Is Lyrica safe for pregnant or expecting moms? A recent study by the American Academy of Neurology (AAN) suggests that Lyrica (pregabalin) may not be safe as the study found that the drug may be associated with a higher risk of major birth defects.

More from an AAN media release:

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.

The major birth defects 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.

It is worth noting that, as the study authors themselves point out, this study is not a definitive conclusion because it is possible that the women who had birth defects may have been taking other drugs aside from Lyrica (pregabalin).

Says study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland:

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.

What do other medical experts say about the study? Well, they agree that the study does raise important questions on the effect of Lyrica on pregnant moms and their babies, that the conclusion is not definitive, and that there should be more studies in the future to further examine the link between Lyrica and birth defects.

So what should expecting moms do now? Here’s what study author Winterfield says: “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.”