Pregabalin May Cause Major Birth Defects

Findings from a recent study suggest that pregabalin, a common drug used to treat pain, epilepsy, anxiety, and other brain disorders, could increase the risk of major birth defects.

Pregabalin was approved by the FDA for treating epilepsy, fibromyalgia, and neuropathic pain, but can also be prescribed for anxiety and other mental health issues.

The study, published in Neurology, included 164 women who took the drug during pregnancy and 655 pregnant women who were not taking anti-seizure drugs. Researchers contacted the women or their physicians after their delivery.

Approximately 77% of women started pregabalin prior to pregnancy and stopped taking the drug at an average time of 6 weeks into their pregnancy. About 13% of the women taking pregabalin were also taking another anti-seizure drug.

Researchers discovered that women who took pregabalin during the first trimester were 3 times more likely to have babies with major birth defects compared with women who were not taking anti-seizure drugs, according to the study.

Major birth defects were defined as heart defects and structural problems with the central nervous system (CNS) or other organs. Approximately 6% of women taking the drug had babies with major birth defects compared with 2% of babies from women not taking the drug.

Women taking the drug were 6 times more likely to have a pregnancy with a major defect in the CNS than women not taking pregabalin, and had 4 CNS defects out of 125 (3.2%) compared with 3 CNS defects out of 570 (.5%), according to the study.

"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 signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy," concluded study author Ursula Winterfeld, PhD. "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. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted."