Pfizer has received reports of medication errors, some of which led to fatal overdose. A disproportionate number of fatal overdose cases have been reported when used off-label in patients under the age of 5 years. The medication errors involve administration of doses that are too high or intravenous infusion rates that are too rapid, some cases of which led to cardiac arrest or death.
This letter reiterates that Pro-Epanutin is not licensed for use in children under 5 years of age and should not be administered to this patient group. Its safety and efficacy have not been established in this age group. The SPC has been updated to clarify the dosing information and the need to closely monitor patients during IV administration, and to warn about medication errors. Paediatric and adult dosing aids have been developed to provide a summary for administration of Pro-Epanutin to patients with status epilepticus. The dosing aids will be enclosed with packs of Pro-Epanutin vials.