Important New Advice on the use of topical choline salicylates in children under 16
23rd April 2009There is new advice from the Medicines and Healthcare products Regulatory Agency (MHRA) that topical products containing choline salicylate - the main active ingredient in bonjela and bonjela cool mint gel - should no longer be used by children under the age of 16.
This advice is purely precautionary because of a theoretical risk. There are no new safety concerns.
bonjela and bonjela cool mint gel continue to be suitable and effective treatments for mouth ulcers in adults and adolescents 16 years or over. Parents whose children have previously used the products can be assured that there is very little risk of adverse reaction.
bonjela teething gel is totally unaffected by this new advice and remains suitable for teething babies over 2 months.
New packaging for the bonjela range will clearly highlight which products are suitable for adults and which for children. Anyone with concerns should speak to their pharmacist or GP.
Please click here for bonjela statement on this subject. Or for further information on the MHRA's new advice, click here. If you have any further questions, please contact our Medical Information Unit on 0500 455 456.
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bonjela has been used for over 40 years by consumers, selling over 62 million packs. bonjela and bonjela cool mint gel continues to be suitable and effective treatments for mouth ulcers in adults and adolescents over the age of 16, and bonjela teething gel remains a suitable treatment for teething in babies from 2 months.
Find the right bonjela product for your need
- Bonjela and bonjela cool mint gel remain suitable for over 16 year olds.
- Bonjela teething gel remains suitable for teething babies over 2 months.
IMPORTANT CHANGES TO THE BONJELA RANGE
bonjela has been used for over 40 years by consumers, selling over 62 million packs. bonjela and bonjela cool mint gel continues to be suitable and effective treatments for mouth ulcers in adults and adolescents over the age of 16, and bonjela teething gel remains a suitable treatment for teething in babies from 2 months.
bonjela and bonjela Cool Mint gel have new packaging and usage advice, following a recommendation by the Commission on Human Medicines. The Commission has advised that topical products containing Choline Salicylate - the main active ingredient in bonjela and bonjela Cool - should no longer be used by children under the age of 16.
This announcement is made following an investigation into links between topical Salicylates and Reye's Syndrome. The recommendation brings the regulation of Choline Salicylate in line with other Salicylates such as aspirin, which were similarly revised in 2002.
The changes to bonjela and bonjela Cool are precautionary measures. Parents whose children have previously used the products can be assured that there is very little risk of adverse reaction.
If there has been no reaction to date, you need not worry. However we advise you not to use these products on children under 16 years of age. bonjela teething gel can be used on children between two months and 16 years as it has a different formulation. As with any health issue, parents are advised to seek advice from a GP, health visitor or pharmacist.
bonjela Once is not subject to the new recommendation as it has a different formulation.
New Advice on the use of topical choline salicylates by children under 16
QUESTIONS & ANSWERS
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Can I keep using bonjela and bonjela cool if I am over the age of 16?
Yes, bonjela has been used for over 40 years by consumers selling over 62 million packs. bonjela and bonjela cool mint gel continues to be suitable and effective treatments for mouth ulcers in adults and adolescents over the age of 16, and bonjela teething gel remains a suitable treatment for teething in babies from 2 months. -
Can I still use bonjela teething gel on my teething baby?
Yes. Bonjela teething gel has been specially formulated so it is suitable to use on babies over 2 months. I does not contain choline salicylate, instead it contains lidocaine. - What is choline salicylate?
Salicylates are medicines that can relieve pain, inflammation and fever. Aspirin is an example of a salicylate that is taken orally. Choline salicylate has been used commonly for many years in products to relieve mouth ulcers and mouth pain. - What decision has been made by the Commission on Human Medicines (CHM) regarding choline salicylate?
The CHM has advised that no oral salicylate, including aspirin, should be given to children younger than 16 years, unless advised otherwise by a doctor. This advice is based on an association between oral salicylates and Reye's Syndrome - a very rare but serious condition that occurs mainly in children.
The CHM has now extended that recommendation and advised that topical choline salicylate products (ie those applied directly onto a body surface, such as mouth and gum gels) should no longer be given to children under 16 to remove mouth pain.
Further to this, the Medical and Healthcare Product Regulatory Agency has advised this is a precautionary measure only. There are no new safety concerns. The advice is being introduced due to a theoretical risk that these products could increase the possibility of a child developing Reye’s Syndrome – a rare but serious condition. - What is Reye's syndrome?
Reye's Syndrome is a very rare disease which affects the brain and liver and can be fatal. The risk is increased in children with fever, and who have taken a salicylate product. - What products contain choline salicylate/are affected by this change?
Choline salicylate is the main ingredient in two common treatments for mouth ulcers/gum irritation on the market - bonjela and bonjela Cool Mint gel.
NB: bonjela Teething Gel does not contain choline salicylate, is suitable for use in babies and children over 2 months, and is not affected by this change. - How can I be sure I use the correct product with my child?
We have completely re-designed the bonjela range to ensure you are easily directed to the most appropriate product for your needs.
- I have been using bonjela products regularly with my children - should I be concerned?
Reye's Syndrome is a very rare problem and if you previously used bonjela or bonjela Cool with your children, and they have experienced no reaction, then they are fine, and there is nothing to worry about.
With children, use Bonjela Teething gel instead, since it does not contain salicylates.
However, as with any health issue, should you have any concerns you should discuss these at once with your GP, pharmacists or health visitor. - What about bonjela Once? Does that contain choline salicylate? Is it suitable for use with children under 16?
bonjela Once is a medical device used to treat mouth ulcers. It does not contain choline salicylate. It remains effective for mouth ulcer treatement in adults and children over 12. It is not affected by this issue.
- bonjela and bonjela Cool Mint gel are products indicated for mouth ulcers in adults from 16 years of age and above.
- bonjela Teething gel is indicated for Teething pain relief. Suitable for babies over 2 months of age.
- Always read the label.
