TGA launches codeine safety review

Thursday, 18 Feb 2016


A review on the efficacy and safety of codeine will be undertaken to help determine whether the pain relief drug should be reclassified to prescription only.

Speaking during a Senate hearing Head of the TGA Professor John Skeritt said the information gathered from the review would feed into any final decision that was likely to be made in May this year.

“A review is planned over the next 6-8 weeks of the efficacy and safety of codeine especially at lower doses.

“In other words, whether OTC codeine is any better in pain relief than say a mixture of paracetamol and ibuprofen,” he told the committee.

Professor Skeritt told Senators the review was deemed necessary following an unprecedented response to the public consultation on the proposed rescheduling to prescription only.

The myriad of responses and views were ‘highly polarised” he said, noting that the AMA and the RACGP supported the upscheduling.

However he rejected suggestions from Senators that the rescheduling of codeine had become a pharmacist versus doctor issue.

If rescheduling went ahead it would take at least 12 months to implement, Professor Skeritt added.

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