19 September 2019
The sponsor has cancelled Arthrem capsules from the Australian Register of Therapeutic Goods, meaning that it can no longer be legally supplied in Australia. In addition, a retail level recall was undertaken in relation to this product on 5 September 2019. Further information can be found on the System for Australian Recalls Actions (SARA) database.
The above actions address the safety concerns detailed below. The TGA will continue to monitor the safety of the active ingredient, Artemisia annua, and take further actions for other products as necessary.
Safety advisory - potential risk of harm to the liver
19 March 2018
Consumers and health professionals are advised that the TGA is monitoring the safety of Arthrem capsules.
Arthrem caspules are a complementary medicine listed on the Australian Register of Therapeutic Goods (ARTG) and are marketed as a natural dietary supplement for maintaining and supporting joint health and mobility. Arthrem capsules contain the herbal ingredient Artemisia annua extract as the only active ingredient.
The TGA is monitoring Arthrem capsules due to identification of a safety concern regarding this product and the potential risk of harm to the liver. The New Zealand therapeutic goods regulator, MedSafe, has published an alert regarding Arthrem. MedSafe has received 14 reports of liver toxicity associated with the use of Arthrem.
Medsafe also reported the findings of a 12-week pilot study involving Arthrem. 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. The recommended dose on the product label is one 150 mg capsule twice daily.
To date the TGA has not received any reports of adverse events associated with Arthrem capsules. However, consumers should be aware of a potential risk of harm to the liver when taking these products.
In response to this issue, the sponsor of Arthrem capsules, Promisia Australia, is undertaking the following actions:
- updating all medicine labels with the following caution – 'in rare circumstances Artemisia annua may be associated with liver harm'
- providing an update to all pharmacies that stock Arthrem capsules
- updating their website to note the risk of liver harm and the symptoms to look out for, as well as instruction that, in the event of these symptoms being observed, to stop taking Arthrem capsules and consult a doctor
- amending messaging on labels, point-of-sale material and so on to stress that the product must be taken strictly as directed.
The TGA is continuing to monitor the safety of Arthrem capsules and encourages consumers and health professionals to report any suspected problems associated with Arthrem, especially any cases relating to the liver, to the TGA.
Information for consumers
If you or someone you provide care for has been taking Arthrem capsules please be aware of this issue.
If you develop any of the following problems, stop taking Arthrem capsules and contact your doctor as soon as possible:
- stomach pain
- pale stools
- dark urine
- itching all-over
- the whites of the eyes have turned yellow or the skin is yellow (jaundice).
If you have any questions or concerns about this issue, contact your health professional.
If you suspect you have had a side effect to Arthrem capsules, please report it to the TGA.
Information for health professionals
If you are treating a patient who has used Arthrem capsules, please be aware of this issue.
Patients who develop signs of liver problems should be advised to cease this medication immediately and be followed up appropriately.
Please report any suspected problems associated with Arthrem capsules, especially any cases related to the liver, to the TGA. This will assist the TGA to continue to monitor the safety of this product.
|||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|
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.