Paxil may increase risk of first-trimester malformations

December 19, 2005

Exposure to Paxil/Paxil CR (paroxetine HCl, GlaxoSmithKline) during the first trimester of pregnancy increases the risk for congenital malformations, especially cardiac malformations, according to the FDA. As a result, the manufacturer has changed Paxil's pregnancy category from C to D and added new recommendations to the prescribing information's Warnings section.

Exposure to Paxil/Paxil CR (paroxetine HCl, GlaxoSmithKline) during the first trimester of pregnancy increases the risk for congenital malformations, especially cardiac malformations, according to the FDA. As a result, the manufacturer has changed Paxil's pregnancy category from C to D and added new recommendations to the prescribing information's Warnings section.