Fibromyalgia, Neuropathy Pain Drug Tied to Birth Defects

Pain medications can often cause side effects such as dizziness and sleepiness; but little do pregnant women know that they could be at risk for birth defects when taking pregabalin.

In addition to pain, the US Food and Drug Administration (FDA) approved pregabalin, branded as Lyrica, for adults with fibromyalgia, post-shingles pain, and diabetic or non-diabetic-related neuropathic pain. It can also be prescribed to treat epilepsy, anxiety, and other brain disorders. The medication’s label points out potential side effects, like allergic reactions, suicidal thoughts, and swelling limbs, but a new study published in Neurology indicates another serious potential outcome.

First author Ursula Winterfeld, PhD, from the Swiss Teratogen Information Service and Lausanne University Hospital in Switzerland, and colleagues examined 164 pregnancies where the women took pregabalin and compared them to 656 controls.

Out of all of the women, 77% of them had started taking pregabalin before they got pregnant and the average time into pregnancy before they stopped taking the medication was six weeks. Twenty-two women (13%) who were taking pregabalin were also taking another anti-seizure drug.

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Those who took pregabalin during the first trimester of pregnancy were three times more likely to have a child with major birth defects, when compared to controls (7% vs. 2%). These birth defects included heart defects and central nervous system (CNS) structural problems, as well as other organ issues. Further analysis revealed that a major CNS defect was six times more likely to occur in women taking pregabalin than controls (7% vs. 0.5%).

“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,” Winterfeld said in a news release.

This data is even more concerning because the majority of people with fibromyalgia are women — with one study showing a 1:9 male-female ratio. Therefore, it’s fair to think that many pregabalin users are women.

“We can’t draw any definitive conclusions from this study,” Winterfeld advised, “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 defects after taking pregabalin during the first trimester of pregnancy.”

These findings indicate that women who have taken pregabalin during pregnancy may need extra fetal monitoring.

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