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It’s important to know the pregnancy category of any medications you may be taking. Gabapentin, a medication commonly used to treat epilepsy and neuropathic pain, falls into category C for pregnancy. Category C means that animal studies have shown adverse effects on the fetus, but there are no well-controlled and adequate studies in humans. 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 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. 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. Does taking gabapentin increase the chance of miscarriage? 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. Despite the widespread use, only sparse information is available on the safety of gabapentin during pregnancy. We sought to evaluate the association between gabapentin exposure during pregnancy and risk of adverse neonatal and maternal outcomes. To provide evidence on the safety of gabapentin use in pregnancy, we conducted a large cohort study of pregnant women within the US Medicaid Analytic eXtract (MAX) and assessed a range of neonatal and maternal outcomes. 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. NEURONTIN safely and effectively. See full prescribing information for NEURONTIN. NEURONTIN ® (gabapentin) capsules, for oral use NEURONTIN ® (gabapentin) tablets, for oral use NEURONTIN ® (gabapentin) oral solution Initial U.S. Approval: 1993 ----- Warnings and Pr ecautions, Respiratory Depression (5.7) 04/2020 Pregnancy-related problems, such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth) have been reported in some studies looking at the use of gabapentin during pregnancy. Advice and warnings for the use of Gabapentin during pregnancy. FDA Pregnancy Category C - Risk cannot be ruled out 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 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. 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. 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 Pregnancy-related problems, such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth) have been reported in some studies looking at the use of gabapentin during pregnancy. Is gabapentin dangerous in pregnancy? Because the risks of taking gabapentin while pregnant in humans are not fully understood, use of gabapentin during pregnancy is determined on a case-by-case basis to determine if the benefits outweigh the risks. Gabapentin is a pregnancy category C, which means risk cannot be ruled out.
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