Increased seizure frequency associated with felbamate withdrawal in adults. 1998

T E Welty, and M Privitera, and R Shukla
College of Pharmacy, University of Cincinnati Medical Center, Ohio 45267-0525, USA.

OBJECTIVE To characterize changes in seizure frequency following felbamate withdrawal. METHODS Nonrandomized, retrospective chart review of a case series. METHODS Epilepsy program specializing in adults with uncontrolled epilepsy. METHODS Forty-five ambulatory patients withdrawn from felbamate use. Patients were included if they had received felbamate for at least 1 month, were 18 years or older, had accurate seizure frequency documentation, had accurate documentation of all antiepileptic drugs, and received the same concomitant antiepileptic drugs before and after felbamate therapy, except for the possible addition of gabapentin. Patients were excluded if they had hematologic or hepatic toxic effects with felbamate, were unable to withdraw from felbamate treatment, had a progressive neurologic disorder, or participated in another drug trial. METHODS When information became available on aplastic anemia and hepatotoxicity associated with felbamate, all patients were advised to taper their felbamate dosage over approximately 2 weeks. They received written instructions for tapering felbamate and adjusting concomitant antiepileptic drugs and kept calendars to note the number of seizures. The charts of all patients who received felbamate were evaluated for adherence to inclusion and exclusion criteria. Statistical analysis was performed using a log-linear model for count data. METHODS Seizure frequency during the 6 months before initiating felbamate therapy served as the baseline. Changes in seizure frequency were evaluated by comparing the number of seizures in the month felbamate was tapered and the 3 months after felbamate discontinuation with the baseline frequency. Comparisons were made between patients who started gabapentin therapy and those who did not and between felbamate responders and nonresponders. RESULTS Felbamate withdrawal resulted in a significant (P=.02) increase in seizure frequency. Patients receiving gabapentin had a smaller increase in seizure frequency, but the difference was not statistically significant. There was no statistically significant difference in seizure frequency between felbamate responders and nonresponders. CONCLUSIONS Felbamate withdrawal caused a significant increase in seizure frequency over the subsequent 3 months. These findings are important for clinical trial design and clinical practice.

UI MeSH Term Description Entries
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011409 Propylene Glycols Derivatives of propylene glycol (1,2-propanediol). They are used as humectants and solvents in pharmaceutical preparations. Propanediols,Glycols, Propylene
D003509 Cyclohexanecarboxylic Acids Carboxylic acid derivatives of cyclohexane. Acids, Cyclohexanecarboxylic
D005680 gamma-Aminobutyric Acid The most common inhibitory neurotransmitter in the central nervous system. 4-Aminobutyric Acid,GABA,4-Aminobutanoic Acid,Aminalon,Aminalone,Gammalon,Lithium GABA,gamma-Aminobutyric Acid, Calcium Salt (2:1),gamma-Aminobutyric Acid, Hydrochloride,gamma-Aminobutyric Acid, Monolithium Salt,gamma-Aminobutyric Acid, Monosodium Salt,gamma-Aminobutyric Acid, Zinc Salt (2:1),4 Aminobutanoic Acid,4 Aminobutyric Acid,Acid, Hydrochloride gamma-Aminobutyric,GABA, Lithium,Hydrochloride gamma-Aminobutyric Acid,gamma Aminobutyric Acid,gamma Aminobutyric Acid, Hydrochloride,gamma Aminobutyric Acid, Monolithium Salt,gamma Aminobutyric Acid, Monosodium Salt
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000077206 Gabapentin A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME. 1-(Aminomethyl)cyclohexaneacetic Acid,Apo-Gabapentin,Convalis,Gabapentin Hexal,Gabapentin Stada,Gabapentin-Ratiopharm,Neurontin,Novo-Gabapentin,PMS-Gabapentin,Apo Gabapentin,ApoGabapentin,Gabapentin Ratiopharm,Novo Gabapentin,NovoGabapentin
D000078328 Felbamate A PEGylated phenylcarbamate derivative that acts as an antagonist of NMDA RECEPTORS. It is used as an anticonvulsant, primarily for the treatment of SEIZURES in severe refractory EPILEPSY. (3-Carbamoyloxy-2-phenyl-propyl) carbamate,2-Phenyl-1,3-propanediol dicarbamate,ADD-03055,Felbamyl,Felbatol,Taloxa,W-554,2 Phenyl 1,3 propanediol dicarbamate,ADD 03055,ADD03055,W 554,W554
D000085 Acetates Derivatives of ACETIC ACID. Included under this heading are a broad variety of acid forms, salts, esters, and amides that contain the carboxymethane structure. Acetate,Acetic Acid Esters,Acetic Acids,Acids, Acetic,Esters, Acetic Acid
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000588 Amines A group of compounds derived from ammonia by substituting organic radicals for the hydrogens. (From Grant & Hackh's Chemical Dictionary, 5th ed) Amine

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