According to a new study published in Neurology, the medical journal of the American Academy of Neurology, pregabalin, commonly known by its brand name, Lyrica, may cause major birth defects. Pregabalin is approved by the U.S. Food and Drug Administration (FDA) for epilepsy, fibromyalgia, and neuropathic pain, but is also prescribed “off label” for anxiety or depression, according to Medical Daily.
The study found that women taking pregabalin were six times more likely to have a pregnancy with a major birth defect than women not taking the drug. The birth defects included heart defects and structural problems with the central nervous system (CNS), as well as other organs, Pain News Network reports.
Lyrica is the top-selling drug for Pfizer, generating over $5 billion in annual sales, and is approved for use in more than 130 countries. Nearly 700 pregnant women in seven different countries were involved in the international study.
Four (4) had children with central nervous system defects
Of the 125 women who took pregabalin, four (4) had children with central nervous system defects, or 3.2 percent. Of the 570 women who did not take pregabalin, the birth rate defect was 0.5 percent, reports Pain News Network.
Dr. Ursula Winterfeld, study author and associate of the Swiss Teratogen Information Service and Lausanne University Hospital in Switzerland said, “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.
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,” Medical Daily reports.