Stop oral salicylate gels in under 16s

The Medicines and Healthcare products Regulatory Agency (MHRA) is issuing precautionary advice not to use topical oral pain relief gels containing salicylate salts.

The main products affected are Bonjela and Bonjela Cool Mint Gel. The new advice recommends these products are not used in those under 16-years-of-age. This is due to salicylate salts having the same effect on the body as aspirin which is already contraindicated in children and young people under 16-years-of-age.

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.

There are a number of options and alternative treatments for pain associated with teething and mouth ulcers. If parents, carers or young people are unsure how best to treat these problems they should ask a GP, health visitor, dentist or pharmacist for advice.

MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said this new advice brings these products into line with others containing aspirin.

“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. For infants with teething there is helpful advice in the Department of Health’s Birth to Five publication.”

Source: Medicines and Healthcare products Regulatory Agency, UK



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