Felbamate: Consensus of current clinical experience

Epilepsy Research

Volumn 71, Issue 2-3, 2006, Pages 89-101

  Pellock, John M ^a   Faught, Edward ^b   Leppik, Ilo E ^c   Shinnar, Shlomo ^d   Zupanc, Mary L ^e  

^a VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF ALABAMA SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF MINNESOTA   (United States)

^d ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^e MEDICAL COLLEGE OF WISCONSIN   (United States)

Author keywords

Antiepileptic drugs; Aplastic anemia; Felbamate; Hepatic toxicity; Lennox Gastaut syndrome; Refractory epilepsy

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; CARBAMAZEPINE 10,11 OXIDE; CLONAZEPAM; FELBAMATE; GABAPENTIN; LAMOTRIGINE; OXCARBAZEPINE; PHENOBARBITAL; PHENYTOIN; TOPIRAMATE; VALPROIC ACID; VIGABATRIN;

ANOREXIA; APLASTIC ANEMIA; CLINICAL TRIAL; CONSENSUS; DIZZINESS; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG LABELING; DRUG MECHANISM; DRUG WITHDRAWAL; EPILEPSY; EXPERIENCE; HUMAN; INCIDENCE; INSOMNIA; IRRITABILITY; LENNOX GASTAUT SYNDROME; LIVER FAILURE; LIVER TOXICITY; MONOTHERAPY; MORTALITY; NAUSEA; PATIENT MONITORING; PREOPERATIVE CARE; PRIORITY JOURNAL; REVIEW; SEIZURE; SIDE EFFECT;

ANTICONVULSANTS; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; EPILEPSY; HUMANS; LANGUAGE DISORDERS; PHENYLCARBAMATES; PROPYLENE GLYCOLS;

EID: 33748764381     PISSN: 09201211     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eplepsyres.2006.06.020     Document Type: Review

References (56)

