Ulcer gel Bonjela should not be given to children under 16 years of age because of fears it could cause Reyes syndrome, a serious brain and liver condition. The Medicines and Healthcare Products Regulatory Agency (MHRA) issued the precautionary advice for topical oral pain relief gels containing salicylate salts, which include Bonjela and Bonjela Cool.

The new advice recommends that these products should only be used in patients who are 16 years of age and over. This is due to salicylate salts having the same effect on the body as asprin, which is already contraindicated in children and young people less than 16 years of age.

The MHRA's new advice does not affect Bonjela Teething Gel

Although there have been no reported cases of Reye's syndrome caused by the gel, the decision was made in order to bring it into line with other aspirin containing products for this age group. The MHRA's new advice does not affect Bonjela Teething Gel, which is safe to use in children from two months old.

Dr Aomesh Bhatt, Director of Regulatory and Medical Affairs North Europe for Bonjela owners Reckitt Benckiser Healthcare UK, said, 'We have been working very closely with the MHRA regarding this new precautionary advice for topical oral pain relief gels containing salicylate salts. Reckitt Benckiser has taken the decision to redesign the packaging for Bonjela and Bonjela Cool, both of which are now clearly labelled “Adults and children over 16”, and also redesigned Bonjela Teething Gel, to ensure the safe and appropriate use of the Bonjela range.'

Pyralvex, an oral paint for denture pain and the relief of mouth ulcer pain, is another product containing salicylic acid. It is a pharmacy-only medicine and is currently available for children over 12 years of age, but is now recommended not to be used in people under the age of 16. Gels, pastes and mouthwashes containing salicylate are regarded as safe for use in adults over 16 years old.

The recommendations for alternatives to treat pain associated with infant teething and mouth ulcers include gentle pressure with something cool such as a chilled teething ring for infant teething pain and dental gels containing a local anaesthetic/mild antiseptic to relieve pain associated with infant teething and mouth ulcers.