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Warning over Bonjela products.

Summary: Children under 16 should not be given the oral pain relief products Bonjela or Bonjela Cool mint gel, a health watchdog has said.

Children under 16 should not be given the oral pain relief products Bonjela or Bonjela Cool mint gel, a health watchdog has said.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert on oral pain relief gels which contain salicylate salts.

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.

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.

Bonjela Teething Gel for young children contains a different formula and is unaffected.

An MHRA statement 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."

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.

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.

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.

The statement 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."

The Government's Chief Dental Officer, Barry Cockcroft, said: "Following on from advice issued in 2002 that aspirin should not be given to children under 16 years old, the Medicines and Healthcare products Regulatory Agency have extended this advice to a sister product - salicylate salts. These are found in Bonjela, Bonjela Cool mint gel or Dinnefords Teejel Gel, which are used to treat teething, mouth ulcers and sores.

"This is a precautionary measure and people using these products, or who have used them in the past, should not be concerned."

Independent Television News Limited 2009. All rights reserved.

Independent Television News Limited 2009. All rights reserved.

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Publication:Independent Television News Limited (ITN)
Date:Apr 24, 2009
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