THE IRISH Medicines Board (IMB) has said it is safe for parents here to continue using Bonjela despite a warning from its counterpart in the UK that certain types of the product should not be given to children under 16 years.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK issued the alert about Bonjela or Bonjela Cool mint gel yesterday following a review which noted there was a theoretical risk the products could increase the possibility of a child developing Reye’s syndrome – a rare but serious condition. It had also received reports of adverse reactions to the products in children.
However, parents in the Republic can continue to use the products to soothe the gums of teething babies. The IMB said it had done its own review and is satisfied that “the risk-benefit for the use of salicylate-containing products in children is positive when used according to their approved conditions of use”.
“The IMB’s advice to parents and carers is that oral gels containing choline salicylate should be applied very sparingly and only at the frequency indicated in the product information. These products should only be used when clearly necessary and are intended for short-term use only,” it noted.
Bonjela Oromucosal Gel and Teejel Gel, licensed in Ireland for use in children since 1983, contain these active ingredients and the IMB says the risk associated with their short-term use is extremely low and to date it has received no reports of adverse reactions in children with these products. “The risk of toxicity is associated with incorrect use or over-dosing”.
The products contain salicylate salts which have the same effect on the body as aspirin, which is already not recommended in the UK for those under the age of 16.
The IMB said the MHRA decision had been taken following a risk/benefit review which was conducted following publication of a case report in June 2008 of a suspected but unconfirmed case of Reye’s syndrome associated with the use of an oral gel containing choline salicylate in a 20 month old child.
“The review concluded that the symptoms reported in the case report were not consistent with Reye’s syndrome and were more likely to reflect salicylate toxicity due to incorrect use of the gel,” it added.
As of April 16th 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.