Published: 2 November 2022
Committees
Reclassification of choline salicylate
Medsafe has moved to ensure parents buying Bonjela for oral pain relief in infants (children under 18 months) receive advice on safe usage by restricting sales of the over-the-counter medicine to pharmacies.
Bonjela, whose active ingredient is choline salicylate, will remain available for sale in supermarkets for use in older children and adults – where it is commonly used for treating mouth ulcers.
The decision to reclassify choline salicylate for infants under 18 months, as a pharmacy only medicine, from 1 May next year follows a recommendation from an expert committee concerned about the potential for unintentional over-treatment in infants.
The recommendation means that from 1 May 2023, Bonjela, which is the only product in New Zealand containing choline salicylate, will only be available from pharmacies when for use in infants under 18 months of age.
Medsafe Group Manager Chris James says this decision has been made following careful review of the risk that infants can become seriously ill following treatment with a larger than recommended dose of Bonjela for teething.
Mr James says Medsafe strongly recommends that people always follow the instructions for use for any medicine.
The change from 1 May will help ensure caregivers are able to get advice from their pharmacy when purchasing products such as Bonjela for teething in infants and also allow the opportunity for pharmacists to provide further health advice if needed.
Mr James says like all medicines approved for use in New Zealand, Bonjela is safe and effective – when used as directed.
Medsafe is confident that choline salicylate meets the appropriate standards for safety and effectiveness when the recommended dose is given.
Anyone with questions or concerns about the use of choline salicylate should speak to their doctor, prescriber or pharmacist, or call HealthLine on 0800 611 116.
All medicines can potentially cause adverse reactions. As for any medicine, Medsafe recommends consumers always follow the instructions on the packet or given by a healthcare professional to reduce the risk of experiencing a reaction.
We also ask that consumers and healthcare professionals inform the Centre for Adverse Reaction Monitoring (CARM) if they have experienced an adverse reaction. This helps CARM and Medsafe monitor the safety of medicines being used in New Zealand.
Background information
Choline salicylate is similar to aspirin and acts to reduce inflammation and pain.
It relieves mild to moderate pain and reduces fever, inflammation or swelling.
This medicine is also a main ingredient in teething gels to relieve pains associated with teeth breaking through the gums in infants.
It is also used in other products to treat arthritis, fever and other conditions in both children and adults.
