Bonjela Teething Gel and Bonjela Mouth Ulcer Gel — used to relieve the pain, discomfort and irritability associated with teething and mouth ulcers — will disappear from supermarket shelves from next month.
They’ll only be available at pharmacies, as the TGA reclassified the products from a Schedule 1 medicine to a Schedule 2 medicine, over concerns about toxicity levels following misuse.
The classification change for the go-to infant and toddler products means they will only be available for purchase in Australia at pharmacies from October 1.
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Woolworths has ceased orders for both products, and the remaining stock is expected to be sold out by the end of September.
Coles will also stop selling Bonjela and is currently running down stock.
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It comes amid concerns that the active ingredient — choline salicylate, which is a non-steroidal anti-inflammatory (NSAID) — can lead to toxicity when overdosed, which can occur when the products are not used as directed.
This can happen when too much of the product is used, when it is used too frequently, or when it is used over a long period of time.
A TGA spokesperson told 7NEWS.com.au: “Choline salicylate is an ingredient in a number of teething products such as Bonjela Teething Gel.”
“Other products for the relief of pain, inflammation and discomfort associated with mouth ulcers/sores and new dentures or braces also contain choline salicylate.”
This risk of overdose toxicity is greatest in children, according to pharmacist Alyssa Fusillo.
Bonjela Teething Gel and Bonjela Mouth Ulcer Gel will disappear from supermarket shelves from October 1. Credit: 7NEWS
She told 7NEWS: “This decision has been a long time in the making.”
“These things happen all the time with medicines. Once we get more information, scheduling can change.
The change was made in response to an application to amend the Poisons Standard, which was received in July 2021, and based on concerns about the risks associated with misuse and overuse.
A TGA spokesperson told 7NEWS.com.au: “Substances in Schedule 2 may require advice from a pharmacist for safe use, which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.”
“From October 1, 2023, products containing choline salicylate for oromucosal use (administered via the mucus systems in the mouth) will be pharmacy medicines (Schedule 2).”
The schedules go all the way up to 10 — Schedule 4 medicines require a prescription, and Schedule 10 medicines are: “Substances of such danger to health as to warrant prohibition of sale, supply and use,” the TGA website said.
Fusillo said that while the choline salicylate is safe at the recommended dose, it’s important that consumers have access to professional advice.
“The important thing with this medication, like any other medication, is to use it at the right time, the right frequency of dosing, and for the correct period of time.
“So with something like Choline Salicylate, it should be used no more than three hours, it shouldn’t be given more than six times in three hours, and it should not be used for longer than three days.”
The reclassification to a Schedule 2 medicine means parents will have access to professional advice each time they purchase the products. Credit: 7NEWS
For parents desperately trying to soothe teething pains beyond a three-day period, there are other options, Fusillo said.
“If parents are finding that they are needing to rely on this product for longer than that timeframe, they should be speaking to their pharmacist for further advice,” she said.
“We know that things like chilled teething rusks, and oral analgesics like paracetamol and ibuprofen can be beneficial, as well as distracting your little one and offering them other cool things like yoghurt.”
A TGA spokesperson told 7NEWS.com.au that the guidelines do not recommend teething gels, anyway.
”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,” they said.
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