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Antidepressant Paxil Has Been Linked To Birth Defects

An increased risk of severe birth defects, including septal heart defects and other congenital abnormalities, is associated with use of the anti-depressant drug Paxil (paroxetine) by pregnant women, particularly during the first trimester of pregnancy. If you or someone you love took Paxil during pregnancy, we may be able to help.

In December 2005 the U.S. Food and Drug Administration (FDA) issued a public health advisory warning of the increased risk of birth defects, particularly heart malformations, with Paxil use in pregnancy.

Paxil poses a particular risk for pregnant women. It is the only SSRI on the market that is classified by the FDA as a Category D drug. Category D means that studies in pregnant women have demonstrated a risk to the fetus. Paxil birth defects may include:

• Congenital heart defects such as atrial and ventricular septal defects, hypoplastic left heart syndrome, tricuspid atresia, and pulmonary stenosis
• Other birth defects such as neural-tube defects, craniosynostosis, infant omphalocele, congenital foot deformity (ie. club foot), anal atresia, and certain lung defects (ie. PPHN)

The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. One study showed the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first trimester was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

Most of the heart defects reported in these studies were atrial and ventricular septal heart defects (holes in the walls of the chambers of the heart), ranging in severity from minor defects to those requiring surgery to repair. The FDA advised doctors not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.

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