Paxil and Other Antidepressants Associated with Birth Defects

The American College of Obstetricians and Gynecologists (ACOG) has recently published an opinion regarding the use of selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors for treatment of depression during pregnancy. ACOG warns that a particular SSRI known as Paxil (generic: paroxetine) should be avoided when possible by pregnant women or women who plan to become pregnant, due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects.

ACOG’s press release goes on to say that “…exposure to SSRIs late in pregnancy has been associated with short-term complications in newborns including jitteriness, mild respiratory distress, excessively rapid respiration, weak cry, poor muscle tone, and admission to the neonatal intensive care unit. Unpublished data regarding the use of Paxil during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations.”

In September, 2005, FDA’s Medwatch issued a Paxil Safety Information Alert, and GlaxoSmithKline, the maker of Paxil, wrote a letter to health care professionals stating, “Preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants….The most common cardiovascular malformations observed in the study were
ventricular septal defects.”

For women exposed to Paxil during early pregnancy, ACOG recommends that a fetal echocardiography be considered.