Lyrica, also known by its generic name pregabalin, is used to treat neuropathic pain, fibromyalgia, seizures and anxiety disorders. The journal Neurology recently published a study evaluating the use of pregabalin during pregnancy, and found that exposure was linked to a higher rate of major birth defects (MBD) and a lower rate of live births. According to PracticalPainManagement.com, little research has been done on the effects of in-utero exposure to pregabalin.
“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.
The study was led by Ursula Winterfeld, PhD, who researched Lyrica as part of the European Network of Teratology Information Services (ENTIS). ENTIS provides information about drug interactions and drug safety. It’s goal is to provide reassurance about the known safety of a drug. “This why we did not necessarily expect these study results, even though other antiepileptic drugs have been shown to be teratogenic,” Dr. Winterfeld told Practical Pain Management.
The study collected data from 164 pregnancies in which Lyrica was used during the first trimester. Data on 656 controls was also gathered for comparison. 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.”
The findings prompted the authors to suggest caution in 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.
The study had limitations. 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 an Increased rates of spontaneous abortions.