ACOG Advises Against Paroxetine Use During Pregnancy

The American College of Obstetricians and Gynecologists is advising physicians to avoid prescribing the antidepressant paroxetine (Paxil) to pregnant women and women planning to become pregnant, because of a possible increased risk of congenital heart malformations.

According to the ACOG Committee on Obstetric Practice, a number of studies have not shown increased risk of birth defects, but two recent unpublished studies did indicate an increased risk of atrial and ventricular septal defects with first-trimester exposure to paroxetine.

Last year the FDA issued an advisory regarding paroxetine use during pregnancy, cautioning that use during the first trimester could increase the risk for congenital malformations. They also requested that its manufacturer change its pregnancy category from C to D, meaning that the drug has been found to have a harmful effect on the developing fetus.

ACOG is recommending fetal echocardiography for women who were exposed to paroxetine early in pregnancy.

The committee opinion was published in the December issue of Obstetrics and Gynecology.