Epilepsy Drug Pregabalin May Be Linked to Increased Risk of Birth Defects, Study Shows

Epilepsy Drug Pregabalin May Be Linked to Increased Risk of Birth Defects, Study Shows

A drug that is frequently used in the treatment of pain, anxiety, epilepsy, and a series of brain health disorders might be liked to a greater risk of major birth defects. The study establishing the connection was published in the American Academy of Neurology’s medical journal Neurology, in the May 18 online issue.

The drug in question is pregabalin, a U.S. FDA-approved treatment for epilepsy, fibromyalgia, and neuropathic pain — such as pain from diabetic neuropathy or pain from spinal cord injury. In addition, the drug is also commonly prescribed off-label for generalized anxiety disorder and other mental health issues.

The research project collected information in seven countries from 164 pregnant women who took pregabalin during their gestation and 656 women who were pregnant at the time and who were not taking any anti-seizure drugs. All women were contacted, either directly or through their practitioners, after their expected delivery date.

A total of 77 percent of the women in the study reported they started taking pregabalin before they became pregnant. All women in the study stopped taking the drug an average of six weeks into their pregnancies. Of those women who took pregabalin, 13 percent (or 22 women) were also on another anti-seizure drug.

The study found that 115 women took pregabalin for neuropathic pain; 39 for psychiatric disorders such as depression, anxiety, bipolar disorder and psychosis; five were taking it for epilepsy; and one for restless leg syndrome.

The study results showed that pregnancies of women who were taking pregabalin during their first pregnancy trimester were three times more likely to end up with major birth defects than those of women who weren’t taking any anti-seizure drugs. The pregnancies of the women who took pregabalin were six times more likely to have major birth defect in the CNS than those of women not taking the drug — four CNS defects per 125 pregnancies, or 3.2 percent, compared to three CNS defects per 570 pregnancies, or 0.5 percent.

Seven of the 116 pregnant women (6 percent) taking anti-seizure drugs ended up with major birth defects, compared to the 2 percent (12 out of 580) in women not taking the drug. Birth defects due to chromosomal abnormalities were not included in this study’s results. The major birth defects included heart malfunctions and structural problems associated with the central nervous system or other organs.

“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 Winterfield, Ph.D., in a press release.

Winterfield serves at the Swiss Teratogen Information Service and Lausanne University Hospital in 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,” she said. “In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted.”

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