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Epilepsy drug Kaneuron°: hazardous packaging

Because of medication errors, the dosing syringe of the drinkable phenobarbital solution has been replaced. But the packaging is still hazardous: two dosing devices are presented side by side and the bottle has no child-proof cap.

In France, a drinkable phenobarbital solution is authorised as a treatment for adults and children for partial and generalised epilepsy. The use of phenobarbital is limited because of sedation and behavioural disorders, especially in children, but sometimes it is a useful option.

The packaging of Kaneuron° contains two dosing devices: a dropper for smaller doses and an oral syringe for higher doses. As a result of drug errors resulting in overdoses, particularly in infants, the dosing syringe has been modified: it is graduated by number of drops only instead of a dual graduation by number of drops and by millilitres, which gave rise to confusion.

This change is indicated on the box. But this improvement in the packaging of Kaneuron° does not go far enough: there is no child-proof cap on the bottle, carrying the risk of large quantities being accidentally ingested by children, particularly since the solution has a pleasant smell. The risks associated with massive ingestion are potentially severe, given that each 30 ml bottle contains 1.62 g of phenobarbital, whereas a dose of 20 mg/kg is toxic in children. The bottle also contains a high dose of alcohol.

The packaging of the drinkable solution of phenobarbital, Kaneuron°, remains hazardous. When using Kaneuron°, it is advisable to remove the dosing device that will not be used, to ensure that the instructions for using the dosing device have been clearly understood, and to keep the bottle out of children’s reach.

©Prescrire 1 April 2015

"Kaneuron°. An oral solution of phenobarbital with dangerous packaging" Prescrire Int 2015; 24 (159): 95. (Pdf, subscribers only).

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Drug packaging
and patient safety
(Advancing healthcare