|Date:||23 Apr 2009|
|Subject:||New advice on oral salicylate gels in under 16s|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
The Medicines and Healthcare products Regulatory Agency (MHRA) is issuing precautionary advice for topical oral pain relief gels containing salicylate salts.
The main products affected are Bonjela and Bonjela Cool Mint Gel. The new advice recommends these products are not used in those under 16-years-of-age. This is due to salicylate salts having the same effect on the body as aspirin which is already contraindicated in children and young people under 16-years-of-age.
This is a precautionary measure only and there are no new safety concerns. The advice is being introduced due to a theoretical risk these products could increase the possibility of a child developing Reye’s syndrome – a rare but serious condition.
There are a number of options and alternative treatments for pain associated with teething and mouth ulcers. If parents, carers or young people are unsure how best to treat these problems they should ask a GP, health visitor, dentist or pharmacist for advice.
MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said this new advice brings these products into line with others containing aspirin.
“Any risk from these oral gel products is theoretical. We are not aware of any confirmed cases, but when there are alternatives available, any risk is not worth taking.
“The new advice is to stop using these products in children and young people under 16, and to use alternative treatments. For infants with teething there is helpful advice in the Department of Health’s Birth to Five publication.”
Notes to Editor
1. Reye’s syndrome is a very rare condition that causes serious liver and brain damage. Almost all recorded cases of Reye’s syndrome have occurred in children. The exact cause of Reye’s syndrome is unknown, but there is evidence that two factors may contribute towards children developing the condition; previous viral infection, such as influenza (flu) or chickenpox and exposure to Aspirin. Due to the possible link between Reye’s syndrome and aspirin, the Medicines and Healthcare products Regulatory Agency (MHRA) recommended that children who are under 16 years of age should not take aspirin, unless it is on the advice of a doctor.
2. There have been no confirmed cases of Reye’s syndrome associated with Bonjela/Bonjela Cool. As of 16 April 2009, a total of three suspected serious Adverse Drug Reactions (ADR) reports have been received by the MHRA in association with the use of topical oral gels containing choline salicylate such as Bonjela. All three cases were in children and resulted in hospitalisation. In all three cases, Reye’s syndrome was suspected but in none of the cases was Reye’s syndrome confirmed. In addition to these serious cases we have four reports of vomiting or diarrhoea in children following the use of Bonjela. In three of these cases Bonjela was being given for teething pain. In all cases, the children recovered completely. It is important to note that a report of a suspected adverse drug reaction does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and the underlying disease.
3. There are a number of options and alternative products which can be used to treat pain associated with infant teething and mouth ulcers. For infant teething gentle pressure with something cool such as a chilled teething ring may be helpful in relieving teething pain (http://cks.library.nhs.uk/patient_information_leaflet/teething (external link)).
Alternatively there are several dental gels available which contain a local anaesthetic/mild antiseptic which can be used to relieve the pain associated with infant teething and mouth ulcers. These alternative products do not contain a salicylate.
For pain associated with orthodontic devices, salt water mouthwashes are recommended for sore areas. For discomfort arising from tooth movement a paracetamol based painkiller is recommended.
If parents/carers/young people are in doubt over which treatment to use then they should consult their pharmacist, dentist, GP or health visitor.
4. Dinnefords Teejel Gel is a licensed product which contains choline salicylate but it is not currently marketed. There is one other product available called Pyralvex which is an oral paint indicated for denture pain and the relief of pain associated with mouth ulcers. 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.
5. Bonjela/Bonjela Cool are licensed treatments for mouth ulcers/gum pain in adults and young people of 16 years and above. Both products have also been repacked and are clearly now labelled ‘adult’ to avoid any confusion.
This change does not affect Bonjela Teething Gel which does not contain salicylates.
6. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.