Generic Name: felbamate
Brand Names:
Felbatol
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.)
 | FELBATOL 600 | 04 31 600 mg
bottle, 100 each Felbamate 600mg, Oral tablet, peach, oblong-shaped, scored, side 1:FELBATOL 600, side 2:04 31 |
 | WALLACE | 04 30 400 mg
bottle, 100 each Felbamate 400mg, Oral tablet, yellow, oblong-shaped, scored, side 1:WALLACE, side 2:04 30 |
 | 04 31 | WALLACE 600 mg
bottle, 100 each Felbamate 600mg, Oral tablet, peach, oblong-shaped, scored, side 1:04 31, side 2:WALLACE |
 | FELBATOL 400 | 04 30 400 mg
bottle, 100 each Felbamate 400mg, Oral tablet, yellow, oblong-shaped, scored, side 1:FELBATOL 400, side 2:04 30 |
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