A new study published online in the journal Neurology on May 18, 2016, reports that pregnant women who took Lyrica (pregabalin) during their first trimester were found to be three times more likely to give birth to a baby with major birth defects than women who did not take the widely prescribed drug.

Lyrica is approved for the treatment of neuropathic pain, seizures and fibromyalgia but is also often prescribed “off-label” for depression, anxiety and other mental disorders. The study involved 820 pregnant women -- 164 took the drug during their first trimester and 656 did not take the drug at all.

Among the women who took Lyrica, a majority (115) were using the drug to treat neuropathic pain. Six percent of the women on the drug gave birth to babies with major birth defects compared with only two percent of the women not on the drug. These birth defects included heart defects and problems with the central nervous system and other organs. Women who took Lyrica were six times more likely to give birth to an infant with major defects in the central nervous system.

The research was performed by Ursula Winterfeld, PhD, and other colleagues from the Swiss Teratogen Information Service and Lausanne University Hospital in Switzerland. In an accompanying editorial, Dr. Page Pennell of Harvard Medical School noted that the study did have several limitations. Still, she noted that “The risk of birth defects is probably higher with Lyrica. It’s just that we can’t prove it with this study.”

The FDA currently categorizes Lyrica as a pregnancy category C, meaning that adverse affects have been found in animal studies but there have been no adequate or well controlled studies in pregnant women.

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