title: Evaluating the safety and efficacy of felbamate in the context of a black box warning: A single center experience.
abstract: BACKGROUND
  Felbamate was approved in 1993 to treat partial seizures with and without secondary generalization in adults and in Lennox-Gastaut Syndrome in children. Its use was later restricted when rare but fatal cases of aplastic anemia and hepatic failure were identified.
  
  
  METHODS
  This single center analysis retrospectively evaluated the safety and efficacy of felbamate in a cohort of children, adolescents, and adults with epilepsy.
  
  
  RESULTS
  A chart review identified 103 patients taking felbamate. The range of felbamate dose was 300-4500 mg (mean: 1800 ± 900 mg). The duration of therapy ranged from 1 month to 20 years (mean duration: 35 ± 45 months). Eighteen (17.5%) subjects experienced adverse events including insomnia, nausea, vomiting, decreased appetite, weight loss, gastric discomfort, diarrhea, mood and behavioral problems, high blood pressure, headache, and elevated liver enzymes. Out of these, 6 (5.9%) patients discontinued the therapy. No hepatic failure or agranulocytosis was observed. Fifty-nine (57.72%) patients achieved ≥ 50% reduction in seizure frequency, and 30 (29.12%) patients achieved seizure freedom.
  
  
  CONCLUSIONS
  These findings suggest that felbamate is safe, well tolerated, and effective in treatment of various types of epilepsy syndromes.
authors.affiliation: Department of Neurology, NYU Langone Medical Center, USA.
authors.forename: Yash D
authors.initials: YD
authors.lastname: Shah
authors.affiliation: Division of Pediatric Neurology, University of Massachusetts Medical School, USA.
authors.forename: Kanwaljit
authors.initials: K
authors.lastname: Singh
authors.affiliation: Department of Neurology, NYU Langone Medical Center, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Friedman
authors.affiliation: Department of Neurology, NYU Langone Medical Center, USA.
authors.forename: Orrin
authors.initials: O
authors.lastname: Devinsky
authors.affiliation: Department of Neurology, NYU Langone Medical Center, USA. Electronic address: sanjeev.kothare@nyumc.org.
authors.forename: Sanjeev V
authors.initials: SV
authors.lastname: Kothare
mesh_terms: D000293:Adolescent; D000328:Adult; D017668:Age of Onset; D000741:Anemia, Aplastic / Q000139:chemically induced; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D015331:Cohort Studies; D004348:Drug Labeling; D004827:Epilepsy / Q000188:drug therapy*; D000078328:Felbamate; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D048448:Phenylcarbamates / Q000009:adverse effects* / Q000627:therapeutic use*; D011409:Propylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use*; D012189:Retrospective Studies; D012640:Seizures / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D048448:Phenylcarbamates; D011409:Propylene Glycols; D000078328:Felbamate
keywords: Adverse events; Aplastic anemia; Felbamate; Hepatic; Safety