Other safety alerts
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| European Union: New safety information for healthcare professionals: risk of medication errors due to change of dosing syringe for Keppra and Levetiracetam UCB oral solution |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) discussed a direct healthcare professional communication (DHPC) regarding a change to the dosing syringe included in the product packaging of Keppra and Levetiracetam UCB 100 mg/ml oral solution intended for use in children aged 6 months to 4 years (150 ml bottle). The 3 ml dosing syringe is being replaced with a 5 ml dosing syringe. The DHPC will inform healthcare professionals of the potential risk of medication errors due to the change in the volume of the dosing syringe.
Keppra and Levetiracetam UCB are medicines used to treat epilepsy, on their own or as an add-on to another anti-epileptic medicine.
When prescribing and dispensing levetiracetam (Keppra and Levetiracetam UCB) oral solution with the new 5 ml syringe, healthcare professionals should inform caregivers about the change in the volume of the dosing syringe. Caregivers should be informed that while the new 5 ml syringe is graduated every 0.1 ml, it has additional graduations of 0.25 ml compared to the 3 ml syringe. Caregivers should be counselled on the correct dose and how to measure it with the 5 ml syringe. Caregivers should be advised to read the instructions in the package information leaflet on how to recognise signs and symptoms of a levetiracetam overdose and what to do in this situation.
The DHPC for Keppra and Levetiracetam UCB will be forwarded to EMA’s human medicines committee (CHMP). When adopted, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holders, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in EU Member States.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-30-september-3-october-2024
In Hong Kong, there are 5 registered pharmaceutical products containing levetiracetam in oral solution, including Keppra Oral Solution 100mg/ml (HK-54926) registered by Glaxosmithkline Limited. All products are prescription-only medicines. Levetiracetam UCB is not a registered pharmaceutical product in Hong Kong. So far, the Department of Health (DH) has received 7 cases of adverse drug reaction with regard to levetiramcetam, but these cases were not related to medication errors. Healthcare providers and patients are advised to follow the instructions in package insert regarding the administration with oral syringe.
Ends/ Saturday, Oct 5, 2024
Issued at HKT 12:00
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