“The American College of Obstetricians and Gynecologists (ACOG) recommends that pregnant women and those wishing to become pregnant refrain from taking Paxil (paroxetine) because of the risk for birth defects.
The college’s Committee on Obstetric Practice made the recommendation in an opinion published in the December issue of Obstetrics & Gynecology. It noted unpublished data from two registries suggesting a 1.5- to 2-fold increased risk for atrial and ventricular septal defects associated with paroxetine exposure in the first trimester. Based on these data, the manufacturer has changed the drug’s pregnancy category from C to D.
The ACOG committee recommends that decisions about treating depression in pregnancy be individualized and that fetal echocardiography be considered for women exposed to paroxetine early in their pregnancies.
Journal Watch Psychiatry Associate Editor Dr. Deborah Cowley cautioned that the evidence reported so far is not strong enough to definitively conclude that Paxil raises the risk for cardiac malformations, but, she says, “For now, I would avoid using Paxil in pregnancy if possible.” ”
According to the statement by Glaxo-SmithKline, doctors should advise their patients of the potential harm to the fetus and recommend discontinuing paroxetine therapy or switching to another antidepressant.