Bonjela Restricted to Over 16-Year Olds in the UK

Image 1: Bonjela and Teejel.

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has issued new advice regarding the use of oral pain relief gels containing salicylate salts, such as Bonjela and Teejel. Since April 2009 MHRA no longer recommends the use of such products in children under 16 years of age.

This is in line with its policy on aspirin (acetylsalicylic acid) use, which has been associated with a rare but serious condition called Reye’s syndrome. In most Reye’s syndrome cases children had a previous viral infection, such as influenza (flu) or chickenpox in addition to being exposed to Aspirin. Reye's syndrome is characterized by acute encephalopathy and fatty liver.

A total of three suspected serious adverse drug reactions have been linked with the use of topical oral gels containing choline salicylate, however no cases of Reye’s syndrome were later confirmed and all children made a full recovery. The review concluded that the symptoms were more likely a result of salicylate toxicity due to incorrect use of the gel.

When used correctly the gel should be applied using a clean fingertip and used very sparingly (about half an inch of the gel) and only at the frequency indicated in the product information (no more than every three hours for Bonjela).

In response, the Irish Medicines Board (IMB) have issued a statement saying that following its own review, it 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 two products containing this active ingredient on sale in Ireland are Bonjela Oromucosal Gel and Teejel Gel. These products have been on the market since 1983 and to date the IMB have received no reports of adverse reactions in children with these products.

Possible alternatives to salicylate salts containing gels would include homeopathic products Teetha granules and/or gel and sugar-free paracetamol suspensions or paracetamol suppositories. Giving your baby something hard and/or cold to chew on, such as a (chilled) teething ring is also recommended, but make sure it’s not something that could pose a choking hazard.

L.G.