MHRA warns against Bonjela for use in under-16s

April 25, 2009 by admin 

Bonjela and Bonjela Cool Mint Gel should not be used by people under 16 years of age, according to a new recommendation from the MHRA issued on 21 April. Other Bonjela products are not affected.

The new advice is that “topical oral pain relief products containing salicylate salts should be contraindicated in children and young people under the age of 16 years”. New packaging and patient information is expected to be available in May.

The MHRA says that this is a precautionary measure because of the theoretical risk of Reye’s syndrome, and brings these products into line with others containing oral salicylates. MHRA advice is that those under 16 should not take aspirin unless recommended by a doctor.

By April 2009, the MHRA had received a total of three suspected serious Adverse Drug Reactions (ADR) reports associated with the use of topical oral gels containing choline salicylate in children: Reye’s syndrome was suspected in all three but confirmed in none.

One other product is also affected: Pyralvex is a pharmacy-only product, an oral paint containing salicylic acid for denture and mouth ulcer pain for people over 12 years old; the new advice is it should only be used in those over 16.

The MHRA suggests alternatives to these products. For infant teething pain, it says gentle pressure with something cool may be helpful; a number of products containing a local anaesthetic/mild antiseptic that do not contain a salicylate can be used for teething pain or mouth ulcers; salt water mouthwashes are recommended for pain associated with orthodontic devices; and paracetamol is suggested for discomfort linked with tooth movement.

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