Pregnant Women: Based on animal data, gabapentin may cause fetal harm (see Pharmacology: Toxicology: Reproduction Studies under Actions). In non-clinical studies in mice, rats and rabbits, gabapentin was developmentally toxic (e.g., increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses lower than the maximum recommended human dose (MRHD) of 3,600 mg/day on a body surface area (mg/m2) basis.
Teratogenic Potential: Gabapentin crosses the human placental barrier. Although there are no adequate and well-controlled studies in pregnant women, congenital malformations and adverse pregnancy outcomes have been reported with gabapentin use; both, from literature and Pregnancy Registries. Since the potential risk for humans is uncertain, gabapentin should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus. If women decide to become pregnant while taking pms-GABAPENTIN, the use of this product should be carefully re-evaluated.
Nursing Women: Gabapentin is excreted in human milk. There are no controlled studies on the effects of gabapentin on breast-fed infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made as to whether to discontinue nursing or to discontinue pms-GABAPENTIN, taking into account the benefit of the drug to the mother.