Safety review: Codeine use in children and ultra-rapid metabolisers
Version 1.0, 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.