1. Beghi E. Efficacy and tolerability of the new antiepileptic drugs: comparison of two recent guidelines. Lancet Neurol. 3 (2004) 618-621
2. Berg A., Shinnar S., Levy S., Testa F., Smith S., and Beckerman B. Mortality in childhood-onset epilepsy. Epilepsia 44 Suppl. 9 (2003) 132
3. Berg A.T., Vickrey B.G., Sperling M.R., Langfitt J.T., Bazil C.W., Shinnar S., Walczak T.S., Pacia S., and Spenser S.S. Driving in adults with refractory localization-related epilepsy. Neurology 54 (2000) 625-630
4. Bourgeois B., Leppik I.E., Sackellares J.C., Laxer K., Lesser R., Messenheimer J.A., Kramer L.D., Kamin M., and Rosenberg A. Felbamate: a double-blind controlled trial in patients undergoing presurgical evaluation of partial seizures. Neurology 43 (1993) 693-696
5. Brodie M.J. Felbamate: a new antiepileptic drug. Lancet 341 (1993) 1445-1446
6. Callenbach P.M.C., Westendorb R.G.J., Geerts A.T., Frans W.N., Peeters E.A.J., van Donselaar C.A., Peters A.C.B., Stroink H., and Brouwer O.F. Mortality in children with epilepsy: the Dutch study of epilepsy in childhood. Pediatrics 107 (2001) 1259-1263
7. Camfield C.S., Camfield P.R., and Veugelers P.J. Death in children with epilepsy: a population-based study. Lancet 43 (2002) 662-663
8. Carmant L., Holmes G.L., Sawyer S., Rifai N., Anderson J., and Mikati M.A. Efficacy of felbamate in therapy for partial epilepsy in children. J. Pediatr. 125 (1994) 481-486
9. Data on File, 2005. MedPointe Pharmaceuticals, Inc.
10. Devinsky O., Faught R.E., Wilder B.J., Kanner A.M., Kamin L.D., and Rosenberg A. Efficacy of felbamate monotherapy in patients undergoing presurgical evaluation of partial seizures. Epilepsy Res. 20 (1995) 241-246
11. Dodson W.E. Felbamate in the treatment of Lennox-Gastaut syndrome: results of a 12-month open-label study following a randomized clinical trial. Epilepsia 34 Suppl. 7 (1993) S18-S24
12. Donner E.J., Smith C.R., and Snead O.C. Sudden unexplained death in children with epilepsy. Neurology 57 (2001) 430-434
13. Faught E., Sachdeo R.C., Remler M.P., Chayasirisobhon S., Iragui-Madoz V.J., Ramsay R.E., Stula T.P., Kanner A., Harner R.N., Kuzniecky R., et al. Felbamate monotherapy for partial-onset seizures: an active-control trial. Neurology 43 (1993) 688-692
14. FDA news web site, August 1, 1994. Letter: Suspension of felbatol use urged. Available at: http://fda.gov/bbs/topics/NEWS/NEW004888.html, Accessed September 7, 2005.
15. Felbatol [product monograph], 2004. Somerset, MedPointe Pharmaceuticals, NJ.
16. Felbatol [package insert], 2003. Somerset, MedPointe Pharmaceuticals, NJ.
17. Ficker D.M., So E.L., Shen W.K., Annegers J.F., O'Brien P.C., Cascino G.D., and Belau P.G. Population-based study of the incidence of sudden unexplained death in epilepsy. Neurology 51 (1998) 1270-1274
18. French J., Smith M., Faught E., and Brown L. Practice advisory: the use of felbamate in the treatment of patients with intractable epilepsy. Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 52 (1999) 1540-1545
19. Glue P., Banfield C.R., Perhach J.L., Mather G.C., Racha J.K., and Levy R.H. Pharmacokinetic interactions with felbamate. Clin. Pharmacokinet. 33 (1997) 214-224
20. Graves N.M., Holmes G.B., Fuerst R.H., and Leppik I.E. Effect of felbamate on phenytoin and carbamazepine serum concentrations. Eoukeosua 30 (1989) 225-229
21. Graves N.M., and Leppik I.E. Advances in pharmacotherapy: recent developments in the treatment of epilepsy. J. Clin. Pharm. Ther. 18 (1993) 227-242
22. Seizures and the developmental disabilities. In: Hauser W.A., and Hesdorffer D.C. (Eds). Epilepsy: Frequency, Causes and Consequences (1990), Demos Publications, New York, NY 327-358
23. Kaufman D.W., Kelly J.P., Anderson T., Harmon D.C., and Shapiro S. Evaluation of cases of aplastic anemia among patients treated with felbamate. Epilepsia 38 (1997) 1265-1269
24. Leppik I.E., Dreifuss F.E., Pledger G.W., Graves N.M., Santilli N., Drury I., Tsay J.Y., Jacobs M.P., Bertram E., Cereghino J.J., Cooper G., Sahlroot J.T., Sheridan P., Ashworth M., Lee S.I., and Siezant T.L. Felbamate for partial seizures: results of a controlled clinical trial. Neurology 41 (1991) 1785-1789
25. Leppik I.E., Erickson D.M., Wolff D.L., Krause S.E., and Gumnit R.J. Present usage of felbamate. Epilepsia 36 Suppl. 4 (1995) 65
26. Leppik I., Kaufman D., Holmes G., Cereghino J., and Costin J. Felbatol (felbamate) review: clinical profile and registry program. Epilepsia 40 Suppl. 2 (1999) 251 (Abstract)
27. Lhatoo S.D., Johnsons A.L., Goodridge D.M., MacDonald B.K., Sander J.W.A.S., and Shorvon S.D. Mortality in epilepsy in the first 11 to 14 years after diagnosis: multivariate analysis of a long-term prospective, population-based cohort. Ann. Neurol. 49 (2001) 344-366
