Royal Pharmaceutical Society Of Great Britain Responds To Guidance On Oral Salicylate Gels In Under-16s

Main Category: Pediatrics / Children's Health
Also Included In: Pain / Anesthetics;  Dentistry;  Regulatory Affairs / Drug Approvals
Article Date: 24 Apr 2009 - 0:00 PDT

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Parents and caregivers concerned about the use of Bonjela and Bonjela Cool Mint Gel on children under the age of 16 should consult their pharmacist, the Royal Pharmaceutical Society of Great Britain (RPSGB) recommends.

The advice comes after guidance issued by the Medicines and Healthcare Regulatory products Agency (MHRA) advised that products containing salicylate salts, like Bonjela and Bonjela Cool Mint Gel, should not be used for children under the age of 16.

The RPSGB's Director of Policy, David Pruce said the guidance from the MHRA was based on the slim and theoretical risk that products containing salicylate salts could increase the possibility of a child developing the rare condition of Reye's syndrome.

"Salicylate salt-containing products have effects similar to aspirin on children under the age of 16. There is a very remote risk for young children using this product and it is always best to err on the side of caution.

"If people are in doubt about using products containing salicylate salts, or if they have questions about the products, they should consult their pharmacist for expert advice."

Bonjela and Bonjela Cool Mint Gel are often used on the gums of children who are teething as a form of pain-relief.

David Pruce said: "There are other products on the market which have the same soothing effect, but which do not contain salicylate salts and are therefore safe to use on children younger than 16."

Products able to be used for children under the age of 16 include:

- Bonjela Teething Gel
- Calgel
- Anbesol Teething Gel
- Anbesol Liquid
- Dentinox

The new packaging for Bonjela and Bonjela Cool Mint Gel is expected to be available week commencing 18 May. In the meantime Bonjela and Bonjela Cool Mint Gel with the older labelling will continue to be available and can be supplied for use by adults and children over the age of 16 years. Pyralvex contains salicylic acid and is currently available for children over the age of 12 years. It is a pharmacy-only medicine. It is now recommended that this should not be used in young people under the age of 16 years.

For further information and guidance, please refer to the MHRA website at http://www.mhra.gov.uk

Source
Royal Pharmaceutical Society of GB

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