Felbamate for partial seizures

Leppik, Ilo E.; Dreifuss, Fritz E.; Pledger, Gordon; Graves, Nina M.; Santilli, Nancy; Drury, Ivo; Tsay, Jia-Yeong; Jacobs, Margaret P.; Bertram, Edward H.; Cereghino, James J.; Cooper, Gregory; Sahlroot, J. T.; Sheridan, Philip H.; Ashworth, M. R.; Lee, S. I.; Sierzant, Tess

doi:10.1212/wnl.41.11.1785

Cited by 165 publications

(63 citation statements)

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“…2,3 In both the adult and pediatric population, concomitant AEDs should be reduced by a minimum of 20% when starting felbamate, and may be reduced further if levels are high. 1 Felbamate is generally well tolerated, with the most common adverse effects being insomnia, dizziness, fatigue, decreased appetite, weight loss, nausea, ataxia, and lethargy.…”

Section: Felbamatementioning

confidence: 99%

“…1 Felbamate is generally well tolerated, with the most common adverse effects being insomnia, dizziness, fatigue, decreased appetite, weight loss, nausea, ataxia, and lethargy. [2][3][4][5] In 110,000 patients, there were 10 cases of fatal aplastic anemia and 14 cases of fatal hepatic failure. The labeling was changed to advise that it be utilized in a limited subset of patients along with bi-weekly blood monitoring.…”

Section: Felbamatementioning

confidence: 99%

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New Add-on Therapy for Partial-onset Epilepsy

Levine¹,

Ko²

2008

US Neurology

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Section: Felbamatementioning

confidence: 99%

Section: Felbamatementioning

confidence: 99%

New Add-on Therapy for Partial-onset Epilepsy

Levine¹,

Ko²

2008

US Neurology

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“…Though its exact mechanism of action is undefined, predinical evaluations have indicated that felbamate appears to increase seizure threshold and prevent seizure spread (65). In controlled clinical studies, felbamate has demonstrated efficacy as adjunctive therapy in the treatment of partial and generalired seizures in adults (66)(67)(68). In addition, felbamate as monotherapy was superior to a nontherapeutic dose of valproic acid (69,70).…”

Section: New Antiepileptic Medicationsmentioning

confidence: 99%

Advances in pharmacotherapy: recent developments in the treatment of epilepsy

Graves

Leppik

1993

J Clin Pharm Ther

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SUMMARY Epilepsy is a disorder of the central nervous system in which the clinical symptoms are recurrent seizures. An increased understanding of the underlying mechanism of seizures and more definitive diagnostic procedures have improved the care of the patient with epilepsy. An improved classification of various seizure types, including specific epilepsy syndromes has helped optimize use of the standard antiepileptic drugs. Research on the mechanism of seizures has led to new antiepileptic drugs. More definitive diagnostic procedures have led to more accurate identification of patients likely to benefit from epilepsy surgery. This review focuses on these areas.

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“…The efficacy of FBM was shown in trials in which FBM was added to phenytoin (PHT) and carbamazepine (CBZ) in patients with partial epilepsy ( 17), patients with partial seizures who were undergoing presurgical evaluation ( 18), and as monotherapy in uncontrolled partial epilepsy (19). The approval in children was primarily based on a multicenter study of 73 patients with LennoxGastaut syndrome that compared the efficacy of FBM to that of placebo as adjunctive therapy to concurrent AEDs (20).…”

mentioning

confidence: 99%

Felbamate

Pellock

1999

Epilepsia

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Summary: Felbamate (FBM) was the first of the new antiepileptic drugs (AEDs) approved in the United States in 1993 with broad-spectrum efficacy against partial and generalized seizures of various types, and indicated for use as adjunctive and monotherapy. The identification of idiosyncratic aplastic anemia and hepatotoxicity, however, drastically curtailed its use. To update information concerning FBM and its idiosyncratic effects, case studies and literature reviews were undertaken. Thirty-four FBM-associated aplastic anemia patients have been reported, with 13 known fatalities. The overall FBM aplastic anemia risk is estimated at between 27 and 209 per million vs. 2 to 2.5 per million in the general population. Prior AED hypersensitivity, cytopenia, and immune disease significantly increase risk. FBM aplastic anemia has not been reported in children below the age of 13 years. Hepatic failure is much less common, occurring with an overall risk similar to that associated with valproate, but children below the age of 5 years have been affected. The recent identification of a reactive metabolite, atropaldehyde, and HLA studies suggest that high-risk patients can be identified. The efficacy profile of FBM should encourage further investigations to allow its better use, but at present FBM is not a first-line AED. Key Words: Felbamate-Idiosyncratic reactions-Atropaldehyde-Risk factors-Aplastic anemia.Felbamate (FBM) led the introduction of the new antiepileptic drugs (AEDs) and is truly unique. It has a broad spectrum of control on multiple seizure types, particular efficacy in refractory patients, a relative lack of central nervous system depressant effects, and a relative paucity of typical adverse events associated with its use (1,2). Despite the identification of rare but lifethreatening idiosyncratic reactions, FBM continues to be used, albeit with caution, in patients who are refractory to other medications. Moreover, with the failure of other therapies, FBM is again being considered as a therapeutic agent.FBM was the first of the new AEDs to be approved in the United States after a gap of nearly 15 years. Initially marketed in early 1993, FBM is indicated for monotherapy and adjunctive therapy in the treatment of partial seizures with or without generalization in adults, or as adjunctive therapy in the treatment of partial and generalized seizures associated with the Lennox-Gastaut syndrome in children (3). The identification of aplastic anemia and hepatotoxicity associated with FBM, however, drastically curtailed its use despite its broad spectrum of activity and particularly its efficacy in controlling encephalopathic epilepsy syndromes of childhood (4). It is now considered a third-or fourth-line drug and is prescribed primarily for those with truly intractable epilepsy (4).The clinical development program for FBM utilized novel study designs (3). These included rapid dose escalation and loading of FBM after withdrawal from other AEDs in patients undergoing presurgical evaluations and trials allowing FBM mo...

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Felbamate for partial seizures

Cited by 165 publications

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New Add-on Therapy for Partial-onset Epilepsy

New Add-on Therapy for Partial-onset Epilepsy

Advances in pharmacotherapy: recent developments in the treatment of epilepsy

Felbamate

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