Brand Names: Felbatol, generics
Felbamate (fel BAM ate) has been approved by the FDA as:
Felbamate is not indicated as a first-line antiseizure treatment. The FDA has approved felbamate for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.
Felbamate is available as a tablet and as an oral suspension. Felbamate tablets can be taken with or without food.
If you are allergic to felbamate or any of the inactive ingredients, then you should not take it. Felbamate should not be used in patients with a history of any blood and liver problems.
Other considerations may influence whether you should take felbamate. Tell your healthcare provider if you:
Do not stop taking felbamate suddenly unless directed to do so by your healthcare provider.
As with all antiseizure medications, felbamate should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using felbamate suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking felbamate with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take: other medicines that make you sleepy or dizzy.
Felbamate is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by felbamate can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.
Taking felbamate runs the risk of acute hepatic (liver) failure resulting in death or hepatic transplantation. Call your healthcare provider right away if you have any of these symptoms: yellowing of your skin or the whites of your eyes (jaundice), dark urine, nausea or vomiting, loss of appetite, or pain on the right side of your stomach (abdomen). If you have a history of hepatic dysfunction, you should not take felbamate.
Felbamate may cause serious blood problems (aplastic anemia) that may be life-threatening. The use of felbamate is limited to those whose seizure disorder is so severe that the benefits of therapy outweigh the substantial risk of aplastic anemia. Call your healthcare provider right away if you have any of the following symptoms: fever, sore throat, or other infections that come and go or do not go away; frequent infections or an infection that does not go away; easy bruising; red or purple spots on your body; bleeding gums or nose bleeds; or severe fatigue or weakness.
At this time, there is not enough evidence regarding developmental risks associated with the use of felbamate in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.
If you become pregnant while taking felbamate, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiseizure medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
Felbamate is present in breast milk. It is unknown if there are effects on the breastfed infant, or if felbamate impacts milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for felbamate and the potential effect on the infant from zonisamide or from your epilepsy.
Felbamate may decrease the effectiveness of hormonal contraceptives, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using zonisamide, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.
The most common side effects that were reported in studies of felbamate are:
Studies have found that people who take antiseizure medications including felbamate may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.