Paxil in Pregnancy

“The antidepressant Paxil (paroxetine) may cause fetal cardiac malformations, and the drug should be shunned if possible in pregnancy, recommended an advisory committee of the American College of Obstetricians and Gynecologists.

"At this time, paroxetine use among pregnant women and women planning pregnancy should be avoided, if possible," wrote members of the ACOG committee on obstetric practice in the December issue of Obstetrics & Gynecology.

-- SNIP --

“Although several previous studies have failed to find a link between SSRI use in pregnancy and major congenital malformations, GlaxoSmithKline, the maker of Paxil, has revealed that unpublished reports from a U.S. insurance-claims database and a Swedish national registry have suggested a possible link between Paxil used in the first trimester and increased risk of atrial and ventricular septal defects, pointed out the committee.

An estimated 2% to 3% of women use Paxil or another selective serotonin reuptake inhibitor (SSRI) during pregnancy, the authors noted.

In the Swedish report, women who received Paxil in early pregnancy had about a twofold increased risk for having an infant with a cardiac defect compared to the entire national registry population.

In the U.S. study, children born to women who took Paxil in the first trimester had a 1.5-fold increased risk for cardiac malformations, and a 1.8-fold increased risk for congenital malformations overall compared with children of women who took other antidepressants, according to an FDA advisory issued in December 2005.

In both instances, the findings were restricted to Paxil, and not to other SSRIs.”

Source.

A recent review reached similar conclusions regarding paroxetine’s safety during pregnancy. Outside of increasing risk for suicide, increasing the risk of congenital heart defects, and being associated with problematic discontinuation symptoms (here, here, here, and here for links on the difficulties of stopping a regimen of Paxil), paroxetine ain't so bad!