Codeine safety update

little boy crying on father's shoulder

The TGA has warned against using codeine in children under 12

In its latest Medicines Safety Update, the TGA has advised that the recommendations of its safety review of codeine use in children and rapid metabolisers have been implemented.

PI documents for all prescription products have been updated to reflect the review’s findings.

This means that 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.

It also means codeine should no longer be used by breastfeeding mothers, or known ultra-rapid metabolisers of the drug.

The TGA has also identified a “small number” of OTC products containing codeine – all of which are tablets – that are currently being marketed and still have dosage instructions for children aged between six and 12.

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.

“Please be mindful of these changes, especially during the transition period for the rescheduling of these products, and advise patients accordingly,” says the TGA.

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