should be tapered off and not stopped suddenly.

Additional Information:

FDA MedWatch Safety Alert - Paroxetine HCl - Paxil and generic paroxetine. December 8, 2005.
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil3

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• Paxil
• Congenital
• Malformations
• Infants
• FDA
• Cardiac
• Defects
• Patient
• Safety
• Drug
• Reaction