Vigabatrin: A comprehensive review of drug properties including clinical updates following recent FDA approval

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33 Citations (Scopus)

Abstract

Background: Vigabatrin (Sabril®) was approved in the USA in mid-2009 for the adjunctive treatment of refractory complex partial seizures and as treatment of infantile spasms. Vigabatrin's more than 30-year history of research and development is condensed into a clinically relevant review pertaining to this 2009 approval. Methods/discussion: A review of the scientific literature was conducted with special focus given to the drug molecule, its mechanism of action, its effects on living systems (e.g., pharmacokinetic, pharmacologic and toxicologic), and its anticipated role among antiepileptic drugs in the USA. Conclusions: The recent approval of vigabatrin makes a significant addition to antiepileptic drug options. The FDA implemented a Risk Evaluation and Mitigation Strategy to control for the possibility of severe adverse drug events.

Original languageEnglish
Pages (from-to)3077-3089
Number of pages13
JournalExpert Opinion on Pharmacotherapy
Volume10
Issue number18
DOIs
StatePublished - Dec 2009

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Vigabatrin
Pharmaceutical Preparations
Anticonvulsants
Infantile Spasms
Drug-Related Side Effects and Adverse Reactions
Seizures
Pharmacokinetics
Research

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)
  • Pharmacology

Cite this

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title = "Vigabatrin: A comprehensive review of drug properties including clinical updates following recent FDA approval",
abstract = "Background: Vigabatrin (Sabril{\circledR}) was approved in the USA in mid-2009 for the adjunctive treatment of refractory complex partial seizures and as treatment of infantile spasms. Vigabatrin's more than 30-year history of research and development is condensed into a clinically relevant review pertaining to this 2009 approval. Methods/discussion: A review of the scientific literature was conducted with special focus given to the drug molecule, its mechanism of action, its effects on living systems (e.g., pharmacokinetic, pharmacologic and toxicologic), and its anticipated role among antiepileptic drugs in the USA. Conclusions: The recent approval of vigabatrin makes a significant addition to antiepileptic drug options. The FDA implemented a Risk Evaluation and Mitigation Strategy to control for the possibility of severe adverse drug events.",
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AU - Tolman, Justin A.

AU - Faulkner, Michele A.

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N2 - Background: Vigabatrin (Sabril®) was approved in the USA in mid-2009 for the adjunctive treatment of refractory complex partial seizures and as treatment of infantile spasms. Vigabatrin's more than 30-year history of research and development is condensed into a clinically relevant review pertaining to this 2009 approval. Methods/discussion: A review of the scientific literature was conducted with special focus given to the drug molecule, its mechanism of action, its effects on living systems (e.g., pharmacokinetic, pharmacologic and toxicologic), and its anticipated role among antiepileptic drugs in the USA. Conclusions: The recent approval of vigabatrin makes a significant addition to antiepileptic drug options. The FDA implemented a Risk Evaluation and Mitigation Strategy to control for the possibility of severe adverse drug events.

AB - Background: Vigabatrin (Sabril®) was approved in the USA in mid-2009 for the adjunctive treatment of refractory complex partial seizures and as treatment of infantile spasms. Vigabatrin's more than 30-year history of research and development is condensed into a clinically relevant review pertaining to this 2009 approval. Methods/discussion: A review of the scientific literature was conducted with special focus given to the drug molecule, its mechanism of action, its effects on living systems (e.g., pharmacokinetic, pharmacologic and toxicologic), and its anticipated role among antiepileptic drugs in the USA. Conclusions: The recent approval of vigabatrin makes a significant addition to antiepileptic drug options. The FDA implemented a Risk Evaluation and Mitigation Strategy to control for the possibility of severe adverse drug events.

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