Fycompa Adverse Reactions

Summary of safety profile: In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 subjects have received Fycompa of whom 1,147 have been treated for 6 months and 703 for longer than 12 months.
In the controlled and uncontrolled trial in patients with primary generalised tonic-clonic seizures, 114 subjects have received Fycompa of whom 68 have been treated for 6 months and 36 for longer than 12 months.
Adverse reactions leading to discontinuation: In the controlled Phase 3 partial-onset seizures clinical trials, the rate of discontinuation as a result of an adverse reaction was 1.7%, 4.2% and 13.7% in patients randomised to receive Fycompa at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 1.4% in patients randomised to receive placebo. The adverse reactions most commonly (≥1% in the total Fycompa group and greater than placebo) leading to discontinuation were dizziness and somnolence.
In the controlled Phase 3 primary generalised tonic-clonic seizures clinical trial, the rate of discontinuation as a result of an adverse reaction was 4.9% in patients randomized to receive Fycompa 8 mg, and 1.2% in patients randomized to receive placebo. The adverse reaction most commonly leading to discontinuation (≥2% in the Fycompa group and greater than placebo) was dizziness.
Post-marketing use: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Fycompa treatment (see Precautions).
Tabulated list of adverse reactions: In the following table, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency. The following convention has been used for the classification of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
Within each frequency category, adverse reactions are presented in order of decreasing seriousness. (See Table 1.)

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Paediatric population: Based on the clinical trial database of 196 adolescents exposed to Fycompa from double-blind studies for partial onset seizures and primary generalized tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.