Paroxetine: first trimester exposure and congenital malformations.(Safety and Efficacy Issues)

Canada -- The manufacturer of paroxetine (Paxil[R]) has informed health care professionals of important new safety information regarding use during the first trimester of pregnancy.

The preliminary report of a retrospective epidemiological study of 3581 pregnant women exposed to paroxetine or other antidepressants during the first trimester indicates an increased risk for paroxetine compared to other antidepressants.

Cardiovascular malformations with ventricular septal defects were the most frequent type of cardiovascular defect reported in the paroxetine-exposed group. Other independent studies of pregnancy outcome following first trimester exposure to …