Medsafe’s decision was made following a review of the risk that infants could become seriously ill following treatment with a larger than recommended dose of Bonjela. (File image)
Medsafe is set to restrict over-the-counter sales of Bonjela to pharmacies due to the risk that infants can get seriously ill if given too much.
Why it matters
- Bonjela – the only product in New Zealand containing choline salicylate – relieves mouth ulcers, mouth pain, and is commonly used to soothe teething infants.
- Gels with choline salicylate gained attention in 2009 when the United Kingdom’s Commission on Human Medicines advised that people under the age of 16 should not use these types of products.
- Medsafe’s decision was made following a review of the risk that infants could become seriously ill following treatment with a larger than recommended dose of Bonjela.
* Baby’s Bonjela scare leads mum to call for warnings over mouth gels
* Teething products on sale in NZ despite warnings
* Covid-19: NZ’s Medsafe in touch with Europe after handful of vaccine-linked deaths among frailest patients
Bonjela will remain available for sale in supermarkets for use in older children and adults.
However, for infants under 18 months, choline salicylate will be reclassified as a pharmacy only medicine from May 1 next year, following a recommendation from an expert committee concerned about the potential for unintentional over-treatment in infants for teething.
Medsafe Group Manager Chris James said the labelling on Bonjela packaging will change to make it clear the product in the supermarket is not pain relief for babies who are teething.
The product in pharmacies will have labelling showing the product can be used on teething infants.
“The important difference is that parents or others buying Bonjela for teething are able to get advice from the pharmacist about use of the product and other options including when to get further medical advice,” James said.
Who said what
Te Whatu Ora Waitaha Canterbury specialist paediatric dentist, Arun Natarajansaid Bonjela was an “oversold” medication and pharmacies should be monitoring sales.
Natarajan said a lack of warning labels on the product meant parents could poison their children and not realise it.
He said the problem was symptoms of acute salicylate poisoning could be minimal even with severe toxicity, and not evident until 6-12 hours after consumption.
“If parents don’t know how much to use, and there are no warning labels that it can cause salicylate poisoning, parents might not be aware it’s causing harm.”
Our children are losing the battle against tooth decay. (Video first published June 10, 2021)
There are other things parents can do to help a teething baby, and Bonjela was not the best option, Natarajan said.
Chilled teething rings, rattles, a cold flannel or paracetamol could be just as effective. A prescription medicine was available if those were not successful, he said.
“Bonjela, I am happy for them to use it, but they need to be aware of the risks, and warning signs.”
Bonjela said it had already introduced a product that did not contain choline salicylate to help soothe teething.
There are currently two Bonjela products circulating – one with and one without choline salicylate.
The new formulation has been listed as a medical device with Medsafe, and is available for infants aged over six months through supermarkets and pharmacies.
Bonjela also said it supported Medsafe’s decision.
“We agree that products containing choline salicylate should be made available in pharmacies where there is a pharmacist available to help emphasise to parents the importance of using these products as directed.”
In 2019, a baby was flown to Auckland’s Starship Hospital after her mother had given her too much Bonjela.
Jessica Vermunt said her daughter was “minutes from dying”.
At the hospital, she was sedated and put onto a breathing machine while the doctors did blood infusions and transfusions, Vermunt said.
The Ministry of Health did not have definitive data on how many Bonjela poisonings occurred each year, but believed it to be a very small number.
From 2002 to 2009, the New Zealand Poisons Centre received 279 calls relating to the use of these type of mouth gels in children.
From August 2016 to April 2019, the centre had received inquiries for 198 patients, aged from under one to six years old, concerning exposure to teething gel products.
Of those 198, 45 patients were referred for medical follow-up for various reasons. Other patients either required no treatment or care at home.