Banzel and Pregnancy

In animal studies on Banzel (rufinamide), large doses caused several problems during pregnancy, such as low fetal weight, skeletal abnormalities, and miscarriages. However, because animals do not always respond to medications in the same way as humans do, your healthcare provider may still recommend the drug if the benefits outweigh the risks. If you are taking Banzel and pregnancy occurs, talk to your healthcare provider.

Banzel Medication Information

Can I Take Banzel During Pregnancy?

Banzel™ (rufinamide) is a prescription medication approved to treat seizures associated with Lennox-Gastaut syndrome. Based on the results of animal studies, Banzel may not be safe for use in pregnant women.

Banzel 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 medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a default pregnancy Category C rating.

When given to rats in pregnancy and while breastfeeding, high doses of Banzel caused the following problems:

Decreased fetal weight
Skeletal abnormalities
Decreased offspring growth and survival.

When given to rabbits during pregnancy, high doses caused the following problems:

Miscarriages
Decreased fetal weight
Abnormalities of the skeleton or internal organs.

However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to pregnant women if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.

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