Vigabatrin is approved in Europe and Canada for the treatment of seizures.
The medication, whose brand name is Sabril, is used as adjunctive therapy for treating refractory complex partial seizures in adults and as monotherapy for infantile seizures in children. MedPage Today reports it’s up for consideration by the FDA’s advisory committee.
Problems arise from the drug’s chief side effect, namely, a deficit in peripheral field defects. The finding was dose dependent, and affected a quarter of adults and 15 percent of children.
Notably, the defects did not go away after the drug was stopped.
As there are currently no approved medications to treat infantile seizures, will the FDA allow the drug despite this significant side effect?
Or will the current climate surrounding dangerous medication-related complications keep vigabatrin on the sidelines?
