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The Risk of Congenital Malformations Associated with First Trimester Gabapentin Use
Abstract Number: O2-1
Abstract Type: Original Research
Background: Gabapentin is an anticonvulsant drug commonly used in the U.S. for the treatment of neuropathic pain. Despite the increasing number of patients receiving gabapentin(1), information on the safety of this medication during pregnancy is limited to small cohort studies and registries(2-3). Safety data are important not only in guiding whether the medication can be used during pregnancy, but also to determine whether it can be safely used in women of reproductive age who may inadvertently become pregnant while taking the drug.
Objective: To assess the risk of major congenital malformations associated with maternal use of gabapentin.
Methods: The cohort included 1,749,089 women who delivered a liveborn infant during 2000-2013 and were enrolled in Medicaid from 3 months before conception to 1 month after delivery. We examined the risk of major congenital malformations (identified through highly specific definitions based on inpatient or outpatient diagnosic and procedure codes) among women with 1st trimester pharmacy dispensing of gabapentin compared to unexposed women. Fine stratification on the propensity score (PS) was used to control for over 50 potentially confounding baseline characteristics, including maternal demographics, medical comorbidities, co-medications, and indications for gabapentin use (4). Relative risks (RR) and 95% confidence intervals (CI) were estimated in weighted generalized linear models. Multiple sensitivity analyses were conducted.
Results: During the first trimester, 4,642 women filled ≥1 prescription for gabapentin. The frequency of first trimester gabapentin exposure increased from 1.2 per 1,000 pregnancies in 2000 to 6.0 per 1,000 in 2013. Overall, the prevalence of malformations was 3.33% for unexposed infants and 4.95% for infants exposed in-utero to gabapentin.
The unadjusted relative risk (RR) for major congenital malformations associated with gabapentin exposure was 1.49 (95% confidence interval (CI), 1.31 to 1.69). The RR attenuated after controlling for confounders with PS-adjustment to 1.07 (95% CI, 0.94 to 1.21). The unadjusted RR for the most common class of malformations, cardiac malformations, was 1.77 (95% CI, 1.43 to 2.18) and the PS-adjusted RR was 1.12 (95% CI, 0.89 to 1.40).
Conclusions: Results from this large cohort study suggest that, after controlling for confounding factors, gabapentin was not associated with an increased risk of major congenital malformations overall or cardiac malformations. While these results provide important reassurance to patients and practioners regarding the risks of gabapentin use during early pregnancy, additional safety data are needed regarding the potential impact on other pregnancy-related complications and long-term developmental outcomes.
(1) N Engl J Med. 2017 Aug 3;377(5):411-414
(2) Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:280-3
(3) Neurology. 2013 Apr 23;80(17):1565-70
(4) Epidemiology. 2017 Mar;28(2):249-257