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News / April 30, 2009

IMB eases fears over products containing salicylate

by Guy Hiscott

The Irish Medicines Board (IMB) has stated that it is satisfied that the risk-benefit for the use of salicylate-containing products in children is positive when applied according to their approved conditions of use, despite the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) decision to restrict the use of salicylate-containing products for oral use in children under the age of 16.

The IMB’s decision has 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. The IMB will continue to monitor these products closely on the Irish market.

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.

The IMB states that at present there are two relevant products containing this active ingredient licensed in Ireland, Bonjela Oromucosal Gel and Teejel Gel. These products have been licensed for use in children since 1983 for the treatment of infant teething. The IMB states that the risk associated with their short-term use is extremely low and to date 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 IMB emphasises that before any medicine is administered to a child, parents are advised to read the product information (labelling/patient information leaflet) carefully and consult with their doctor or pharmacist as appropriate.