CHOLINE salicylate is an ingredient in a number of products for teething and the relief of pain, inflammation and discomfort associated with new dentures or braces and mouth ulcers and sores.
From 01 Oct, products containing choline salicylate for oromucosal or mouth use will only be available for purchase at pharmacies, the TGA has reported.
Customers may need to be informed that pharmacy medicines (Schedule 2 of the Poisons Standard) are those that may require advice from a pharmacist for safe use, and which should be available from a pharmacy or from a licensed person where a pharmacy service is not available.
In making this decision, the risks associated with prolonged use and overuse of choline salicylate, especially in children, were considered by the TGA.
The Therapeutic Guidelines in Australia do not recommend teething gels (irrespective of choline salicylate content) because of the lack of evidence of efficacy and the potential for harm.
The change was made in response to an application to amend the Poisons Standard, which was received in Jul 2021.
See the final decision to amend the Poisons Standard in relation to choline salicylate, HERE. JG
The above article was sent to subscribers in Pharmacy Daily's issue from 11 Sep 23
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