Parents across Northern Ireland should not give children under 16 Bonjela or Bonjela Cool Mint Gel, a health watchdog has warned.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert on oral pain relief gels which contain salicylate salts.
The salts have the same effect on the body as aspirin, which is already not recommended for those under the age of 16.
There are concerns that young children could develop Reye’s syndrome, a rare but serious condition, although no cases have been reported in connection with Bonjela. It is thought a previous viral infection, such as flu or chickenpox, and exposure to aspirin could cause Reye’s syndrome, which leads to serious liver and brain damage.
The two Bonjela products affected by the announcement are Bonjela and Bonjela Cool Mint Gel. Bonjela Teething Gel for young children contains a different formula and is unaffected.
Bonjela is designed to relieve the pain and swelling caused by mouth ulcers, denture sores and brace sores. Bonjela Cool does the same thing but is formulated as a cool mint gel.
Raymond Anderson, president of the Pharmaceutical Society of Northern Ireland, the regulatory body for the pharmacy profession here, urged parents to speak to their pharmacist about alternative forms of oral pain relief available for children and young people.
“Some pain relief gels used to treat the symptoms of teething and mouth ulcers contain salicylate salts and these are no longer recommended for those under 16 years old. However not all oral pain relief gels do which is why advice should be sought from the pharmacist,” said the Portadown community pharmacist.
“I would like to reassure parents that there are alternative and effective forms of oral pain relief for children available from your local pharmacist.”
A statement from the MHRA said: “This is a precautionary measure only and there are no new safety concerns.
“The advice is being introduced due to a theoretical risk these products could increase the possibility of a child developing Reye’s syndrome — a rare but serious condition.
“There are a number of options and alternative treatments for pain associated with teething and mouth ulcers.
“If parents, carers or young people are unsure how best to treat these problems they should ask a GP, health visitor, dentist or pharmacist for advice.”
As of April 16 this year, three suspected serious adverse drug reactions reports were received by the MHRA in association with the use of oral gels containing choline salicylate, including Bonjela.
All three cases were in children and all ended up in hospital. However, Reye’s syndrome was not confirmed in any child. Dr June Raine, the MHRA’s director of vigilance and risk management of medicines, said the advice brought the products into line with others containing aspirin.
The MHRA also received another four reports of vomiting or diarrhoea in children following the use of Bonjela, three of which related to the child being given the gel for teething pain. All the children made a full recovery.
A statement from Reckitt Benckiser, which makes Bonjela, said it had redesigned packaging to make it easier for consumers to choose the right gel. “Bonjela and Bonjela Cool will now be clearly labelled Adults and Children over 16 and the packaging for Bonjela Teething Gel has also been changed,” it said.