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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 Gabapentin is not generally recommended in pregnancy as there is not enough information about whether it's safe for your baby. However, from the small amount of information that is available, there's no clear evidence that it's harmful. 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 us Can Pregnant Women Take Gabapentin? Animal studies suggest that gabapentin can cause harm on the unborn child therefore should be avoided 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 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. Maternal use of gabapentin, particularly late in pregnancy, was associated with a higher risk of PTB, SGA, and NICUa. The categories were determined by assessing the reliability of documentation and the risk to benefit ratio. These categories did not take into account any risks from pharmaceutical agents or their metabolites in breast milk. In the drug product label, this information was found in the section “Use in Specific Populations”. The former Does taking gabapentin increase the chance of birth defects? Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Small, controlled studies on gabapentin have not suggested an increased chance of birth defects. Does taking gabapentin increase the chance of birth defects? Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Small, controlled studies on gabapentin have not suggested an increased chance of birth defects. 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 Despite the large attenuations from crude to adjusted results, maternal use of gabapentin late in pregnancy, regardless of its use early in pregnancy, remained associated with an approximately 20% to 30% increased risk of preterm birth and a 30% to 40% increased risk of SGA. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or Advice and warnings for the use of Gabapentin during pregnancy. FDA Pregnancy Category C - Risk cannot be ruled out There was a higher risk of preterm birth among women exposed to gabapentin either late (RR, 1.28 [1.08–1.52], p < 0.01) or both early and late in pregnancy (RR, 1.22 [1.09–1.36], p < 0.001), SGA among women exposed to gabapentin early (1.17 [1.02–1.33], p = 0.02), late (1.39 [1.01–1.91], p = 0.05), or both early and late in pregnancy 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 Studies which assessed rates of miscarriage or intrauterine death following gabapentin exposure in pregnancy do not identify an increased risk of these outcomes. Conflicting results regarding a possible increased risk of preterm delivery and low birth weight have been described in a small number of studies but these data may be confounded. 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 Gabapentin exposure during pregnancy did not lead to an increased risk for adverse maternal and fetal events in this study. However, because of the small number of patients examined in this study, additional data from more pregnancies and outcomes are needed.
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