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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6 Comments

  1. Cameron Walls
    17/11/2017

    I’m still getting prescriptions for codeine to be used in children <12, both from the local hospitals and GPs. Perhaps there needs to be more information from the TGA directed towards doctors?

  2. Debbie Rigby
    19/11/2017

    Codeine-containing products – use in children and ultra-rapid metabolisers

    Health professionals are advised that the recommendations of a TGA 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.

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

    https://www.tga.gov.au/publication-issue/medicines-safety-update-volume-8-number-5-october-november-2017#codeine

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