UK: Ulcer Gels Like Bonjela Should Not Be Used In Children Below 16 Years Old
It is theorised that a choline salicylate gel may cause Reye's syndrome.
By May Vin Ang — 23 Aug 2021, 03:28 PM — Updated about 3 years ago
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Editor's note: The story has been updated with a statement from Reckitt Benckiser Malaysia.
Children under the age of 16 have been advised against using pain relief mouth gels that contain salicylates, such as Bonjela
According to a recent Facebook post by Public Health Malaysia, parents should take note of this 2009 warning by the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
For context, Bonjela is a topical gel commonly used to relieve pain and reduce inflammation for the treatment of mouth ulcers, brace sores, and denture irritation.
While there are other brands of oral ulcer gels in Malaysia, Bonjela was quoted as an example not to be used for children due to an ingredient – a pain relief agent called choline salicylate.
Choline salicylate is a salicylate salt similar to aspirin, a medication that is contraindicated for children under 16 years old
While safe for relieving pain in adults, aspirin can cause Reye's syndrome in children and teenagers – a rare disorder that causes serious liver and brain damage.
If not treated promptly, it may lead to permanent brain injury or death.
The MHRA warned that there was a theoretical risk that topical ulcer gels with salicylate salts could also lead to children developing the life-threatening condition.
The regulator had received a report of a child being hospitalised with suspected adverse drug reactions after excessively using Bonjela
While they could not prove the child had Reye's syndrome, as it was more likely salicylate toxicity, MHRA released the warning anyway to prevent future occurrences.
"Irrespective of the diagnosis, it is clear that a choline salicylate gel, if applied chronically and excessively, can result in systemic levels of salicylate... If used in excess, could increase the risk of Reye's syndrome," it said.
Bonjela manufacturer and worldwide distributer Reckitt Benckiser has since clearly labelled Bonjela as a mouth gel brand for adults in the UK
According to the Bonjela UK website, the regular Bonjela box now shows an 'Adult 16+' warning on its packaging and they have since released a formulation specially for children called Bonjela Junior.
Meanwhile, as an alternative to topical oral salicylate gels, the MHRA has advised that children under 16 can also:
- Use a dental gel that contains another type of local anaesthetic or mild antiseptic.
- Use a salt water mouthwash for soreness and pain related to orthodontic devices.
- Take a paracetamol-based painkiller for discomfort arising from tooth movement.
- Apply gentle pressure with something cool, such as a chilled teething ring, to relieve infant teething pain.
Speaking to SAYS, Reckitt Benckiser Malaysia has assured that Bonjela is safe to be used in children above four months old
In a statement, they said the age restriction and labelling was only requested by the MHRA in the UK.
"Bonjela is a global brand sold across 23 countries. The labelling regulation varies by market as according to each market local regulation," they said.
They assured that like the New Zealand Medicine and Medical Devices Safety Authority (Medsafe) and the Irish Health Products Regulatory Authority (HPRA), Malaysia has reviewed data and confirmed that Bonjela is safe for use in children above four months old when it is used as per the recommended dose as stated on their packaging.
"Adding on, our safety data is constantly being reviewed and no evidence was found to support applying this age restriction globally," they said.
"We review and update the latest science and expert knowledge for our ingredients used and constantly update our safety profiles to ensure the safety of our products for our consumers."
They also ensured that all their products sold locally comply with local regulations and are approved by the National Pharmaceutical Regulatory Agency (NPRA).
However, as with all medicines, they do advise consumers to consult healthcare professionals before use of their products, and to always use them according to recommended dosing and directions.
