Safety Information

Early Warning System - Alert Communication

Arthrem – potential risk of harm to the liver – statement under section 98 of the Medicines Act 1981

15 February 2018

Products Affected
Information for consumers and caregivers
Information for healthcare professionals
Data Summary
What actions are Medsafe taking?
How to report adverse events
Further information

Arthrem is marketed as a natural dietary supplement for maintaining and supporting joint health and mobility. Arthrem soft gel capsules contain 150 mg of Artemisia annua extract in grape seed oil. The Centre for Adverse Reactions Monitoring (CARM) has received 14 reports of liver toxicity associated with the use of Arthrem. To date all the reports of harm to the liver have involved patients taking Arthrem specifically. Since the chemical composition of the Artemisia annua extract is not disclosed it is not clear if other products containing Artemisia annua extract have similar effects.

Consumers should be aware of a potential risk of harm to the liver when taking these products.

Products Affected

Arthrem soft gel capsules 150 mg


 

Information for consumers and caregivers

  • Arthrem is not an approved medicine.
  • Medsafe has received information that suggests Arthrem may cause harm to the liver in some patients who use this product.
  • If you develop any of the following problems: 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), stop taking Arthrem and contact your doctor as soon as possible.
  • Always tell your healthcare professional if you are taking any dietary supplements or herbal products and talk to them if you have any concerns.
  • If you suspect you have had an adverse reaction to Arthrem or any other natural health product, report it to the Centre for Adverse Reactions Monitoring (CARM). Please see below for how to report. 

 

Information for healthcare professionals

  • Liver toxicity, including hepatitis, abnormal liver function and jaundice, has been reported in patients taking Arthrem.
  • Consider Arthrem (or other products containing Artemisia annua) as a possible cause of liver toxicity.
  • Advise patients/consumers experiencing liver problems and taking Arthrem or other natural health products, to stop taking the product and contact their GP.
  • Report any suspected adverse reactions to Arthrem or any other natural health products to the Centre for Adverse Reactions Monitoring (CARM). Please see below for how to report. 

Data Summary

CARM has received 14 reports of liver toxicity associated with the use of Arthrem, from February 2016 up until 31 December 2017. 

Many of the reports included jaundice as a reaction. Where information was provided (liver function tests and biopsy results), the pattern of liver toxicity was either hepatocellular or mixed (hepatocellular and cholestatic). All of the patients stopped taking Arthrem and at the time of reporting most had already recovered or were improving.

Arthrem has been studied in a 12-week pilot study1. During the study, one of 14 patients who took Arthrem 300 mg twice per day developed hepatitis, which was considered by the study investigators to be possibly related to Arthrem.

What actions are Medsafe taking?

Medsafe will continue to monitor the safety of Arthrem.

How to report adverse events

Phone + 64 3 479 7247 to speak to a Medical Assessor at the Centre for Adverse Reactions Monitoring (CARM)
  From your iPhone using the ADR online app
Online Submit a report to CARM
Prescribers can submit using the online reporting tool available in patient management software
Yellow Card A completed Yellow card can be submitted to CARM via email, fax or mail
Email carmnz@otago.ac.nz
Fax +64 3 479 7150

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Further information

Total Number of reports received for Arthrem at 31 December 2017: 20

Number of reports of patients experiencing a hepatic reaction: 14

Number of hepatic reactions: 33

Table 1: Summary of Cases reported to CARM linking Arthrem with harm to the liver 
CARM Report ID Patient Age/Gender Medicines reported Reactions Reported
119615 71/M Arthrem*
Pantoprazole
Atorvastatin
Cilazapril/hydro-chlorothiazide
Fluoxetine
Terazosin
Finasteride
Ibuprofen
Febuxostat
Lesinuride
Hepatic enzymes increased
120445 48/F Arthrem*
Diltiazem
Cilazapril
Nortriptyline
Paracetamol
Magnesium
Hepatic enzymes increased
Abdominal pain
Nausea
Fever
122052 54/F Arthrem* Hepatitis
Jaundice
Pruritus
123150 76/F Arthrem* Jaundice
Pruritus
Hepatitis
124405  67/F Arthrem* Hepatic function abnormal Jaundice
Pruritus
124539  72/F Arthrem* Hepatic enzymes increased Jaundice
124873  55/F Arthrem*
Felodopine
Hepatitis
Jaundice
Nausea
Fever
125378  62/M Arthrem*
Atorvastatin
Omeprazole
Candesartan
Hepatitis
125847  66/F Arthrem* Hepatic function abnormal Jaundice
125947  64/F Arthrem* Nausea
Vomiting
Hepatic enzymes increased
125969  76/F Arthrem* Jaundice
Hepatic function abnormal
125970  77/M Arthrem* Jaundice
Hepatic function abnormal
126905  55/M Arthrem*
Metoprolol*
Jaundice
Hepatic enzymes increased
126933  71/F Arthrem* Jaundice
Hepatic enzymes increased

*suspect medicine

References
  1. Stebbings S, Beattie E, McNamara D, et al. 2016. A pilot randomized, placebo-controlled clinical trial to investigate the efficacy and safety of an extract of Artemisia annua administered over 12 weeks, for managing pain, stiffness, and functional limitation associated with osteoarthritis of the hip and knee. Clinical Rheumatology 35: 1829-36