28. Li L.M., Nashef L., Moriarty J., Duncan J.S., and Sander J.W. Felbamate as add-on therapy. Eur. Neurol. 36 (1996) 146-1488
29. Markand O.N. Lennox-Gastaut syndrome (childhood epileptic encephalopathy). J. Clin. Neurophys. 20 (2003) 426-441
30. Neufeld M.Y., Vishne T., Chistik V., and Korczyn A.D. Life-long history of injuries related to seizures. Epilepsy Res. 34 (1999) 123-127
31. Nilsson L., Farahmand B.Y., Persson P.G., Thiblin I., and Tomson T. Risk factors for sudden unexpected death in epilepsy: a case-control study. Lancet 353 (1999) 888-893
32. Pellock J.M. Felbamate in epilepsy therapy: evaluating the risks. Drug Saf. 21 (1999) 225-239
33. Pellock J.M., and Brodie M.J. Felbamate: 1997 update. Epilepsia 38 (1997) 1261-1264
34. Pennel P.B., Ogaily M.S., and Macdonald R.L. Aplastic anemia in a patient receiving felbamate for complex partial seizures. Neurology 45 (1995) 456-460
35. Reidenberg P., Glue P., Banfield C.R., Colucci R.D., Meehan J.W., Radwanski E., Mojavarian P., Lin C.C., Nezamis J., and Guillaume M. Effects of felbamate on the pharmacokinetics of phenobarbital. Clin. Pharmacol. Ther. 58 (1995) 279-287
36. Sachdeo R., Kramer L.D., Rosenberg A., and Sachdeo S. Felbamate monotherapy: controlled trial in patients with partial onset seizures. Ann. Neurol. 32 (1992) 386-392
37. Sachdeo R., Narang-Sachdeo S.K., Shumaker R.C., Perhach J.L., Lyness W.H., and Rosenberg A. Tolerability and pharmacokinetics of monotherapy felbamate doses of 1200-6000 mg/day in subjects with epilepsy. Epilepsia 38 (1997) 887-892
38. Sachdeo R.C., Sachdeo S., and Howard J. Steady-state pharmacokinetics and dose proportionality of felbamate following oral administration of 1200, 2400, and 3600 mg/day felbamate. Epilepsia 34 (1993) 80 (Abstract)
39. Sankar R., and Holmes G.L. Mechanisms of action for the commonly-used antiepileptic drugs: relevance to antiepileptic drug-associated neurobehavioral adverse effects. J. Child Neurol. 19 Suppl. 1 (2004) S6-S14
40. Shackleton D.P., Westendorp R.G.J., Kasteleijn-Nolst Trenite D.G.A., and Vandenbroucke J.P. Mortality in patients with epilepsy: 40 years of followup in a Dutch cohort study. J. Neurol. Neurosurg. Psychiatr. 66 (1999) 636-640
41. Shinnar S., and Pellock J.M. Update on the epidemiology and prognosis of pediatric epilepsy. J. Child Neurol. 17 (2002) S4-S17
42. Sillanpaa M., Jalava M., Kaleva O., and Shinnar S. Long-term prognosis of seizures with onset in childhood. N. Engl. J. Med. 338 (1998) 1715-1722
43. Sofia R.D., Leppik I.E., and Macdonald T.L. Felbamate patient registry. Epilepsia 41 Suppl. 7 (2000) 37
44. Sperling M.R., Feldman H., Kinman J., Liporace J.D., and O'Connor M.J. Seizure control and mortality in epilepsy. Ann. Neurol. 46 (1999) 45-50
45. Swinyard E.A., Sofia R.D., and Kupferberg H.J. Comparative anticonvulsant activity and neurotoxicity of felbamate and four prototype antiepileptic drugs in mice and rats. Epilepsia 27 (1986) 27-34
46. Taloxa [package insert], 2004. Brussels, Belgium: Schering-Plough Europe.
47. The Felbamate Study Group in Lennox-Gastaut Syndrome. Efficacy of felbamate in childhood epileptic encephalopathy (Lennox-Gastaut syndrome). N. Engl. J. Med. 1328 (1993) 29-33
48. Theodore W.H., Raubertas R.F., Porter R.J., Nice F., Devinsky O., Reeves P., Bromfield E., Ito B., and Balish M. Felbamate: a clinical trial for complex partial seizures. Epilepsia 32 (1991) 392-397
49. Wagner M.L., Graves N.M., Leppik I.E., Remmel R.P., Shumaker R.C., Ward D.L., and Perhach J.L. The effect of felbamate on valproic acid disposition. Clin. Pharmacol. Ther. 56 (1994) 494-502
50. Walczak T.S., Leppik I.E., and D'Amelio M. Incidence and risk factors in sudden unexpected death in epilepsy: a prospective cohort study. Neurology 56 (2001) 519-525
51. Welty T.E., Privitera M., and Shukla R. Increased seizure frequency resulting from felbamate withdrawal in adults. Arch. Neurol. 55 (1998) 641-645
52. White H.S. Comparative anticonvulsant and mechanistic profile of the established and newer antiepileptic drugs. Epilepsia 40 Suppl. 5 (1999) S2-S10
53. White J.R., Vaher P., Leppik I.E., and Walczak T.S. Felbamate: clinical and laboratory characteristics in long-term users. Neurology 66 Suppl. 2 (2006) 39 (Abstract)
54. Young N.S. Pathophysiology. II. Immune suppression of haematopoiesis. In: Young N.S., and Alter B.P. (Eds). Aplastic Anemia: Acquired and Inherited (1994), W.B. Saunders, Philadelphia 63-99
55. Zimmerman H.J. Lesions of drug-induced liver disease and valproate hepatotoxicity. In: Levy R.H., and Penry J.K. (Eds). Idiosyncratic Reactions to Valproate: Clinical Risk Patterns and Mechanisms of Toxicity (1991), Raven Press, Ltd., New York 31-45
56. Zupanc M.L., Werner R., and Arentz L. Efficacy of felbamate in the treatment of medically refractory epilepsy in children. Epilepsia 44 (2003) 273 (Abstract)