To combat accidental overdose, the European Medicines Agency (EMA) is recommending several safety measures when using the oral solution version of levetiracetam (Keppra, UCB, Inc) for treating epilepsy, according to a statement released today.
The main recommendation is that parents and caregivers of young patients should only use the dosing syringe that comes with the medication's age-appropriate and color-coded packaging.
"The different medicine's cartons and labels will be coloured differently and clearly indicate the volume of the bottle, the volume of the dosing syringe, and the age range of the child that the medicine should be used for," reports the EMA.
The new packaging will include:
blue cartons for children between the ages of 1 and 6 months, with a 150-mL bottle and 1-mL syringe;
green cartons for ages 6 to 48 months, with a 150-mL bottle and 3-mL syringe; and
yellow cartons for those aged 4 years and older, with a 300-mL bottle and a 10-mL syringe.
The agency reports that although the medication is indicated to treat both adults and children with epilepsy, the majority of accidental overdose cases with this oral solution have been in children. Most occurred because caregivers did not understand how to measure the dose properly. For example, they used a 10-mL syringe instead of the 1-mL version.
"Levetiracetam overdose often has no symptoms, but it may cause sleepiness, agitation, difficulty breathing and coma," they state.
In addition to the packaging changes, the included leaflet will be updated to provide clearer instructions on the right way to dose, based on body weight. It will also include the recommendation to throw away the syringe after the bottle has been emptied.
The EMA reports that accidental overdose with this medication are up nearly 10-fold, with most accidental overdoses occurring in patients between the ages of 6 months and 11 years. These cases were reviewed "in the context of a safety signal evaluation" by the Pharmacovigilance Risk Assessment Committee of the Committee for Medicinal Products for Human Use.
Clinicians and pharmacists are instructed to advise parents/caregivers on the best way to measure the correct dose for young patients and to bring up any questions or concerns they have.
Also, "doctors should always prescribe the dose in mg with ml equivalence based on the correct age of the patient," the EMA adds.