Other safety alerts
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| European Union: EMA recommends measures to ensure safe use of Keppra oral solution |
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The European Medicines Agency (EMA) has recommended several measures to be put in place to ensure that the correct dosing syringe is used to measure Keppra oral solution, and thus avoid medication errors. Keppra (levetiracetam) is a medicine used to treat epilepsy in adults and children.
In children, the dose of Keppra depends on the child’s bodyweight and age, and the oral solution is the preferred formulation for use in children less than 6 years of age. The medicine is available as a 100 mg/ml solution in either a 150 or 300 ml size bottle, and it comes with a 1, 3 or 10 ml syringe.
To avoid medication errors and the risk of overdose, parents and carers are advised that only the syringe provided with the package should be used to measure the dose of Keppra. The package leaflet will also include clearer instructions for parents and carers in order to minimise the risk of using an incorrect dose. Parents and carers are advised always to discard the syringe once the medicine’s bottle is empty.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002622.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, Keppra Oral Solution 100mg/ml (HK-54926) is pharmaceutical product registered by GlaxoSmithKline Limited (GSK), and is prescription only medicine. The registered pack size is 300ml packed with a 10ml graduated syringe. So far, the Department of Health (DH) has received four adverse drug reaction cases related to levetiracetam. In view of the above EMA recommendation, DH will remain vigilant on this issue.
Ends/ Saturday, October 15, 2016
Issued at HKT 12:00
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