MHRA advises against use of oral painkiller gels in under 16s

22 April 2009

The UK's drug safety regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is issuing precautionary advice for topical  oral pain relief gels containing salicylate salts.

The main products affected are Bonjela and Bonjela Cool Mint Gel,  marketed by German drugmaker Bayer. The new advice recommends these  products are not used in those under 16 years of age, as salicylates  have the same effect as aspirin, which is already contraindicated in  this age group.

The MHRA stressed 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.

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