Update Regarding AEDs and Pregnancy: Pregabalin (Lyrica®) May Increase Risk of Birth Defects

Pregnant Woman
  • A June 2016 study offers new insight to the potential risks of pregabalin (Lyrica®) in women of child bearing age.
  • The study found that rate of major birth defects was higher and the rate of live births was lower in the pregabalin-exposed group.
  • It is important to keep in mind that there significant limitations in the study, including that the risk of not taking medication was not studied.

Epilepsy News From:

Tuesday, July 26, 2016

A study published in the June issue of Neurology, “Pregnancy outcome following maternal exposure to pregabalin may call for concern,” offers new insight to the potential risks of pregabalin (Lyrica®) in women of child bearing age. The goal of the study was to determine if use of pegabalin during pregnancy increased the risk of adverse pregnancy outcomes or birth defects in babies exposed to the drug. This was a multicenter, prospective, observational study – the authors followed women over time and collected data about what happened during that time period.

Summary of Study Methods

  • The study was conducted at many sites with data collected between 2004 and 2013 in France, United Kingdom, Italy, Finland, Switzerland, the Netherlands, and Turkey.
  • 163 women taking pregabalin during pregnancy and 656 controls (women who were not taking any seizure medications or other medications known to cause birth defects) were followed over time.
  • The median or average daily dose of pregabalin in the exposed group (women taking the drug) was 150mg (range 75 to 300mg).
  • The vast majority of women were taking pregabalin for reasons other than epilepsy: 115 were taking it for neuropathic pain, 39 for psychiatric disorders, 5 for epilepsy, and 1 for restless leg syndrome.

Main Results

  • The rate of major birth defects was higher in the pregabalin-exposed group.
    • Major birth defects occurred in 7 out of 116 or 6% of women taking pregabalin during pregnancy as compared to 12 out of 580  or 2.1% in the control group of women not taking pregabalin. This gives an odds ratio of 3.0.
    • The difference persisted after excluding birth defects from chromosomal aberration syndromes (which would not be related to medication exposure).
  • The rate of live births was lower in the pregabalin group.
    • Fewer pregnancies were carried to term in the women taking pregabablin (71.9%) than in those not taking the medication (85.2%).
    • There was no difference in risk of spontaneous abortion.

Important Points to Consider

  • The authors point out significant limitations in the interpretation of their data, particularly the fact that the two groups (exposed vs. control) were not sufficiently “matched” to make definitive conclusions.
  • Most importantly, the control women, or those not taking pregabalin, were not being treated for similar conditions as the women taking pregabalin.
  • Most of the pregabalin-exposed women were taking other medications (for instance other seizure medications and antidepressants). When the analysis was limited to women taking ONLY pregabalin, the difference in the rate of major birth defects disappeared when chromosomal/genetic anomalies were excluded.

Bottom line

Results from this study suggest that women taking pregabalin during the first trimester of pregnancy are at a higher risk of having a child with birth defects, but additional studies are needed for confirmation. The risk is still low at 6%. The risks of not taking the medication were not considered in this study. Pregabalin or any seizure medication should not be stopped abruptly or changed without the advice of the treating health care provider.


Ursula Winterfeld, Paul Merlob, David Baud, et al. 2016. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology 86:1-67.

Authored by: Kristine Ziemba MD, PhD | PhD | Gender Issues Editor on 7/2016

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