Epilepsy Drug Lyrica Linked to Birth Defects Risk
Expectant mothers should probably avoid the drug, experts say, although study didn't prove cause and effect
By Steven Reinberg
WEDNESDAY, May 18, 2016 (HealthDay News) -- The widely prescribed drug pregabalin (Lyrica) may slightly increase the risk for birth defects, a new study suggests.
In a small study, researchers found that among women taking Lyrica during the first trimester of pregnancy, 6 percent had infants with major birth defects. In women who weren't taking the drug, 2 percent had a baby with a major birth defect, the study found.
"These results should be taken with caution," said study senior author Dr. Thierry Buclin, from the Swiss Teratogen Information Service and the division of clinical pharmacology at the Lausanne University Hospital, in Switzerland. "It's a warning, but it cannot be taken as a certainty."
Lyrica is prescribed for a range of health problems, including epilepsy, fibromyalgia and anxiety.
The new study findings should be investigated further, Buclin said. "We should not unduly alarm mothers-to-be about a definite risk. This is just a signal, a warning that there might be a problem with Lyrica," he said.
Experiments in animals have also linked Lyrica to birth defects, Buclin said. "But there are many examples of drugs showing an adverse effect, which turn out to be rather safe in humans," he explained.
Buclin doesn't currently recommend Lyrica for women who are thinking about becoming pregnant.
Steven Danehy, a spokesman for Pfizer Inc., the maker of Lyrica, said, "The study has significant limitations and cannot be used to draw definitive conclusions."
The study was small, did not account for other medical conditions or medications, "and the women taking Lyrica had higher rates of smoking and diabetes, all of which can negatively affect pregnancy outcomes," Danehy said.
The report was published online May 18 in the journal Neurology.
Lyrica is approved by the U.S. Food and Drug Administration to treat epilepsy, fibromyalgia and neuropathic pain, such as pain from diabetic neuropathy or pain after shingles or spinal cord injury, according to the prescribing label information. In addition, doctors prescribe it "off label" for anxiety and other mental health problems, the study authors said.