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: o People who have elevated liver enzymes, liver disease or liver cancer o Anyone who is pregnant, planning to become pregnant or breastfeeding o People who are taking antiretroviral drugs for HIV o Anyone who is taking drugs that are known to prolong QT interval o 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): o nausea (feeling sick) o stomach pain o pale stools o dark urine o itching all-over o the whites of the eyes have turned yellow or the skin is yellow (jaundice) Rene de Wit Chief Executive 021 571000 End CA:00327473 For:PIL Type:GENERAL Time:2018-11-27 16:12:55