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This article summarizes the current literature regarding gabapentin use during pregnancy and related prenatal and neonatal exposure outcomes with special consideration for interactions between gabapentin and opioid use. While gabapentin (Neurontin) is now used in a wide variety of clinical settings — for epilepsy, pain management, restless leg syndrome, anxiety, and sleep disturbance – there is relatively little information regarding its reproductive safety. Most recently, a prospective study from researchers at the Motherisk program reports on the outcomes of 223 pregnancies exposed to gabapentin Selected References: Blotiere PO, et al. 2020. Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy: a French nationwide population-based cohort study. BMJ Open 10(6). Brannon GE, Rolland PD. Anorgasmia in a patient with bipolar disorder type 1 treated with gabapentin. J Clin Psychopharmacol. 2000;20(3):379 If you're trying to get pregnant or have become pregnant while taking gabapentin, it is recommended to take a high dose of folic acid (5mg a day). You can get this from your doctor or midwife. Ideally you'll take high dose folic acid for 3 months before you start trying to get pregnant and for the first 12 weeks of pregnancy. In a cohort study of pregnant women included in the US Medicaid Analytic eXtract (MAX) dataset, Elisabetta Patorno and colleagues investigate neonatal and maternal outcomes associated with gabapentin exposure during pregnancy. This sheet is about exposure to gabapentin in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider. Pregnancy categories A, B, C, D and X are being phased out. -Breastfed infants should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially when used in combination with other anticonvulsant or psychotropic drugs and in younger, exclusively breastfed infants. Medications approved prior to June 29, 2001 are not subject to the PLLR rule; however, the pregnancy letter category must be removed by June 29, 2018. For generic drugs, if the labeling of a reference listed drug is updated as a result of the final rule, the abbreviated new drug application (ANDA) labeling must also be revised. In this large population-based study, we did not find evidence for an association between gabapentin exposure during early pregnancy and major malformations overall, although there was some evidence of a higher risk of cardiac malformations. Maternal use of gabapentin, particularly late in pregnancy All pregnant women in the UK will be offered a very detailed anomaly scan at around 20 weeks of pregnancy as part of their routine antenatal care. No extra monitoring for major birth defects is required following gabapentin use in pregnancy. Babies exposed to gabapentin before delivery may experience withdrawal symptoms for a few days after birth. The researchers reported 2 major malformations in infants exposed to gabapentin in the first trimester of pregnancy. 3 In another group of 7 women with hyperemesis gravidarum, 2 congenital defects were reported. 4 A cohort study in Denmark reported on 59 fetuses exposed to gabapentin during pregnancy, and documented 1 major malformation and 6 We examined the risk of major congenital malformations and cardiac defects associated with gabapentin exposure during the first trimester (T1), and the risk of preeclampsia (PE), preterm birth (PTB), small for gestational age (SGA), and neonatal intensive care unit admission (NICUa) associated with gabapentin exposure early, late, or both early Gabapentin is a pregnancy category C, which means risk cannot be ruled out. Does gabapentin cause birth defects? There is currently not enough data to determine the risk of major birth defects in humans. Gabapentin is a γ-aminobutyric acid analog formally indicated for the treatment of epilepsy and neuropathic pain that is gaining increased popularity. Gabapentin has been historically considered a safe medication, including during pregnancy and lactation, with low reported concerns for misuse and use disorders. The objective of this study was to assess the safety of gabapentin (Neurontin) exposure in human pregnancy. Prospective and retrospective data concerning 51 fetuses, including 3 twin gestations, were collected from 39 women with epilepsy and other disorders exposed to gabapentin during pregnancy. The U.S. Food and Drug Administration classifies gabapentin (Neurontin) as a Pregnancy Category C medication, which means that animal studies conducted on this medication has caused harm on the fetus. It is not known if gabapentin can make it harder to get pregnant. Sexual dysfunction (including loss of desire to have sex and loss of ability to have an orgasm) has been reported among women who take gabapentin. This sheet is about exposure to gabapentin in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider. 4,642 pregnancies with first trimester gabapentin exposure were identified (mean age of 28 years; 69% white). A reference group consisting of 1,744,447 unexposed pregnancies (mean age of 24 years; 40% white) was also identified.
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