Pregabalin (marketed in the US as Lyrica) is approved by the US Food and Drug Administration for the treatment of epilepsy, fibromyalgia, and neuropathic pain.  It is also used off-label to treat psychiatric disorders, most commonly generalized anxiety disorder.  While it is not used as frequently as other anti-epileptic drugs, we do occasionally see women taking pregabalin who are pregnant or planning to conceive.  

Last year we reported on a small study which identified an increase in risk of congenital malformations in children exposed to pregabalin during pregnancy.  This multicenter, observational prospective cohort study compared pregnancy outcomes in 164 women exposed to pregabalin to outcomes in 656 matched controls (not exposed to any antiepileptic drugs or known teratogens).  Rates of major birth defects were higher in the pregabalin group than in the non-exposed group (6.0% vs 2.1%; odds ratio 3.0).

A new study was performed using data from the US Medicaid Analytic eXtract (MAX) database. The study population included 1,323,432 pregnancies resulting in a live-born infant, and the researchers examined the risk of major congenital malformations among infants born to women exposed to pregabalin during the first trimester compared with women with no exposure to anticonvulsants.

477 infants were exposed to pregabalin during the first trimester; in this group, 28 (5.9%) had malformations compared to 3.3% in the nonexposed infants. The crude relative risk (RR) of major congenital malformations for pregabalin was 1.80 (95% CI 1.26-2.58).  However, after controlling for potential confounding variable using propensity score adjustment, the RR decreased to 1.16 (95% CI 0.81-1.67). In addition, restricting the analysis to infants exposed to pregabalin monotherapy, the results were similar.  The pooled RR was 1.33 (95% CI 0.83-2.15) for pregabalin any use and 1.02 (95% CI 0.69-1.51) for pregabalin monotherapy.

These findings did not confirm the previous report of teratogenicity for pregabalin, although the authors note that the finding “cannot rule out the possibility of a small effect”.  

Ruta Nonacs, MD PhD


Patorno E, Bateman BT, Huybrechts KF, MacDonald SC, Cohen JM, Desai RJ, Panchaud A, Mogun H, Pennell PB, Hernandez-Diaz S.  Pregabalin use early in pregnancy and the risk of major congenital malformations.  Neurology. 2017 Apr 26.

Winterfeld U, Merlob P, Baud D, Rousson V, et al.  Pregnancy outcome following maternal exposure to pregabalin may call for concern.  Neurology. 2016 May 18.


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