Society Responds to Guidance on Oral Salicylate Gels in Under-16s

LONDON - 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

Notes to Editors

1) The Royal Pharmaceutical Society of Great Britain is the professional and regulatory body for pharmacists in England, Scotland and Wales. It also regulates pharmacy technicians on a voluntary basis, which is expected to become statutory under anticipated legislation. The primary objectives of the Society are to lead, regulate, develop and represent the profession of pharmacy. The Society leads and supports the development of the profession within the context of the public benefit. This includes the advancement of science, practice, education and knowledge in pharmacy. In addition, it promotes the profession’s policies and views to a range of external stakeholders in a number of different forums. Following the publication in 2007 of the Government White Paper Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century, the Society is working towards the demerger of its regulatory and professional roles. This will see the establishment of a new General Pharmaceutical Council and a new professional body for pharmacy in 2010.

2) 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.

3) For further information and guidance, please refer to the MHRA website at www.mhra.gov.uk

Source: Royal Pharmaceutical Society of GB

MHRA’s Information Centre, +44(0)20-7084-2000; For media enquiries please contact the Royal Pharmaceutical Society of Great Britain’s Public Relations Unit on +44(0)20-7572-2336