Meds get new names in TGA alert


Schedule 3 - pharmacist holding out pill bottles

The TGA is updating the names of several medicine ingredients to align with names used globally, it reports in today’s Medicines Safety Update.

Some medicine ingredient names in Australia have become out of date over the years, the TGA says.

There will be a four-year transition period for the changes, to April 2020.

The list of changes is available here.

“Some changes are minor, for example changing a ‘y’ to an ‘i’, and will not affect how the ingredient name is pronounced,” it says.

“Some changes are more significant. For these products, medicine labels will need to use both the old and new ingredient name for an additional three years after the end of the transition period (until 2023). This will help consumers and health professionals become familiar with the new name.”

From this month, new ingredient names will start to appear on labels, in CMIs and product information, as well as within medication software systems.

The TGA is asking health professionals to be particularly careful when prescribing or dispensing these medicines, as labels using the old names will still be on-shelf during the transition period as older stock is sold.

They are also asking health professionals to reassure patients that only the names of ingredients have changed.

  • Adrenaline and noradrenaline will remain as approved names in Australia – there is no plan to update these to epinephrine and norepinephrine, the TGA says. Instead, labels of medicines containing adrenaline or noradrenaline will include the international name (epinephrine and norepinephrine, respectively) in brackets after the ingredient name. This information will be included on labels indefinitely.

The TGA is asking health professionals to be particularly careful when prescribing or dispensing these medicines, as labels using the old names will still be on-shelf during the transition period as older stock is sold.

More changes

  • Xgeva (denosumab) is now contradicted in patients with unhealed lesions from dental or oral surgery due to increased risk of osteonecrosis of the jaw.
  • Erlotinib has had a change of indication. A study has found no demonstrable benefit of first-line maintenance treatment versus second-line treatment with erlotinib for patients whose tumours do not harbour an epidermal growth factor receptor-activating mutation. Consequently, the indication for this medicine has been updated.
  • The Product Information for ibrutinib has be updated with new safety information relating to the risk of hepatotoxicity.

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