December 6, 2006

Women who are pregnant or trying to become pregnant should steer clear of the antidepressant drug Paxil because of the possible increased risk of birth defects, says the American College of Obstetricians and Gynecologists (ACOG).

The statement from ACOG's Committee on Obstetric Practice was published in the December issue of Obstetrics & Gynecology — a year after the U.S. Food and Drug Administration (FDA) advised the makers of Paxil to change the drug's labeling to "Category D" to convey that it be harmful to human fetuses.

The new labeling and warnings on the package came after GlaxoSmithKline, makers of Paxil, reported that in some studies pregnant women taking the drug during their first trimester were at greater risk of having a baby with heart defects, mainly atrial septal defects or ventricular septal defects, which involve underdevelopment of the wall between the right and left sides of the heart.

Paroxetine (the generic name for Paxil) is also sold as Paxil CR, Pexeva, and paroxetine hydrochloride. The drug is a selective serotonin reuptake inhibitor (SSRI) — the most common kind of medication (antidepressant) used to treat depression in the United States.

A recent study has linked other health risks to newborns in mothers who took SSRIs, such as newborn persistent pulmonary hypertension, a serious lung condition.

So it's important for health care providers to consider each woman's situation individually when prescribing SSRIs other than Paxil during pregnancy, ACOG said.

What This Means to You

As many as 1 in 10 women will have depression at some point during pregnancy or after the birth of their baby, according to ACOG. Although it's best for expectant mothers to avoid some medications whenever possible, having untreated depression during pregnancy comes with its own risks.

A recent study showed that pregnant women who stopped taking their depression medication were five times more likely to have a relapse (to become depressed again) than those who kept taking their medicine throughout pregnancy. And some studies have shown that pregnant women who don't get treatment for depression may be at risk for other health problems.

Some medications may especially affect a fetus during early pregnancy, so if you have depression and are pregnant or trying to conceive, talk with your doctor about everything you're taking. He or she can help you weigh the risks and benefits of various medications to figure out the best treatment options for you.

Reviewed by: Steven Dowshen, MD
Date reviewed: December 2006