Researchers are warning that a drug commonly prescribed to treat pain, anxiety, epilepsy and other brain health conditions may be associated with an increased risk of major birth defects. The drug, pregabalin, is approved by the Food and Drug Administration to treat a variety of disorders, but it also is used for generalized anxiety and other mental health issues.

In a study published Wednesday in an online issue of Neurology, researchers collected information from 164 women in seven countries who took pregabalin during pregnancy, and from 656 pregnant women who did not take any anti-seizure drugs. According to a news release, a follow-up was conducted with the women and their practitioner after their expected due date.

Researchers found that women who took pregabalin during the first trimester of pregnancy were three times more likely to give birth to a child with major birth defects than those who did not take anti-seizure drugs. The results found seven of the 116 pregnancies in women taking anti-seizure drugs had major birth defects, compared to 12 of the 580 pregnancies in women who did not.

According to the news release, the major birth defects included heart defects, structural problems with the nervous system or other organs. And while women taking pregabalin were six times more likely to have a pregnancy with a major defect in the central nervous system, researchers could not conclusively determine a cause-and-effect relationship.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because the study was small and the results need to be confirmed with larger studies, but these results do not signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland, said in a news release.

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In the group of women taking pregabalin, 115 were taking it for neuropathic pain, 39 were taking it to treat psychiatric disorders, five were taking it for epilepsy and one was taking it to treat restless leg syndrome.

“Pregabalin should be prescribed for women of child-bearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control,” Winterfeld said. “In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted.”