Published: August 2009

Topical oral choline salicylate gels - safety in children

Prescriber Update 30(3): 17
August 2009

In New Zealand three topical products for oral use contain choline salicylate: Bonjela Teething Gel, Bonjela Mouth Ulcer Gel and Ora-sed gel.

Medsafe advises prescribers it is satisfied that the safety of these products in children is acceptable when used at recommended doses.

Medsafe’s advice follows a review of the recent decision by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to contraindicate the use of all topical oral choline salicylate gels in children under 16 years of age.

The MHRA decision was based on a case report published in the British Medical Journal in June 2008. The report described a suspected case of Reye’s syndrome in a 20 month old child following the use of Bonjela oral gel. Following its review the MHRA concluded that the symptoms described in this case could not be considered to be Reye’s syndrome and were more likely due to salicylate toxicity from overuse of the product. The MHRA subsequently contraindicated the use of these products in children under 16 years of age due to a theoretical risk of Reye's syndrome.

Medsafe reviewed data from the MHRA, the manufacturer of Bonjela, the Centre for Adverse Reactions Monitoring (CARM) and the New Zealand Poisons Centre. Medsafe’s review found no evidence linking Reye’s syndrome to the use of topical oral choline salicylate containing products.

Medsafe’s review has however highlighted that the recommended dose of these products is sometimes exceeded. The New Zealand Poisons Centre has advised Medsafe that 279 calls relating to the use of these products in children have been received since 2002.

Healthcare professionals are advised to remind parents and carers about the importance of reading the information provided with the medicine and adhering to the recommended dose. The approved dosing in New Zealand is to apply a small quantity of gel (ie tip of index fi nger) to the affected area no more than every three hours when required for the relief of pain and discomfort associated with infant teething. Parents and carers should also be reminded to keep all medicines out of sight and reach of children.