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Gabapentin in pregnancy and the risk of adverse neonatal and maternal outcomes: A population-based cohort study nested in the US Medicaid Analytic eXtract dataset

PLoS Medicine Sep 05, 2020

Patorno E, Hernandez-Diaz S, Huybrechts KF, et al. - Gabapentin has currently been approved by US Food and Drug Administration (FDA) for the treatment of partial seizures and postherpetic neuralgia, and is used extensively off-label for many conditions, including neuropathic pain, fibromyalgia, anxiety, and tremor. Researchers sought to ascertain the safety of gabapentin during pregnancy via examining if gabapentin exposure during pregnancy is associated with risk of adverse neonatal and maternal outcomes. A population-based study of 1,753,865 Medicaid-eligible pregnancies between January 2000 and December 2013 was performed using the United States Medicaid Analytic eXtract (MAX) dataset. Among these, 4,642 pregnancies had first trimester (T1) exposure (mean age = 28 years; 69% white), 3,745 had exposure in early pregnancy only (28 years; 67% white), 556 had exposure in late pregnancy only (27 years; 60% white), and 1,275 had exposure in both early and late pregnancy (29 years; 75% white). The reference group comprised 1,744,447 unexposed pregnancies (24 years; 40% white). Findings suggest no association between gabapentin exposure during early pregnancy and major malformations overall, although some evidence of a higher risk of cardiac malformations was gained. Maternal use of gabapentin, particularly late in pregnancy, was linked with a higher risk of preterm birth, small for gestational age, and neonatal intensive care unit admission.

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