Bonjela and Bonjela Cool mint gel could be harmful to children under the age of 16, a health watchdog has announced.
The oral pain relief gels contains salicylate salts, which have the same effect on the body as aspirin – already not recommended for use by those under 16.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert due to concerns that young children could develop Reye's syndrome, a rare but serious condition that leads to serious liver and brain damage.
It is thought that a previous viral infection, such as flu or chickenpox, and exposure to aspirin could cause Reye's syndrome. No cases have yet been reported in connection with Bonjela.
The gel relieves pain and swelling caused by mouth ulcers, denture sores and brace sores. The two 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.
Since 16 April this year, three suspected serious adverse drug reaction 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.