Medsafe update

27 November 2018

The Ministry of Health (Medsafe) has today issued a renewed warning of the potential for liver harm
associated with taking of Artemisia annua extract and refers to Promisia’s product Arthrem.
The Medsafe statement gives the impression that since it issued an Alert on 15 February 2018
people taking Arthrem have continued to report adverse reactions.
Eleven newly reported adverse reactions, seven of those reactions relate to the period prior to the
15 February 2018 Medsafe Alert. These reports were prompted by the Medsafe Alert. This leaves
four reported adverse reactions occurring since February 2018 and one is of a highly questionable
nature for a response that has not been reported in any of the literature available to the company.
The three remaining instances may well not be Arthrem as they occurred at a time when competing
products with higher doses were still in the market. There have not been any reported adverse
reactions since April 2018.
Promisia has stated consistently that a significant majority of the reported adverse reactions cannot
be attributable to Arthrem. A number of competing products were introduced in 2017 and they
recommended a higher dose than that recommended for Arthrem. The introduction of these
competing products coincided with an increase in reported adverse reactions. There is incomplete
material in the reported adverse reactions and a number of them indicate clearly, based on reported
dosages, that the product was unlikely to have been Arthrem.
Promisia is always concerned about product safety. Arthrem is the world's only clinically trialled and
safety trialled joint support product that has Artemisia annua as its active ingredient.
Both trials were conducted by Otago University, with the results published in peer-reviewed journals
(Clinical Rheumatology and New Zealand Medical Journal). The clinical trial informed the product
formulation and dosage advice.
Consumers can be assured that it is perfectly safe to keep taking Arthrem provided the person is not
suffering adverse effects or has any contraindicated condition/s. However, Arthrem is not suitable
for:
 People who have elevated liver enzymes, liver disease or liver cancer
 Anyone who is pregnant, planning to become pregnant or breastfeeding
 People who are taking antiretroviral drugs for HIV
 Anyone who is taking drugs that are known to prolong QT interval
 Children
It is important that Arthrem is taken strictly as directed. Anyone experiencing any adverse reactions
should stop taking it immediately and consult with their doctor. Adverse reactions may include (but
are not limited to):
 nausea (feeling sick)
 stomach pain
 pale stools

 dark urine
 itching all-over
 the whites of the eyes have turned yellow or the skin is yellow (jaundice)

Rene de Wit
Chief Executive
021 571000