Animal studies on Zonegran and pregnancy showed that when it was given to pregnant rats, mice, and dogs, the drug increased the risk of birth defects, including heart defects. When given to pregnant monkeys, it increased the risk of miscarriages. Therefore, the FDA has classified it as a pregnancy Category C medication. If you are taking Zonegran and pregnancy occurs, talk to your healthcare provider.
Is Zonegran Safe During Pregnancy?
Zonegran® (
zonisamide) may not be safe for use during pregnancy. In animal studies that evaluated the effects of Zonegran use during pregnancy, the drug increased the risk of birth defects and miscarriages.
Zonegran and Pregnancy Category C
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medications that have not been studied in pregnant humans but that appear to cause harm to the fetus in animal studies. Also, medications that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Zonegran was assigned a pregnancy Category C rating due to problems in animal studies. When given to pregnant rats, mice, and dogs, the drug increased the risk of birth defects, including heart defects. When given to pregnant monkeys, Zonegran increased the risk of miscarriages.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. Zonegran may not be the best choice for pregnant women with
epilepsy, as it is intended to be used only in combination with other
seizure medications. It is generally accepted that taking a single seizure medication (rather than two or more) is best for pregnant women.
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