Perampanel, an antiepileptic drug, is an AMPA glutamate receptor antagonist. As of 8 March 2021, it is authorised in the European Union, in combination with other antiepileptics, for use in: children from 4 years of age and adults with partial-onset seizures, and children from 7 years of age and adults with generalised seizures. In these settings, in adults and adolescents, perampanel is an option after failure of other, better-established antiepileptic drugs (1-3). In 2020, in the European Union, the adverse effect "Stevens-Johnson syndrome", a serious bullous skin rash, was added to the summary of product characteristics (SPC) and the package leaflet for perampanel. This followed a documented case of Stevens-Johnson syndrome, occurring after 9 days of treatment, which had a favourable outcome after perampanel discontinuation. This adverse effect comes in addition to "DRESS syndrome" (a combination of severe drug-related skin rash, multiorgan involvement and eosinophilia) which had already been included in the SPC and the package leaflet since 2018. The SPC specifies that onset of Stevens-Johnson syndrome or DRESS during treatment with perampanel necessitates immediate and permanent discontinuation of the drug (3). Since 2020, the SPC and the package leaflet also mention "hepatotoxicity (mainly hepatic enzyme increased)" with perampanel, and recommend "monitoring of liver function" (without further details). This modification is based on 12 cases of severe hepatotoxicity (no details provided) which had a favourable outcome after drug discontinuation, and 1 severe case with recurrence of symptoms after reintroduction of perampanel (3).
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