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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. Gabapentin is a medication used for various conditions, but its reproductive safety is not well studied. The web page reviews the available data and reports on the outcomes of 223 pregnancies exposed to gabapentin and 223 unexposed pregnancies. Gabapentin is a drug used to treat epilepsy and neuropathic pain, but its effects on pregnancy and breastfeeding are not well studied. Learn about the potential risks, benefits, and alternatives of using gabapentin during pregnancy and breastfeeding. 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. 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. 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. T1 exposure was defined as pregnancies with at least one filled prescription for gabapentin during the first 90 days of pregnancy (starting from the date of LMP), independently of exposure to gabapentin later in pregnancy. Gabapentin (Neurontin) is a Pregnancy Category C medication that can cause fetal malformation, urinary tract and kidneys problems, and miscarriages. Breastfeeding women should consult their healthcare provider before taking gabapentin as it is excreted into the breast milk and its safety is unknown. 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. We identified 4,642 pregnancies exposed in T1 (mean age = 28 years; 69% white), 3,745 exposed in early pregnancy only (28 years; 67% white), 556 exposed in late pregnancy only (27 years; 60% white), and 1,275 exposed in both early and late pregnancy (29 years; 75% white). Gabapentin is a pregnancy category C drug that may increase the risk of embryo fetal toxicity and preterm birth. Learn about the animal studies, human research, and alternatives for gabapentin use during 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 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 Gabapentin use in pregnancy is not very well-studied. While the available information does not strongly suggest that it causes problems for the baby, further research is required to prove that gabapentin is safe. Gabapentin is a medication used to prevent and control seizures, treat nerve pain, and restless legs syndrome. Learn about the possible risks and benefits of taking gabapentin during pregnancy and breastfeeding, based on available published literature and expert opinions. 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 Does taking gabapentin in pregnancy increase the chance of other pregnancy-related problems? 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. 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 is an antiepileptic drug used for various conditions, but its safety in pregnancy is unclear. A large study found no evidence of major malformations, but increased risk of preterm birth, small for gestational age, and NICU admissions.
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