Regulatory in brief | opioids, pholcodine, Arthrem

Regulatory in brief | opioids, pholcodine, Arthrem

23 September 2020 - Deborah Wilkes

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced stronger warnings for prescribed and OTC medicines containing opioids, while New Zealand’s Medsafe is to reconsider a recent recommendation for pholcodine and has reached a settlement over Arthrem.

UK regulator strengthens opioid warnings

The UK’s MHRA has introduced stronger warnings for prescribed and OTC medicines containing opioids that are used for treating non-cancer pain.

The regulatory agency said stronger warnings about the risk of dependence and addiction would be added to patient information leaflets and discussed with patients.

Healthcare professionals have been asked to discuss the warnings with any patient taking or planning to take an opioid-containing medicine. Discussions should involve agreement of a treatment plan, said the MHRA, including how long treatment should last to minimise the risk of dependence.

Furthermore, additional warnings are now to be added to the patient information leaflet to reinforce those warnings, making it clear that the medicine is an opioid which can cause addiction and that there can be withdrawal symptoms if people stop taking it suddenly.

Medsafe to reconsider pholcodine

New Zealand’s Medsafe has asked its Medicines Classification Committee (MCC) to reconsider a recommendation that pholcodine should be reverse-switched from pharmacy-only to pharmacist-only status.

The recommendation on the dry cough medicine followed a meeting of the MCC on 9 July 2020 (click here to read the News story).

Medsafe said it had received 72 objections to the recommendation from a range of objectors, and five of these were valid.

The MCC’s next meeting will be on 27 October 2020.

Medsafe reaches settlement on Arthrem

New Zealand’s Medsafe has withdrawn its prosecution of Promisia Integrative after the company agreed to stop selling Arthrem in the country.

Promisia accepted that it had breached the Medicines Act, said the regulatory agency, adding the company would now cease manufacturing, advertising and selling Arthrem.

Medsafe pointed out that promotional claims made by Promisia about Arthrem’s use for arthritis effectively made the product a medicine. Arthrem was unapproved, it explained, and was in breach of the Medicines Act.

The regulatory agency added that the Artemisia annua extract present in Arthrem had been linked to serious cases of liver harm.

Chris James, Medsafe’s group manager, said “a potentially harmful product was illegally marketed to the public as a dietary supplement, with fewer safety controls, when it should have been subjected to the more rigorous controls required for medicines”.

Promisia was first warned in 2016 that its advertising of Arthrem breached the Medicines Act.

As part of the settlement, Medsafe will withdraw nine charges laid in the District Court against the company last year.

James commented that a settlement was “seen as preferable given the length of time likely to be involved in pursuing a prosecution”.

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