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felbamate Images

Generic Name: felbamate

Brand Names: Felbatol

There is an FDA Alert for this drug. Click here to view it.

    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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