Independent review of the efficacy and safety of over-the-counter codeine combination medicines

Consideration is currently being given to a codeine rescheduling proposal to up-schedule to Schedule 4 (S4) low dose codeine containing products currently available as S2 and S3 medicines.

To support this work, the TGA commissioned an independent review of the safety and efficacy of low dose codeine containing products. The Review was undertaken by Dr Christina Abdel Shaheed and Professor Chris Maher of the George Institute and Professor Andrew McLachlan of the University of Sydney.

The final report of the review is available on this website: Investigating the efficacy and safety of over-the-counter codeine containing combination analgesics for pain and codeine based antitussives

This review was among the information considered by the Advisory Committee on Medicines Scheduling (ACMS) at their meeting on 15 March 2016. For further information see the Update on the proposal to reschedule Codeine.

(Source: Australian Government – Department of Health)