Lyrica Pregnancy Side Effects May Include “Major Birth Defects”: Study

The epilepsy and fibromyalgia drug Lyrica may increase the risk of major birth defects when taken during pregnancy, according to the findings of new research. 

In a study published last week in the online edition of the medical journal Neurology, Swiss researchers warn that women who take Lyrica during the first trimester may be three times more likely to give birth to a child with congenital malformations or birth defects. Lyrica pregnancy side effects were also linked to a decrease in live births due to abortions, some of which were deemed medically necessary.

Lyrica (pregabalin) is a blockbuster drug sold by Pfizer, which generated $3.6 billion last year. It is used to prevent epileptic seizures, but also use to treat fibromyalgia, anxiety and neuropathic pain. The label notes that some malformations were seen in rat studies, but that no human pregnancy studies were conducted. Lyrica is a Category C pregnancy drug, meaning that the risk of birth defects cannot be ruled out.

Researchers looked at data on 164 women in seven countries who used Lyrica during their first trimester of pregnancy, and compared the rate of birth defects and live births to 656 women who did not use the drug. Of the women who took the drug, 15 used it for neuropathic pain, 39 for psychiatric problems, five for epilepsy, and one for restless leg syndrome.

The study suggests that women who took the drug had triple the risk of having a child with major birth defects, including heart defects, and central nervous system defects. When looking at the rate of central nervous system defects alone, the women were six times more likely to have a child with such defects. The women who took Lyrica were also about three times as likely to terminate their pregnancy for medically necessary reasons.

Despite the findings, the researchers cautioned that the sample size was small and they were not able to find a causal link between Lyrica and birth defect risks.

“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,” study author Dr. Ursula Winterfeld, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland, said in a 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.”