Pregabalin, a drug often used for anxiety, pain, and other neurologic disorders, may be linked to a higher risk of major birth defects, researchers reported in a Neurology study. 

Pregabalin is an alpha2-delta ligand approved for the treatment of fibromyalgia, neuropathic pain associated with diabetic peripheral neuropathy (DPN) or spinal cord injury, postherpetic neuralgia (PHN), adjunct in partial onset seizures, and for off-label uses in generalized anxiety disorder and other psychiatric conditions. Researchers obtained data from 164 women who took pregabalin during pregnancy and from 656 pregnant women who did not take any anti-seizure medications. The study participants or their practitioners were contacted after the expected date of delivery. 

The women who took pregabalin during the first trimester of pregnancy were 3 times more likely to have a major birth defect compared to the women who did not take any anti-seizure drugs. Of the 116 pregnancies in women taking anti-seizure drugs, 7 (6%) resulted in major birth defects vs. 12 of the 580 pregnancies (2%) in women who did not take the drug. 

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Major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. Women who took pregabalin were 6 times more likely to have a pregnancy with a major CNS birth defect vs. women who were not taking the drug (3.2% vs. 0.5%, respectively). 

Among the women who took pregabalin, 115 were using it to treat neuropathic pain, 39 for psychiatric disorder (eg, depression, anxiety, bipolar disorder, psychosis), 5 for epilepsy, and 1 for restless legs syndrome. Study participants discontinued pregabalin around 6 weeks into their pregnancy. Researchers noted that about 13% of women taking pregabalin were also taking another anti-seizure medication. 

Ursula Winterfeld, PhD, Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland, stated, “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.” 

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