Literature DB >> 26828692

Evaluating the safety and efficacy of felbamate in the context of a black box warning: A single center experience.

Yash D Shah1, Kanwaljit Singh2, Daniel Friedman1, Orrin Devinsky1, Sanjeev V Kothare3.   

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.
Copyright © 2016 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Adverse events; Aplastic anemia; Felbamate; Hepatic; Safety

Mesh:

Substances:

Year:  2016        PMID: 26828692     DOI: 10.1016/j.yebeh.2016.01.006

Source DB:  PubMed          Journal:  Epilepsy Behav        ISSN: 1525-5050            Impact factor:   2.937


  5 in total

1.  Post-Marketing Regulation of Medicines Withdrawn from the Market Because of Drug-Attributed Deaths: An Analysis of Justification.

Authors:  Igho J Onakpoya; Carl J Heneghan; Jeffrey K Aronson
Journal:  Drug Saf       Date:  2017-05       Impact factor: 5.606

2.  Predominant and novel de novo variants in 29 individuals with ALG13 deficiency: Clinical description, biomarker status, biochemical analysis, and treatment suggestions.

Authors:  Bobby G Ng; Erik A Eklund; Sergey A Shiryaev; Yin Y Dong; Mary-Alice Abbott; Carla Asteggiano; Michael J Bamshad; Eileen Barr; Jonathan A Bernstein; Shabeed Chelakkadan; John Christodoulou; Wendy K Chung; Michael A Ciliberto; Janice Cousin; Fiona Gardiner; Suman Ghosh; William D Graf; Stephanie Grunewald; Katherine Hammond; Natalie S Hauser; George E Hoganson; Kimberly M Houck; Jennefer N Kohler; Eva Morava; Austin A Larson; Pengfei Liu; Sujana Madathil; Colleen McCormack; Naomi J L Meeks; Rebecca Miller; Kristin G Monaghan; Deborah A Nickerson; Timothy Blake Palculict; Gabriela Magali Papazoglu; Beth A Pletcher; Ingrid E Scheffer; Andrea Beatriz Schenone; Rhonda E Schnur; Yue Si; Leah J Rowe; Alvaro H Serrano Russi; Rossana Sanchez Russo; Farouq Thabet; Allysa Tuite; María Mercedes Villanueva; Raymond Y Wang; Richard I Webster; Dorcas Wilson; Alice Zalan; Lynne A Wolfe; Jill A Rosenfeld; Lindsay Rhodes; Hudson H Freeze
Journal:  J Inherit Metab Dis       Date:  2020-08-05       Impact factor: 4.982

Review 3.  Elucidating the Potential Side Effects of Current Anti-Seizure Drugs for Epilepsy.

Authors:  Enes Akyüz; Betül Köklü; Cansu Ozenen; Alina Arulsamy; Mohd Farooq Shaikh
Journal:  Curr Neuropharmacol       Date:  2021       Impact factor: 7.708

Review 4.  Expanding the Treatment Landscape for Lennox-Gastaut Syndrome: Current and Future Strategies.

Authors:  Adam Strzelczyk; Susanne Schubert-Bast
Journal:  CNS Drugs       Date:  2021-01-21       Impact factor: 5.749

5.  Felbamate for pediatric epilepsy-should we keep on using it as the last resort?

Authors:  Shira Rabinowicz; Tal Schreiber; Gali Heimer; Omer Bar-Yosef; Andreea Nissenkorn; Zohar-Dayan E; Leo Arkush; Nasrin Hamed; Bruria Ben-Zeev; Michal Tzadok
Journal:  Front Neurol       Date:  2022-09-20       Impact factor: 4.086

  5 in total

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