Updated 8:08pm 27 April 2012

Watchdog tells parents not to give children Bonjela

CHILDREN under 16 should not be given Bonjela or Bonjela Cool mint gel, a health watchdog said last night.

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 yesterday’s 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.

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 very serious condition.

“There are a number of options and alternative treatments for pain associated with teething and mouth ulcers.”

As of April 16 this year, three suspected serious adverse drug reactions (ADR) 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.

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.

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