Ezogabine Pregnancy and Breastfeeding Warnings

Ezogabine is also known as: Potiga

Ezogabine Pregnancy Warnings

Ezogabine has been assigned to pregnancy category C by the FDA. 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. There are no adequate and well controlled studies in pregnant women. Ezogabine should be given during pregnancy only when benefit outweighs risk. 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 .

Ezogabine Breastfeeding Warnings

There are no data on the excretion of ezogabine into human milk. However, ezogabine and/or its metabolites are present in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants from ezogabine, 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.

See Also...

• ezogabine Consumer Information
• Pregnancy Support Group
• FDA Pregnancy Categories
• Medicine use during Pregnancy
• Medicine use while Breastfeeding
• Safe Medications during Breastfeeding

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