PROMISIA, the NZ-based manufacturer of the Arthrem joint support product, has issued a statement in response to an updated Medsafe alert about the product (PD yesterday), noting that there had been no new Artemisia annua adverse reactions advised in the last seven months.
Following Pharmacy Daily's report yesterday, local representative Pharmabroker Sales contacted the supplier who provided additional information on the issue.
Promisia CEO Rene de Wit said the latest advisory notice could give the mistaken impression that there had been ongoing reports of adverse reactions since Medsafe issued its last alert in Feb 2018.
"Seven of the 11 newly reported adverse reactions since February relate to instances that happened before the February alert, but were reported afterwards," De Wit said.
Only four reported adverse reactions occurred after Feb, and it was not clear that these were linked to Arthrem because higher dose competitor products are still available on the market.
"In some instances it was not proven that products containing Artemisia annua (as opposed to another dietary supplement or medication that the person was also taking) caused the problem."
De Wit said when taken as directed Arthrem was safe and effective, adding that "safety is - and always has been - our top priority".
"Although one instance of liver harm is one instance too many, it is important to understand that adverse liver reactions caused by Artemisia annua are a very rare event," he said.
"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 conditions," de Wit added, however noting the product was not suitable for people with elevated liver enzymes, liver disease or liver cancer; those who are pregnant or breastfeeding; people taking antiretroviral drugs for HIV; children; or anyone taking drugs known to prolong QT interval.
More at arthrem.co.nz.
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