Vigabatrin Pregnancy and Breastfeeding Warnings

Vigabatrin is also known as: Sabril

Vigabatrin Pregnancy Warnings

To provide information regarding the effects of in utero exposure to vigabatrin, physicians are advised to recommend that pregnant patients taking vigabatrin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Vigabatrin has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of developmental toxicity, including teratogenic effects, an increased incidence of malformations (cleft palate) and embryo-fetal death, decreased fetal body weights, increased incidences of fetal anatomic variations, neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain vacuolation, decreased myelination, and retinal dysplasia) abnormalities. There are no controlled data in human pregnancy. Birth defects have included congenital cardiac defects, congenital external ear anomaly, congenital hemangioma, congenital hydronephrosis, congenital male genital malformation, congenital oral malformation, congenital vesicoureteric reflux, dentofacial anomaly, dysmorphism, fetal anticonvulsant syndrome, hamartomas, hip dysplasia, limb malformation, limb reduction defect, low set ears, renal aplasia, retinitis pigmentosa, supernumerary nipple, and talipes. Vigabatrin should only be given during pregnancy when benefits outweigh risks.

Vigabatrin Breastfeeding Warnings

Vigabatrin is excreted in human milk. Because of the potential for serious adverse reactions from vigabatrin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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