GlaxoSmithKline and the FDA are warning that a study has identified a risk of major congenital malformations in infants born to women taking Paxil and Paxil CR during the first trimester of pregnancy.
A long-term epidemiological study suggested an increase in the risk of overall major congenital malformations for Paxil (paroxetine) and Paxil CR compared to other antidepressants.
"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," the FDA said.
Labels for Paxil and other antidepressant drugs already include the possibility that the drugs can cause birth defects.
Last month, Norwegian researchers said Paxil is associated with a higher risk of suicide in adults. The drug, which is currently not approved for use by children, has been the subject of 16 scientific reviews, which were analyzed for the Norwegian study.
