Child health alert over use of Bonjela

Published on Wednesday 22 April 2009 21:58

FOR years, it has offered quick relief to anyone suffering painful mouth ulcers or emerging wisdom teeth, or for teething children.

But now, a health watchdog has warned against giving children under the age of 16 Bonjela or Bonjela Cool mint gel.

The Medicines and Healthcare products Regulatory Agency (MHRA) today 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 the syndrome, which leads to liver and brain damage.

The Bonjela products affected are Bonjela and Bonjela Cool mint gel. Bonjela Teething Gel for young children has 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 mint gel.

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 that 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."

Three reports of suspected serious reactions have been received 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.

The MHRA also received 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.

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.

"Any risk from these oral gel products is theoretical. 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."

A statement from Reckitt Benckiser, which makes Bonjela, said it had redesigned packaging to make it easier to choose the right gel. Bonjela and Bonjela Cool will now be clearly labelled: "Adults and children over 16."

The government's chief dental officer, Barry Cockcroft, said: "This is a precautionary measure and people using these products, or who have used them in the past, should not be concerned."