MEDICATIONS: OPINION ISSUED ON SSRI ANTIDEPRESSANT USE DURING PREGNANCY

December 1, 2006 — The use of selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors for the treatment of depression during pregnancy should be individualized based on their respective risks and benefits, according to a new Committee Opinion issued by The American College of Obstetricians and Gynecologists' (ACOG) Committee on Obstetric Practice. The Committee also advised that a particular SSRI medication known as paroxetine (Paxil®) be avoided, when possible, by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects.

Reproductive-age women have the highest prevalence of major depressive disorders; approximately one in 10 women will have major or minor depression sometime during pregnancy and the postpartum period. SSRIs are commonly used to treat depression, but there are no hard data on the prevalence of their use during pregnancy.

Numerous studies have not found an increased risk of major birth defects associated with the use of SSRIs during pregnancy. However, 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 Unpublished data regarding the use of Paxil® during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations. Thus, the U.S. Food and Drug Administration issued a public health advisory regarding the use of Paxil® during pregnancy and the manufacturer changed its pregnancy category from C to D. A Category C classification is for drugs that have been shown to harm fetuses in animal studies but have not been adequately studied in humans. A Category D classification means a drug has been found to be harmful to human fetuses.

The potential risk of SSRIs during pregnancy must be weighed against the risk of depression relapse if the medication is discontinued. Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications. Fetal echocardiography should be considered for women who were exposed to Paxil® in early pregnancy.

ACOG's Committee on Obstetric Practice emphasizes that decisions about depression treatment should involve the obstetrician and the mental health clinician, along with the patient, ideally prior to pregnancy. However, because approximately 50 percent of pregnancies are unplanned, preconception planning for women with depression will not always be feasible, and treatment decisions about SSRIs will undoubtedly occur during pregnancy.