Zonisamide Pregnancy and Breastfeeding Warnings

Zonisamide is also known as: Zonegran

Zonisamide Pregnancy Warnings

Although the effects of metabolic acidosis from zonisamide on the fetus are not clearly known, metabolic acidosis in pregnancy (due to other causes) may affect fetal development (i.e., decreased fetal growth, decreased fetal oxygenation and fetal death) and the ability of the fetus to tolerate labor. To provide information regarding the effects of in utero exposure to zonisamide, physicians are advised to recommend that pregnant patients taking zonisamide 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/.

Zonisamide has been assigned to pregnancy category C. Animal studies have revealed evidence of teratogenicity. Fetal abnormalities or embryo-fetal deaths have been reported in animal tests at zonisamide dosage and maternal plasma levels similar to, or lower than human therapeutic levels. Therefore, use of this drug in human pregnancy may expose the fetus to significant risk. There are no controlled data in human pregnancy. Zonisamide is only recommended for use during pregnancy if potential benefits are felt to outweigh potential risks.

Zonisamide Breastfeeding Warnings

There are no data on the excretion of zonisamide into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from zonisamide, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Significant amounts of zonisamide can appear in the breast milk of nursing women taking zonisamide, and the effects of this exposure on the infant from metabolic acidosis, or any other cause, are unknown.

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