Eslicarbazepine Pregnancy and Breastfeeding Warnings

Eslicarbazepine is also known as: Aptiom

Eslicarbazepine Pregnancy Warnings

Animal studies revealed increased fetal malformations at all doses and fetal growth retardation at the mid and high doses. There are no adequate and well-controlled studies in pregnant women. Eslicarbazepine can significantly decrease the effectiveness of hormonal contraceptives. Female patients of childbearing potential should be advised to use additional or alternative nonhormonal forms of contraception during treatment and after treatment is discontinued for at least one menstrual cycle. Physicians should recommend that pregnant patients taking eslicarbazepine enroll in the North American Antiepileptic Drug Pregnancy Registry. This can be done by calling 1-888-233-2334 (toll-free), and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Potential benefit should outweigh the potential risk.

Eslicarbazepine Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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