Popular Pain Drug Linked to Birth Defects

Pregabalin, which is sold under the name Lyrica, is approved in the U.S. to treat nerve pain, including fibromyalgia and pain caused by shingles and diabetes, as well as for seizures. Some physicians are also prescribing the drug off-label for generalized anxiety disorder. But the latest study shows it may contribute to birth defects as well.

In a report published in the journal Neurology, researchers at the Swiss Teratogen Information Service, a facility that collects reports of potential harmful effects of drugs, found that women who took pregabalin, or Lyrica, during pregnancy had a higher risk of having babies with birth defects. The risk of birth defects was three times as high if the expectant moms took the drug during the first trimester.

Combined with animal studies that also showed a higher rate of skeletal and neural tube defects among those exposed to pregabalin, the findings raise concern about the risk for pregnant women.

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The label for pregabalin notes that it is not recommended for women who are expecting, or hoping to become pregnant. But as the study’s senior author Dr. Thierry Buclin notes, many pregnancies are unplanned, which means women taking the drug could be unknowingly exposing their fetuses in utero to the drug. In fact, in the study, 77% of the women were on the drug before they learned they were expecting.

“We checked and rechecked all of the outcomes,” says Buclin. “We were a bit surprised by the positive finding of higher birth defects. It’s definitely concerning.”

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Buclin says that it’s the first study to find the link, so more research is needed to confirm the results, since the women who took pregabalin were more likely to be taking other medications, and also more likely to smoke. But the connection between the drug and birth defects remained strong even after the scientists adjusted for these potential effects.

Even with the tripling of risk, however, the chances of birth defects to begin with is very small, so the drug may contribute to negligible absolute increase for any individual woman.

Still, Buclin says, “We should increase caution in prescriptions for women of childbearing age.” Few studies include pregnant women out of fear of harming the developing fetus, but the truth is that many pregnant women rely on and need medications. Having a better understanding of which drugs might be safe for them and their babies, and which drugs are not, is more helpful than simply advising they avoid medications altogether.