Pregnancy Warning Added to Paxil Label

Portrait by a Mother Suffering from Depression

A priority for women suffering from depression is how best to insulate their children from it, says painter and mother Amy Newell. Amy Newell/American Radioworks hide caption

itoggle caption Amy Newell/American Radioworks

Drugmaker GlaxoSmithKline has sent a warning letter to doctors, advising that the antidepressant Paxil may be linked to a slightly higher risk of birth defects in babies exposed to the drug during the first trimester of pregnancy. The company also has added the warning to its Paxil label. This comes on the heel of a new study requested by the Food and Drug Administration.

The Study

   

Methodology

   

— GlaxoSmithKline researchers compared the rate of birth defects among 3,581 pregnant women who took antidepressants during their first trimester with the rate of birth defects in the general population.

   

Findings

   

— Four percent of women taking Paxil delivered babies with congenital birth defects.

   

— Two percent of women taking other antidepressants had babies with congenital birth defects.

   

— The rate of similar birth defects in the general public is three percent.

   

Conflicting Data

   

— A separate Swedish study found no increased risk for major birth defects in infants exposed to Paxil in early pregnancy.

   

— Earlier studies have found that babies exposed to antidepressants toward the end of pregnancy may suffer withdrawal.  

   

Glaxo's Conclusion

   

— More studies on the effects of antidepressants on fetuses are needed. In the meantime, health care professionals are advised to discuss the potential risks with patients, and Paxil should only be used during pregnancy if "the potential benefit justifies the potential risks to the fetus."

Glaxo described the findings as a surprise. Other studies had shown no increase in birth defects. In the latest study, the company looked at data from more than 3,500 pregnant women taking antidepressants. It found four percent of the women taking Paxil had babies born with birth defects, compared to two percent taking other antidepressants. For comparison, the rate of birth defects in the general population is about three percent. In this study, the most common birth defects with Paxil were heart problems.

The FDA's Dr. Sandra Kweder says the agency had requested the study, but it also was surprised by the results. "It does conflict with other information that's been available," she said. "For that reason, we decided better to be safe and put that information out there."

The FDA has posted Glaxo's letter on its Web site, but Kweder adds the Paxil label has always warned doctors to weigh the potential risks and benefits of prescribing drugs in this class during pregnancy.

Dr. Lee Cohen, a perinatal psychiatrist at Massachusetts General Hospital, cautions that the new findings don't mean pregnant women who are currently taking Paxil should stop taking the drug. Exposing a baby to the mother's depression is also a health risk, he says. Women who are depressed don't take as good care of themselves, says Cohen, and are more likely to use drugs and alcohol, eat poorly and miss prenatal appointments. Research also suggests that women with depressive symptoms during pregnancy have children with lower birth weights.

Last year, another warning about antidepressants and pregnancy was issued: babies exposed to the drugs at the end of pregnancy could suffer from withdrawal. Dr. Sandy Zeskind, who directs neurodevelopmental research at the Carolinas Medical Center, says the latest study on Paxil shows there's a need for further research on antidepressants and pregnancy.

The FDA plans to review the new information about Paxil and pregnancy over the next few months to decide whether the additional warning on the label is sufficient.

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