Because Inovelon® is relatively new, there is no available information on its safety when taken during pregnancy on the mother or the fetus.

In the United States, the Food and Drug Administration (FDA) assigns each medication to a "Pregnancy Category" according to whether it has been proven to be harmful in pregnancy. Because rufinamide is not approved in the United States as of May 15, 2007, the FDA has not assigned it to a Pregnancy Category.

All women who are capable of becoming pregnant should take the vitamin called folic acid every day because it helps to prevent birth defects called neural tube defects, malformations of the brain or spinal cord. Women with epilepsy who are pregnant or thinking about becoming pregnant should talk to their doctor about the medications they are taking. Because taking more than one seizure medicine may increase the risk of birth defects, doctors sometimes gradually reduce the number or amount of seizure medicines taken by women planning for pregnancy. This is not done routinely, however. The risk of seizures increases when medications are withdrawn, and seizures—particularly complex partial seizures and tonic-clonic seizures—can injure the baby. Because having these types of seizures may harm the baby, it’s important not to stop taking seizure medicines or reduce the amount without the doctor’s OK.

Reviewed by Steven C. Schachter, MD
Submitted: 05/16/07