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Lyrica Linked to Birth Defects

Jun 16, 2016

A study published in the journal Neurology links Lyrica (generic: pregabalin) to an increased risk of major birth defects and a lower rate of live births. The medication is used to treat neuropathic pain, fibromyalgia, seizures and anxiety disorders. The researchers, led by Ursula Winterfeld, PhD, point to the lack of research on Lyrica use during pregnancy. "To our knowledge, this prospective observational study reporting on pregnancy outcomes after in utero exposure to pregabalin is the largest report published yet," the researchers said.

Researchers gathered data on 164 pregnancies in which Lyrica was used during the first trimester and 656 controls. Exposure to pregabalin was associated with a higher rate of MBD and a lower rate of live births, mostly due to elective and medically-indicated pregnancy terminations.

"Altogether, MBD were reported more frequently in pregnancies exposed to pregabalin than in the control group," the authors said. This link persisted even when the authors accounted for chromosomal aberration syndromes. "The rate of live births was lower in the pregabalin group, primarily due to a higher rate of both elective and medical pregnancy terminations. The crude spontaneous abortion rate was also higher in the pregabalin group."

Dr. Winterfeld researched Lyrica as part of the European Network of Teratology Information Services (ENTIS). She told Practical Pain Management that "... we did not necessarily expect these study results, even though other antiepileptic drugs have been shown to be teratogenic," because ENTIS intends to provide reassurance about the known safety of a drug.

The outcome of the study prompted the authors to advise caution when prescribing Lyrica to pregnant women. "pregabalin should only be prescribed in women of childbearing age on a valid indication and after thorough risk-benefit analysis. In patients exposed to pregabalin during pregnancy, enhanced fetal monitoring may be warranted," they stated.

"In patients of childbearing age, effective contraception should be advised when prescribing pregabalin, and its indication must be carefully re-examined in cases of desired or established unexpected pregnancy," Dr. Winterfeld said to Practical Pain Management.

There were limitations to the study. For example, the MBD risk was higher among women who reported smoking before pregnancy. However, previous studies have suggested evidence of birth defects associated with Lyrica, including skeletal malformations, neural tube defects, growth retardation, behavioral anomalies and increased rates of spontaneous abortions.

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