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Introduction
Vigabatrin was developed as an antiepileptic in 1975. While shown to be effective in early clinical trials, the development of permanent vision impairment, including blindness, in some patients given vigabatrin quickly limited its role as a first-line therapy. Despite its potential utility in patients with seizures unresponsive to traditional antiepileptics, there has been reluctance to introduce a drug with this significant of an adverse profile in the United States. However, continued problems with the availability and cost of other treatments for infantile spasms and the completion of studies examining the risk for vision loss led the Food and Drug Administration (FDA) to alter its stance. Vigabatrin was approved on August 21, 2009, nearly 30 years after the new drug application was filed. It is indicated for the treatment of pediatric patients from 1 month to 2 years of age with infantile spasms for whom the potential benefits outweigh the risk of vision loss. It was also approved as an adjunctive therapy for adults with refractory complex partial seizures. This issue of Pediatric Pharmacotherapy will describe the clinical trials which supported the FDA approval and review the pharmacology of vigabatrin in children.
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