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Various medicines containing Artemisia annua and Artemisia absinthium

Recalls due to unacceptable risk in pregnancy

25 February 2021

Consumers and health professionals are advised that multiple listed medicines are being recalled due to the presence of high levels of Artemisia annua or Artemisia absinthium. The medicines listed below pose an unacceptable risk if used during pregnancy.

The TGA published a safety advisory for listed medicines containing Artemisia species in October 2020. The safety advisory warned consumers of the potential risk of using these medicines during pregnancy.

The medicines being recalled are detailed in the table below. This table will be updated as recall actions are agreed with the TGA.

Product name (ARTG number) Sponsor Affected Batch numbers Date recall published Sponsor contact details

Hilde Hemmes' Herbals Wormwood Herb

(AUST L 62256)

Herbal Supplies Pty Ltd

56-61, 56-62, 56-63, 56-64, 56-65, 56-66, 56-67, 56-68, 56-69, 56-70

15 February 2021

08 8264 2453 - Herbal Supplies Pty Ltd

Paracea Forte Tablets (60)

(AUST L 290659)

FIT-BioCeuticals Limited

191945, 192439, 200106, and 201215

15 February 2021

1300 650 455 (Ext 5) - BioCeuticals Recall Line

MediHerb Stealth Complex

(AUST L 286616)

Integria Healthcare Australia Pty Ltd

25048

15 February 2021

1300 654 336 - Integria Healthcare Clinical & Technical Support

Gloria Herbs - Liver Detox

(AUST L 252038)

Gloria Herbs Pty Ltd

11577

16 February 2021

0404 960 069 - Gloria Herbs Pty Ltd

IMMUNE RX

(AUST L 328695)

ATP Science Pty Ltd

Q00370 and 32926

19 February 2021

1300 767 110 - ATP Science Customer Support Team

Metagenics Parex and COSTAT

(AUST L 298288 and 119573)

Metagenics (Aust) Pty Ltd

Parex Batches: 93301, 93302, 94351, 94352, 96177, and 96178 without pregnancy warning

COSTAT Batches: 92345 and 96440 without pregnancy warning

23 February 2021

1800 777 648 - Metagenics Customer Service

Artemisinin is a chemical found in many Artemisia species. Animal studies of Artemisia annua extracts, artemisinin and related compounds have shown the potential for both pregnancy loss (miscarriage) and developmental abnormalities in animals. These types of studies are used to identify risks for medicines used during pregnancy in humans.

The TGA investigation identified Artemisia annua and Artemisia absinthium as being 'high risk' as these species contain higher levels of artemisinin. Sponsors of medicines containing Artemisia annua and Artemisia absinthium were required to provide information to the TGA to enable an assessment of the risk of these products. Subsequently, the TGA identified that the above products may expose consumers to unsafe levels of these ingredients during pregnancy when used as directed. As these products do not warn consumers against their use during pregnancy, they are being recalled.

The TGA is also in the process of imposing conditions on all listed medicines containing Artemisia annua and Artemisia absinthium requiring warnings against use during pregnancy.

Previous advice published by the TGA indicated that the risks were likely to be higher in early pregnancy, including the time prior to a new pregnancy being identified. However, as the investigation has continued the TGA has identified information that indicates the use of these medicines may be unsafe at all stages of pregnancy.

Information for consumers

Please be aware that the products listed above pose an unacceptable risk if used during pregnancy.

You should stop using products containing any Artemisia species if you are pregnant or if becoming pregnant is a possibility. If you have any of the affected batch numbers of the medicines detailed in the table above, this remaining product can be returned to the place of purchase for a refund.

If you have any concerns or questions about this issue, speak to your health professional.

Information for health professionals

Please be aware of the above issue and advise patients accordingly if they seek advice.

If you have any questions or concerns about this issue, contact the relevant sponsor in the table above.

Reporting problems

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.