Epilepsy Home > Felbatol and Pregnancy
When large doses of Felbatol (felbamate) were used in animal studies, the medication did appear to cause reduced offspring growth and survival. Due to the potential risks, Felbatol is considered a pregnancy Category C medication, meaning it may not be safe for pregnant women. However, your healthcare provider may still recommend the drug if the benefits outweigh the risks.
Can Pregnant Women Take Felbatol?Felbatol® (felbamate) is a prescription medication used to control seizures in people with epilepsy. Based on the results of animal studies, it may not be safe for pregnant women to take this medication.
What Is 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 do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
In studies, giving high doses of Felbatol to pregnant rats and rabbits did not cause any problems in the offspring. However, giving high doses of Felbatol to mother rats while breastfeeding caused reduced offspring growth and survival.
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 a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.