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STEER CLEAR OF BONJELA

Recent advice on the use of Bonjela for children aged under 16 is the latest in a number of releases by the Medicines and Healthcare Products Regulatory Agency (MHRA) so far this year relating to children’s medicines.

This is a precautionary measure only and there are no new safety concerns


The drug safety agency issued a ‘precautionary alert’ about Bonjela and Bonjela cool mint as the gel contains salicylate salts. The Times reports that these have the same effect on the body as aspirin, which is not recommended for children under the age of 16.

Says the MHRA: “This is a precautionary measure only and there are no new safety concerns. The advice is being introduced due to a theoretical risk these products could increase the possibility of a child developing Reye’s syndrome – a rare but serious condition.” Reye’s syndrome is a very rare condition that causes liver and brain damage. The exact cause of the condition is unknown but previous viral infection, such as flu or chickenpox and exposure to aspirin may contribute to developing the condition.

There have been no confirmed cases of Reye’s syndrome associated with the gels although the MHRA has received three suspected Adverse Drug Reactions (ADR) reports in association with the use of the gels but none have confirmed Reye’s syndrome.

The MHRA is keen to point out that parents should not be worried if they have already given their child the gel. MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said: “Any risk from these oral gel products is theoretical. We are not aware of any confirmed cases, but when there are alternatives available, any risk is not worth taking. The new advice is to stop using these products in children and young people under 16, and to use alternative treatments.”

A number of options are available to treat pain for teething and mouth ulcers. Dental gels are available that contain a local anaesthetic or mild antiseptic without the salicylate salts.

Useful links: Teething treatment – cks.library.nhs.uk/patient_ information_leaflet/teething