Study Shows Lyrica Linked to Major Birth Defects

New research has linked the medication Lyrica with birth defects in the babies of pregnant woman who take the drug.

Lyrica (pregabalin) is prescribed to treat seizures, neuropathic pain, fibromyalgia, anxiety disorders, psychiatric conditions, and restless leg syndrome. But there is little research on the safety of Lyrica for pregnant women, and a new study suggests an increased risk of birth defects when the drug is taken during pregnancy, Practical Pain Management reports.

The researchers collected data from 164 pregnancies in which patients took Lyrica during the first trimester and they compared these to 656 controls (women who did not take the drug). The women who took Lyrica during pregnancy showed a higher rate of major birth defects, and a lower rate of live births, primarily due to elective and medically indicated pregnancy terminations, according to Practical Pain Management. The authors say this is the largest report yet published on “pregnancy outcomes after in utero exposure to pregabalin.”

Earlier animal studies have found evidence suggesting Lyrica may be harmful to the fetus’s development. Documented birth defects include:

  • skeletal malformations
  • neural tube defects
  • growth retardation
  • behavioral anomalies
  • increased rates of spontaneous abortions (miscarriage)

A recent database study of 30 pregabalin exposures documented a major malformation observed in one infant. Such findings are limited by the small sample size, but similar concerns have been expressed over gabapentin (Neurontin), another anti-seizure medication that has been associated with an increased risk of low birth weight and premature births in women who took the drug during pregnancy.

The lead author the new study, Ursula Winterfeld, PhD, was researching the drug as part of the European Network of Teratology Information Services (ENTIS), a resource for patients and doctors providing information on drug-drug interactions and drug safety. ENTIS research aims to provide reassuring evidence of a drug’s known safety, Practical Pain Management notes.

In the new study, researchers gather patient data from ENTIS for patients based mostly in the United Kingdom, France, Italy, Finland, Switzerland, the Netherlands, and Turkey. The researchers assessed such maternal factors as tobacco and alcohol use, medical and obstetrical records, and previous and current medication exposure. The researchers excluded subjects who had been exposed to major teratogens (agents that can cause birth defects) or substances that might be toxic to the fetus, or women who had been treated for a malignancy.

The researchers found that of the 164 women who took pregabalin during pregnancy, 98 percent were taking Lyrica for pain, mostly neuropathic pain (115). Seventy-seven percent of the patients had been taking pregabalin before pregnancy and subsequently discontinued use at about six weeks. Major birth defects occurred “more frequently in pregnancies exposed to pregabalin than in the control group,” the researchers noted, according to Practical Pain Management.

Given these results, the researchers say Lyrica should be prescribed in women of childbearing age only “on a valid indication and after thorough risk-benefit analysis.” Enhanced fetal monitoring “may be warranted” for patients who do take pregabalin during pregnancy. The monitoring could include a detailed ultrasound examination. Dr. Winterfeld told Practical Pain Management that “effective contraception” should be advised when prescribing pregabalin to a woman of childbearing age, and Lyrica use must be “carefully re-examined in cases of desired or established unexpected pregnancy.”


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