Zonisamide Pregnancy and Breast Feeding Warnings
Zonisamide is also known as: Zonegran
Overview
Zonisamide may cause harm to the fetus. Do not become pregnant while you are using it. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zonisamide while you are pregnant. It is not known if Zonisamide is found in breast milk. If you are or will be breast-feeding while you use Zonisamide , check with your doctor. Discuss any possible risks to your baby.
Zonisamide Pregnancy Warnings
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.
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. Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.
Zonisamide Lactation 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.
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