Lausanne, Switzerland—Pregabalin, approved for treating epilepsy, fibromyalgia, and neuropathic pain—and often prescribed off-label for a variety of conditions—appears to be linked to an increase risk of major birth defects, according to a Swiss study.
The report, published online recently by the journal Neurology, advises caution in prescribing the drug, marketed as Lyrica, to women of childbearing age.
Study authors, led by researchers from Lausanne University Hospital, note that the drug often is prescribed off-label for generalized anxiety disorder and other mental health issues.
For the study, researchers collected information in seven countries from 164 women who took pregabalin during a pregnancy and 656 pregnant women who were not taking any antiseizure drugs. After the expected date of delivery, information was gathered from the mothers or their healthcare providers to determine outcomes.
Results indicate that infants born to the women who took pregabalin during the first trimester of pregnancy were three times more likely to have major birth defects than those of mothers who did not take antiseizure drugs. Birth defects due to chromosomal abnormalities were excluded.
Of the 116 pregnancies in women taking antiseizure drugs, 6% resulted in major birth defects, compared to 2% in women who did not take the drug, according to study authors. The major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs.
In fact, the expectant mothers taking pregabalin were six times more likely to have a child with a major CNS defect than those who were not taking the drug—with four CNS defects out of 125 pregnancies, 3.2%, compared to three CNS defects out of 570 pregnancies, or 0.5%.
Among the study participants, pregabalin had been prescribed for neuropathic pain in 115 patients, psychiatric disorders in 39, epilepsy in five and restless leg syndrome in one.
With 77% of the women beginning pregabalin before they became pregnant, they stopped taking the drug at an average of 6 weeks into their pregnancies. Of those, 13% were also taking another antiseizure drug.
“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,” explained study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland.
Winterfeld added in an American Academy of Neurology press release, “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.”
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