Evaluating the safety and efficacy of felbamate in the context of a black box warning: A single center experience
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. This single center analysis retrospe...
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| Published in | Epilepsy & behavior Vol. 56; pp. 50 - 53 |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
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United States
Elsevier Inc
01.03.2016
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1525-5050 1525-5069 1525-5069 |
| DOI | 10.1016/j.yebeh.2016.01.006 |
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| Abstract | 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.
This single center analysis retrospectively evaluated the safety and efficacy of felbamate in a cohort of children, adolescents, and adults with epilepsy.
A chart review identified 103 patients taking felbamate. The range of felbamate dose was 300–4500mg (mean: 1800±900mg). The duration of therapy ranged from 1month to 20years (mean duration: 35±45months). 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.
These findings suggest that felbamate is safe, well tolerated, and effective in treatment of various types of epilepsy syndromes.
•Felbamate (FBM) is used to treat partial seizures and Lennox–Gastaut syndrome.•Black box warning was added because of fatal cases of aplastic anemia and liver failure.•We retrospectively analyzed FBM's safety and efficacy in 103 patients with epilepsy.•FBM was reasonably safe and effective to treat epilepsy. |
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| AbstractList | 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.
This single center analysis retrospectively evaluated the safety and efficacy of felbamate in a cohort of children, adolescents, and adults with epilepsy.
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.
These findings suggest that felbamate is safe, well tolerated, and effective in treatment of various types of epilepsy syndromes. 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.INTRODUCTIONFelbamate 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.This single center analysis retrospectively evaluated the safety and efficacy of felbamate in a cohort of children, adolescents, and adults with epilepsy.METHODSThis single center analysis retrospectively evaluated the safety and efficacy of felbamate in a cohort of children, adolescents, and adults with epilepsy.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.RESULTSA 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.These findings suggest that felbamate is safe, well tolerated, and effective in treatment of various types of epilepsy syndromes.CONCLUSIONSThese findings suggest that felbamate is safe, well tolerated, and effective in treatment of various types of epilepsy syndromes. 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. This single center analysis retrospectively evaluated the safety and efficacy of felbamate in a cohort of children, adolescents, and adults with epilepsy. A chart review identified 103 patients taking felbamate. The range of felbamate dose was 300–4500mg (mean: 1800±900mg). The duration of therapy ranged from 1month to 20years (mean duration: 35±45months). 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. These findings suggest that felbamate is safe, well tolerated, and effective in treatment of various types of epilepsy syndromes. •Felbamate (FBM) is used to treat partial seizures and Lennox–Gastaut syndrome.•Black box warning was added because of fatal cases of aplastic anemia and liver failure.•We retrospectively analyzed FBM's safety and efficacy in 103 patients with epilepsy.•FBM was reasonably safe and effective to treat epilepsy. Introduction: 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 plus or minus 900 mg). The duration of therapy ranged from 1 month to 20 years (mean duration: 35 plus or minus 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 greater than or equal to 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. Abstract Introduction 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. |
| Author | Devinsky, Orrin Friedman, Daniel Singh, Kanwaljit Shah, Yash D. Kothare, Sanjeev V. |
| Author_xml | – sequence: 1 givenname: Yash D. surname: Shah fullname: Shah, Yash D. organization: Department of Neurology, NYU Langone Medical Center, USA – sequence: 2 givenname: Kanwaljit surname: Singh fullname: Singh, Kanwaljit organization: Division of Pediatric Neurology, University of Massachusetts Medical School, USA – sequence: 3 givenname: Daniel surname: Friedman fullname: Friedman, Daniel organization: Department of Neurology, NYU Langone Medical Center, USA – sequence: 4 givenname: Orrin surname: Devinsky fullname: Devinsky, Orrin organization: Department of Neurology, NYU Langone Medical Center, USA – sequence: 5 givenname: Sanjeev V. surname: Kothare fullname: Kothare, Sanjeev V. email: sanjeev.kothare@nyumc.org organization: Department of Neurology, NYU Langone Medical Center, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26828692$$D View this record in MEDLINE/PubMed |
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| Snippet | Felbamate was approved in 1993 to treat partial seizures with and without secondary generalization in adults and in Lennox–Gastaut Syndrome in children. Its... Abstract Introduction Felbamate was approved in 1993 to treat partial seizures with and without secondary generalization in adults and in Lennox–Gastaut... Felbamate was approved in 1993 to treat partial seizures with and without secondary generalization in adults and in Lennox-Gastaut Syndrome in children. Its... Introduction: Felbamate was approved in 1993 to treat partial seizures with and without secondary generalization in adults and in Lennox-Gastaut Syndrome in... |
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| SubjectTerms | Adolescent Adult Adverse events Age of Onset Anemia, Aplastic - chemically induced Anticonvulsants - adverse effects Anticonvulsants - therapeutic use Aplastic anemia Child Cohort Studies Drug Labeling Epilepsy - drug therapy Felbamate Female Hepatic Humans Male Middle Aged Neurology Phenylcarbamates - adverse effects Phenylcarbamates - therapeutic use Propylene Glycols - adverse effects Propylene Glycols - therapeutic use Retrospective Studies Safety Seizures - drug therapy Treatment Outcome Young Adult |
| Title | Evaluating the safety and efficacy of felbamate in the context of a black box warning: A single center experience |
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