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Rufinamide Pregnancy and Breastfeeding Warnings

Rufinamide is also known as: Banzel

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Rufinamide while you are pregnant. Rufinamide is found in breast milk. Do not breast-feed while taking Rufinamide.

Rufinamide Pregnancy Warnings

Rufinamide has been assigned to pregnancy category C by the FDA. Animal studies have revealed embryofetal death, decreased fetal body weights, decreased offspring growth and survival, and increased incidences of fetal visceral and skeletal abnormalities. There are no controlled data in human pregnancy. Rufinamide should only be given during pregnancy when benefits outweigh risks. To provide information regarding the effects of in utero exposure to rufinamide physicians are advised to recommend that pregnant patients taking rufinamide enroll in the North American Antiepileptic Drug 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/.

Oral administration of rufinamide to male and female animals prior to mating and throughout mating, and continuing in females up to day 6 of gestation resulted in impairment of fertility (decreased conception rates and mating and fertility indices; decreased numbers of corpora lutea, implantations, and live embryos; increased preimplantation loss; decreased sperm count and motility at all doses tested. Therefore, a no-effect dose was not established.

Rufinamide Breastfeeding Warnings

There are no data on the excretion of rufinamide into human milk. However, the manufacturer has stated that rufinamide is likely to be excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from rufinamide, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

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