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Warning on ulcer gels for children

23rd April 2009

A precautionary warning has been issued about mouth ulcer and teething treatment products for children under 16.


UK experts say that treatment containing salicylate salts should not be used by children because there is a theoretical risk that these products could cause Reye's syndrome.

The main products affected are Bonjela and Bonjela Cool Mint Gel.

But other products such as Bonjela Teething Gel, Calgel, Anbesol Teething Gel, Anbesol Liquid and Dentinox are not affected.

The Medicines and Healthcare products Regulatory Agency (MHRA) said the advice is only precautionary.

Salicylate salts have the same effect on the body as aspirin and the MHRA has received reports of three children being hospitalised after using oral gels containing choline salicylate.

However, Reye's syndrome, which is a rare disease that causes damage to many of the body's organs and can potentially be fatal, was not confirmed in any of the cases.

MHRA director of vigilance and risk management of medicines Dr June Raine said the new advice brings these products into line with others containing aspirin.

She 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 Royal Pharmaceutical Society of Great Britain stressed the risk was purely theoretical but said it was always best to err on the side of caution.

Reckitt Benckiser, which makes Bonjela, said it had redesigned packaging to make it easier for consumers to choose the right gel.


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Article Information

Title: Warning on ulcer gels for children
Author: Mark Nicholls
Article Id: 11104
Date Added: 23rd Apr 2009


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