7 May 2009
MEDIA RELEASE
Update on the use of “teething” gels containing choline salicylate in children – results of Medsafe’s review
Please attribute to Dr Stewart Jessamine, Group Manager, Medsafe
In New Zealand two products contain choline salicylate, Bonjela Teething Gel and Bonjela Mouth Ulcer Gel.
Medsafe has now reviewed the available data and is satisfied that the safety of these products is acceptable when used
at the recommended dose. These products have been used in New Zealand for over 30 years and to date there have been no
reports of adverse reactions received by the Centre for Adverse Reactions Monitoring (CARM).
Data obtained from the New Zealand Poisons Centre has however highlighted that these products are sometimes used too
much and too often, and have been involved in a number of unintentional overdoses. Medsafe therefore takes this
opportunity to remind parents and carers about the importance of reading the information provided with the medicine and
adhering to the recommended dose. Parents and carers are also reminded to keep all medicines out of sight and reach of
children.
Parents and carers with any questions about the use of these medicines in children are recommended to talk to a
healthcare professional.
Notes to Editor
1. Medsafe has reviewed the data considered by the Medicines and Healthcare products Regulatory Agency (MHRA) that led
to the decision to contraindicate the use of topical oral choline salicylate gels in children under 16 years of age.
2. The MHRA review was based on a case published in the British Medical Journal in June 2008. The article described a
suspected case of Reye’s syndrome in a 20 month old child following the use of Bonjela oral gel. The MHRA concluded that
the symptoms described in this case could not be considered as Reye’s syndrome and were more likely due to salicylate
toxicity from overuse of the product. The MHRA decided to contraindicate the use of these products in children under 16
years of age due to a theoretical risk of Reye’s syndrome.
3. Medsafe’s advice follows a review of the MHRA decision, data obtained from the manufacturer of Bonjela, and data
obtained from CARM and the New Zealand Poisons Centre. Medsafe’s advice is consistent with that of the Irish Medicines
Board (IMB). As far as Medsafe is aware, the IMB is the only regulatory agency to release advice in response to the
MHRA’s decision to date.
4. The New Zealand Poisons Centre have advised Medsafe that they have received 279 calls relating to the use of these
products in children since 2002.
5. 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 cause of Reye’s syndrome is unknown, but there is evidence to suggest
that two factors may contribute towards children developing the condition; previous viral infection and exposure to
aspirin.
6. Please note that there is no evidence that links Reye’s syndrome to the use of choline salicylate containing products
such as Bonjela.
ENDS