Potential maternal symptomatic benefit of gabapentin and review of its safety in pregnancy.

Restless legs syndrome (RLS) and nausea and vomiting of pregnancy (NVP) are both common maternal conditions affecting quality of life. Gabapentin is currently FDA-approved for treating RLS and preliminary results have shown it may be effective for treating the most severe form of NVP, hyperemesis gravidarum (HG). Because NVP and HG symptoms peak early in pregnancy, the potential teratogenicity of gabapentin needs to be considered. We reviewed published pregnancy registries and cohorts for pregnancy outcomes associated with maternal gabapentin use. Gabapentin exposures from 5 pregnancy registries, 1 HG pilot study and 2 additional cases were reviewed. Among 294 first trimester gabapentin-monotherapy exposures, there were 5 major congenital malformations (MCMs) reported (1.7%), which favorably compares to the MCM rate in the general population (1.6-2.2%). Two of the registries reported maternal gabapentin use among 261 singleton pregnancies to be associated with roughly equivalent rates of premature birth, birth weight after correction for gestational age at delivery and maternal hypertension/eclampsia as those that have been reported in the general population. These data support the safety of gabapentin use in pregnancy; however, the number of exposures to date is still small. If future pregnancy registry data confirm this positive safety profile, gabapentin therapy would likely be a safe and effective treatment for RLS during pregnancy. Controlled, clinical trials are needed to assess gabapentin's effectiveness for HG.