Direct healthcare professional communication on the risk of medication errors associated with overdosing with medicinal products containing levetiracetam oral solution (Keppra 100 mg/ml oral solution)
03.01.2017
Medis Adria d.o.o., as the local representative of UCB Pharma SA, the marketing authorisation holder for Keppra 100 mg/ml oral solution (levetiracetam), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of the risk of medication errors associated with overdosing with medicinal products containing levetiracetam in form of oral solution.
Summary
- Cases of an up to 10-fold accidental overdose with Keppra (levetiracetam) oral solution have been reported. The majority of cases occurred in children aged between 6 months and 11 years. The use of an inadequate dosing device (e.g. confusion between a 1ml and a 10ml syringe, resulting in a 10-fold overdose) was identified as an important cause.
- Physicians should always prescribe the dose in mg with ml equivalence based on the correct age.
- Pharmacists should ensure that the appropriate presentation of levetiracetam oral solution is dispensed.
- With every prescription, physicians and pharmacists should advise the patient and/or caregiver on how to measure the prescribed dose.
- With every prescription, physicians and pharmacists should remind patients or caregivers to use only the syringe delivered with the medicine. Once the bottle is empty the syringe should be discarded and not kept.
Further information
Keppra 100 mg/ml oral solution is indicated as adjunctive treatment or monotherapy in the treatment of certain forms of epilepsy. The communication provides healthcare professionals with more detailed information on the risk of overdosing with levetiracetam oral solution due to the use of inappropriate syringe as well as on actions to be taken to reduce that risk.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
