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Update - recommendations implemented
Consumers and health professionals are advised that the recommendations of the safety review of codeine use in children and rapid metabolisers have now been implemented.
The Product Information (PI) documents for all prescription codeine products have been updated to reflect the findings of the TGA's safety review.
Specifically, codeine products should no longer be used in children under 12 years of age, or in children aged 12-18 years who have recently undergone surgery to remove their tonsils or adenoids.
Codeine should also not be used by breastfeeding mothers or in patients known to be ultra-rapid metabolisers.
Most PIs for over-the-counter codeine products now have warnings to not use these products in children aged under 12 years.
From 1 February 2018, all Schedule 2 (Pharmacy Medicine) and Schedule 3 (Pharmacist Only Medicine) codeine-containing products will be rescheduled to Schedule 4 (Prescription Only Medicine).
In the meantime, the TGA has identified a small number of over-the-counter codeine products, all of which are tablets, that are currently being marketed and still have dosage instructions for children aged 6-12 years. The sponsors of these products have written to pharmacists to inform them of the relevant safety information including that these products should not be used in children under 12 years of age.
Safety review: Codeine use in children and ultra-rapid metabolisers, Version 1.0, October 2015
1 October 2015
The TGA has carried out a safety review into codeine use in children and rapid metabolisers.
The review concerned the safety of use of all codeine-containing products in children and breast-feeding mothers, in the context of genetically determined rapid metabolism of codeine to morphine.
The issue of codeine use in children has also been considered recently by the following:
- The Advisory Committee on the Safety of Medicines (ACSOM) considered the review and recommendations at its meeting on 10 July 2015. The ACSOM meeting statement has been published on the TGA website.
- The scheduling delegate considered the issue as part of the consideration of the scheduling of codeine. The interim scheduling decision on codeine and its reasons with invitation for further comment have been published on the TGA website.
As the final decision on the scheduling of codeine will impact on implementation of the recommendations contained in the TGA safety review, TGA will undertake consultation with stakeholders once the final scheduling decision is published.
Safety review
This review concerns the safety of use of all codeine-containing products in children and breast-feeding mothers, in the context of genetically determined ultra-rapid metabolism of codeine to morphine.