Children under 16 should not be given the ulcer treatments Bonjela or Bonjela Cool mint gel because of potential health risks, the medicines watchdog warns today.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a precautionary alert on pain relief gels for the mouth that contain salicylate salts. These have the same effect on the body as aspirin, which is not recommended for those under the age of 16.

Bonjela is among the pain relief gels that contain the salts, which have been linked to Reye’s syndrome, a rare but potentially fatal condition in children. It is thought that a previous viral infection, such as flu or chickenpox, and exposure to aspirin could cause Reye’s syndrome, a metabolic disorder that can cause serious liver and brain damage.

The MHRA said that Bonjela’s adult formulations — designed to relieve the pain and swelling caused by mouth ulcers and denture and brace sores — were not recommended for children, but that Bonjela Teething Gel was safe.

In a statement, the Agency added: “This is a precautionary measure only and there are no new safety concerns.

“The advice is being introduced due to a theoretical risk that these products could increase the possibility of a child developing Reye’s syndrome — a rare but serious condition,” the agency said. “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.”

As of April 16, three suspected serious adverse drug reaction reports were received by the MHRA in association with the use of oral gels containing choline salicylate.

All three cases were in children and all ended up in hospital. However, Reye’s syndrome was not confirmed in any child. The MHRA also received another four reports of vomiting or diarrhoea in children after the use of Bonjela, three of which related to the child being given the gel for teething pain. All made a full recovery.

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. “We are not aware of any confirmed cases but, when there are alternatives available, any risk is not worth taking. The new advice is to stop using these products in children and young people under 16, and to use alternative treatments.

“For infants with teething there is helpful advice in the Department of Health’s Birth to Five publication.” Reckitt Benckiser, the manufacturer of Bonjela, said that it had redesigned packaging to make it easier for consumers to choose the right gel in light of the new recommendations. 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.

The company added: “There have been no confirmed cases of Reye’s syndrome associated with Bonjela or Bonjela Cool, which remain safe and effective treatments for adults and children 16 years and over.

“The MHRA’s new advice on oral salicylate gels for use in under-16s does not affect Bonjela Teething Gel . . . has been specially formulated to provide targeted relief without the use of salicylates.”

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