A drug commonly used to treat epilepsy, pain, anxiety and other brain health disorders may be linked to an increased risk of major birth defects, according to a new study.
Pregabalin is marketed as Lyrica in the United States and under a number of brand names worldwide. It is approved by the FDA for treatment of epilepsy, fibromyalgia and neuropathic pain, such as pain from diabetic neuropathy or pain after shingles or spinal cord injury. It is also prescribed “off-label” for generalized anxiety disorder and other mental health issues.
In the study, data was collected in seven countries from 164 women who took pregabalin during a pregnancy and 656 pregnant women who were not taking any anti-seizure drugs. The women or their practitioners were then contacted again after their expected date of delivery.
Triple The Risk
Pregnancies of the women who took pregabalin during the first trimester of pregnancy were three times more likely to result in major birth defects than those of the women who did not take anti-seizure drugs.
Seven of the 116 pregnancies in women taking anti-seizure drugs, or 6 percent, had major birth defects, compared to 12 of 580 pregnancies, or 2 percent, in women who did not take the drug. Birth defects due to chromosomal abnormalities were not included in these results.
Major birth defects observed included heart defects and structural problems with the central nervous system (CNS) or other organs. The women taking pregabalin were six times more likely to have a pregnancy with a major defect in the central nervous system than women who were not taking the drug, with four CNS defects out of 125 pregnancies, or 3.2 percent, compared to three CNS defects out of 570 pregnancies, or 0.5 percent.
Of the women taking pregabalin, 115 were taking it to treat neuropathic pain, 39 were taking it for psychiatric disorders, including depression, anxiety, bipolar disorder and psychosis, five were taking it for epilepsy and one was taking it for restless leg syndrome.
Pregabalin received U.S. FDA approval for use in treating epilepsy, diabetic neuropathic pain, and postherpetic neuralgia in December 2004, and appeared on the U.S. market in fall 2005.
In June 2007, the FDA approved Lyrica as a treatment for fibromyalgia. It was the first drug to be approved for this indication and remained the only one until duloxetine gained FDA approval for the treatment of fibromyalgia in June 2008.
Generic versions of pregabalin became available in Russia in 2011, in Canada in 2013, Iceland 2014, and are expected to become available in the European Union and the U.S. in 2016 and 2018 respectively.
“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,”
said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland.
“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,” she added.
Ursula Winterfeld, Paul Merlob, David Baud, Valentin Rousson, Alice Panchaud, Laura E. Rothuizen, Nathalie Bernard, Thierry Vial, Laura M. Yates, Alessandra Pistelli, Maria Ellfolk, Georgios Eleftheriou, Loes C. de Vries, Annie-Pierre Jonville-Bera, Mine Kadioglu, Jerome Biollaz, and Thierry Buclin Pregnancy outcome following maternal exposure to pregabalin may call for concern Neurology, May 2016 DOI: 10.1212/WNL.0000000000002767