LONDON (Reuters Life!) - Children under 16 should not be given mouth pain relief gels Bonjela and Bonjela Cool that contain an aspirin-type chemical, a British health regulator said on Thursday.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued the warning over treatments containing salicylate salts, which have the same effect on the body as aspirin.
Aspirin is already not recommended for those under 16.
The MHRA said there was a theoretical risk that products with the salts could lead to children developing Reye’s Syndrome, a rare condition that causes serious liver and brain damage.
There have been no confirmed cases of Bonjela or Bonjela Cool Mint Gel causing Reye’s, it said.
However, the regulator has received reports of three children hospitalized with suspected serious adverse drug reaction after using oral gels such as Bonjela.
In all cases Reye’s Syndrome was suspected but not confirmed.
There have also been four reports of vomiting or diarrhea in children following the Bonjela use. In three of the cases the gel had been given for teething pain, and in all cases the children recovered completely.
Manufacturer Reckitt Benckiser said Bonjela and Bonjela Cool would now be clearly labeled as adult brands.
It said the warning did not apply to its Bonjela Teething Gel, which does not contain salicylate salts and remains safe for children from just two months old.
Reporting by Tim Castle; Editing by Steve Addison and Paul Casciato