Summary Safety Review - Artemisia annua -containing Products - Assessing the Potential Risk of Liver Injury

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2021-03-24

Product

Artemisia annua-containing products (also known as Sweet wormwood-containing products)

Potential Safety Issues

Risk of liver injury

Key Messages

  • Artemisia annua-containing products are natural health products authorized for sale in Canada for various indications such as the relief of cold symptoms or occasional constipation, or for symptom management of diarrhea.
  • Health Canada reviewed the potential risk of liver injury with the use of Artemisia annua-containing products. This safety review was triggered by public advisories issued by MedSafe of New Zealand and by the Therapeutic Goods Administration (TGA) of Australia related to the potential risk of liver injury with the use of Artemisia annua-containing products available in those countries.
  • Health Canada's review of the available information could not confirm a link between the use of Artemisia annua-containing products and the risk of liver injury in Canada. At the time of this review, Health Canada found that the available information for Artemisia annua-containing products related to this risk in Canada is too limited to warrant regulatory action.
  • The Artemisia annua-containing products of concern in New Zealand and Australia are not marketed in Canada. In contrast to the reported uses in New Zealand and Australia (chronic joint pain), the reported uses in Canada are different and typically of shorter duration (1 to 8 weeks). Health Canada will continue to monitor the safety of Artemisia annua-containing products in Canada.

Overview

Health Canada reviewed the potential risk of liver injury with Artemisia annua-containing products. The review was triggered after the New Zealand Medicines and Medical Devices Safety Authority (MedSafe)1 and the Therapeutic Goods Administration of Australia (TGA)2 published risk communications to advise consumers and healthcare professionals about the potential risk of liver injury with the use of products containing Artemisia annua extract.

Use in Canada

  • Artemisia annua-containing products are natural health products (NHPs) authorized for sale in Canada for various indications such as, the relief of cold symptoms or occasional constipation, or for symptom management of diarrhea.
  • Artemisia annua-containing products have been authorized in Canada under several brand names. There are over 160 authorized Artemisia annua-containing NHPs available in several dosage forms that include tablets, capsules, granules, powders, and oral drops. Over 40 of these products contain Artemisia annua as the only (single) medicinal ingredient.
  • The Artemisia annua-containing products of concern in New Zealand and Australia are not marketed in Canada. In contrast to the reported uses in New Zealand and Australia (chronic join pain), the reported uses in Canada are different and typically of shorter duration (1 to 8 weeks).
  • In Canada, Artemisia annua-containing products can be accessed by individuals without a prescription for self-administration.

Safety Review Findings

  • Health Canada reviewed the available information from published clinical studies as well as case reports of liver injury from the Canada Vigilance databasea and international databases.
  • At the time of the review, Health Canada had received 4 Canadian reports of liver injury potentially related to the use of Artemisia annua-containing products. Health Canada's review of these case reports did not find a link between the products and liver injury due to a lack of detailed information in these reports.
  • A review of 61 international cases of liver injury related to the use of an Artemisia annua-containing product was also completed. The assessment was unable to determine a link between potential risk of liver injury and the use of Artemisia annua-containing products due to insufficient information within these case reports.
  • The mechanism by which Artemisia annua could cause liver injury is not well understood.

Conclusions and actions

  • Health Canada's review of the available information could not confirm a link between the use of Artemisia annua-containing products and the risk of liver injury in Canada. At the time of this review, Health Canada found that the available information for Artemisia annua-containing products related to this risk in Canada is too limited to warrant regulatory action.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of Artemisia annua-containing products to the Canada Vigilance Program.
  • Health Canada will continue to monitor safety information involving Artemisia annua, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information and what is known about the use of this natural health product both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

  1. Artemisia annua (Sweet wormwood, Sweet Annie, Qing hao) extract marketed as Arthrem: risk of harm to the liver - statement under section 98 of the Medicines Act 1981; Medsafe
  2. Arthrem capsules Safety advisory - potential risk of harm to the liver

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Online Database

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