Drug Notebook

FDA Alerts

    Aplastic Anemia
  • Risk of aplastic anemia in patients receiving felbamate appears to be at least 40–100 times higher than that in general population (about 2–5 cases per million untreated individuals per year).
  • Potentially fatal; current estimated overall case fatality rate for untreated individuals with aplastic anemia ranges from 20–30%, but rates as high as 70% have been reported in the past.
  • Limit use to patients whose seizure disorder is so severe that the benefits of therapy outweigh the substantial risk of aplastic anemia. (See Seizure Disorders under Uses.)
  • Clinical manifestation of aplastic anemia (e.g., bleeding, infection) usually develops without premonitory clinical or laboratory signs after several months of therapy (range: 5–30 weeks). Routine blood tests are unreliable but may, nevertheless, result in early detection of the syndrome in some patients. (See Hematologic Effects under Cautions.)

    Hepatic Failure
  • Risk of acute hepatic failure resulting in death or hepatic transplantation reported at an estimated rate of about 6 cases per 75,000 patient years of use. Actual rate believed to be considerably higher.
  • Severe hepatic dysfunction followed by hepatic failure reported as early as 3 weeks after initiation of felbamate; has resulted in death or hepatic transplantation in about 67% of reported cases, usually within 5 weeks of the onset of signs and symptoms of hepatic failure. Prodromal symptoms (e.g., anorexia, malaise, other GI symptoms) and/or dark urine may or may not precede onset of jaundice.
  • Do not initiate therapy in patients with active liver disease, abnormal baseline serum transaminase concentrations, or a history of hepatic dysfunction.
  • Periodic serum transaminase testing has not been proven to prevent serious injury but may, nevertheless, result in early detection of the syndrome in some patients. (See Hepatic Effects under Cautions.)

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felbamate
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(fel BAM ate)

What is the most important information I should know about felbamate?

Felbamate can cause a decrease in many types of blood cells (white cells, red cells, platelets). Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, even if these symptoms first occur after you have been using the medication for several months.

Felbamate may also cause liver damage. Call your doctor if you have symptoms such as loss of appetite, stomach pain, or jaundice (yellowing of the skin or eyes).

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking felbamate without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking felbamate suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking felbamate.

Carry an ID card or wear a medical alert bracelet stating that you are taking felbamate, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

What is felbamate?

Felbamate is an anti-epileptic medication, also called an anticonvulsant.

Felbamate is used alone or in combination with other medications to treat seizures in adults with epilepsy. Felbamate is also used to treat children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Felbamate is usually given after other seizure medications have been tried without successful treatment of symptoms.

Felbamate may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking felbamate?

Felbamate can cause serious side effects and is usually given only to people with severe epilepsy when the need for seizure control outweighs the risk of side effects. You may be asked to sign a consent form after you and your doctor have discussed the risks and benefits of taking felbamate.

You should not use this medication if you are allergic to felbamate, or if you have liver disease or a history of blood cell disorders such as anemia.

Before taking felbamate, tell your doctor if you are allergic to any drugs or if you have kidney disease. If you have any of these conditions, you may need a dose adjustment or special tests to safely take felbamate.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category C. Felbamate may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Felbamate can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
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