Ezogabine Pregnancy and Breastfeeding Warnings

Ezogabine is also known as: Potiga

Ezogabine Pregnancy Warnings

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

There are no adequate and well controlled studies in pregnant women. Doses associated with maternal plasma exposures (AUC) to ezogabine and its major circulating metabolite, NAMR, similar to or below those expected in humans at the maximum recommended human dose (MRHD) of 1,200 mg/day produced developmental toxicity when administered to pregnant rats and rabbits. Physicians should recommend that pregnant patients taking ezogabine enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry to provide information regarding the effects of in utero exposure. 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 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.

Ezogabine 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: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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