Understanding the Reclassification of Salicylate-Containing Products: Why Bonjela and Similar Remedies Are Now Pharmacy-Only in Australia

The reclassification of salicylate-containing products like Bonjela Teething Gel and Bonjela Mouth Ulcer Gel to Schedule 2 medicines in Australia marks a significant change in how these widely-used remedies are accessed by consumers. This move, effective from October 1, 2023, means that such products are now only available in pharmacies, where consumers can receive direct advice from pharmacists. The decision was primarily driven by concerns over the potential toxicity of choline salicylate, the active ingredient in these products.

Choline salicylate is a non-steroidal anti-inflammatory drug (NSAID) that has been used for years to relieve pain, inflammation, and discomfort associated with teething in infants and mouth ulcers in both children and adults. However, the TGA’s decision to up schedule these products to Schedule 2 was motivated by increasing evidence of the risks associated with their misuse, particularly in children. Overdose toxicity is a significant concern, especially when products are used more frequently or in larger amounts than recommended. This risk is heightened in children, who are more vulnerable to the effects of NSAIDs.

The TGA’s decision aligns with broader therapeutic guidelines in Australia, which have raised questions about the efficacy and safety of using teething gels, irrespective of their choline salicylate content. The guidelines suggest that alternative methods for managing teething discomfort, such as chilled teething rings or oral analgesics like paracetamol and ibuprofen, may be safer options for parents.

This reclassification also highlights a broader issue: the limited availability of effective, safe treatments for mouth ulcers, particularly for children. Mouth ulcers can cause significant discomfort and interfere with eating, drinking, and speaking, leading parents to seek out quick and effective remedies. However, with the reclassification of products like Bonjela, parents may find themselves with fewer over-the-counter options.

The limited treatment options for mouth ulcers underscore the need for products that are both safe and effective for all age groups. While the reclassification ensures that consumers receive professional guidance when using salicylate-containing products, it also places greater responsibility on healthcare providers to recommend suitable alternatives, particularly for young children who are most at risk of adverse effects.

The up scheduling of these products is a reminder of the delicate balance between ensuring access to effective treatments and safeguarding public health. As the TGA continues to monitor the safety and efficacy of over-the-counter medications, it’s crucial for consumers to stay informed and seek professional advice when managing common health issues like mouth ulcers.