Artemisia annua extract to become prescription-only medicine

Artemisia annua extract is being classified as a prescription medicine from today, following a recommendation from the Medicines Classification Committee (MCC).

The new classification means it will no longer be able to be sold in pharmacies or online.

This classification affects the artemisia annua extract only, not the plant.

Medsafe’s Group Manager Chris James says the change now means all products containing artemisia annua extract can only be supplied on a prescription given by a health care professional authorised under the Medicines Act 1981. There are no approved products containing artemisia annua extract currently.

‘We also want to make it clear that these products are not currently approved prescription medicines – they remain unapproved despite today’s change and because of this can only be prescribed by a medical practitioner. That means they haven’t been assessed for their pharmaceutical quality and safety.

‘Medsafe and the Director-General have previously issued two safety alerts associated with artemisia annua extract and this change in classification is to address safety concerns with Artemisia annua extract.

Mr James says Medsafe published alerts in February 2018 and November 2018 advising members of the public taking Arthrem, a product containing artemisia annua extract, of a potential risk of harm to the liver.

‘Our advice then was the same as it is now – stop taking the product and seek medical advice if you develop nausea, stomach pain, all-over itching, jaundice, dark urine or pale stools. If you have any questions or concerns, discuss these with your health care professional,’ Mr James says.

Anyone who suspects they have experienced an adverse reaction to these products are encouraged to report these to the Centre for Adverse Reactions Monitoring (CARM). Information about how to report a problem can be found on the Medsafe website.

The Gazette notice is available on the NZ Gazette website.

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