Ulcer gels warning for children
Children under 16 should not be given mouth pain relief gels Bonjela and Bonjela Cool mint gel, a health regulator said on Thursday.
The Medicines and Healthcare products Regulatory Agency issued the alert for the gels, warning they contain salicylate salts which have the same effect on the body as aspirin.
Aspirin is not recommended for children under the age of 16.
The agency said there were concerns that products with the salts could lead to children developing Reye's Syndrome, a rare condition which leads to serious liver and brain damage.
No cases of the syndrome have been reported in connection with Bonjela. But three children have been hospitalised in Britain after suffering serious reactions to mouth gels including Bonjela.
Another four cases were reported to the agency of children suffering vomiting or diarrhoea after using Bonjela. In three of the cases the children were given the gel for teething pain. All of the children made a full recovery.
"This is a precautionary measure only and there are no new safety concerns," the agency said in a statement.
"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."
"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."
Bonjela Teething Gel for young children contains a different formula and is unaffected.