Pregnancy warning


TGA now says artemisia containing products are not safe at any stage during a pregnancy as it expands product recall

There are now seven products undergoing a recall due to their containing high levels of Artemisia annua or Artemisia absinthium, as the Therapeutic Goods Administration issued new advice saying it may not be safe at any stage during a pregnancy.

The TGA had previously issued a recall notice for four products. Now its latest update, issued today (25 February) adds another three products to the warning. 

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

Previous TGA advice indicated that the risks of pregnancy loss (miscarriage) and developmental abnormalities, identified in animal studies, were likely to be higher in early pregnancy.

However, as its investigation has continued, the TGA now says it has “identified information that indicates the use of these medicines may be unsafe at all stages of pregnancy”.

The seven currently listed products “may expose consumers to unsafe levels of these ingredients during pregnancy when used as directed,” the TGA says.

“As these products do not warn consumers against their use during pregnancy, they are being recalled”.

The seven products currently listed by the TGA as undergoing a recall are:

Hilde Hemmes’ Herbals Wormwood Herb

 

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)

 

FIT-BioCeuticals Limited

191945, 192439, 200106, and 201215

15 February 2021

1300 650 455 (Ext 5) – BioCeuticals Recall Line

MediHerb Stealth Complex

 

Integria Healthcare Australia Pty Ltd

25048

15 February 2021

1300 654 336 – Integria Healthcare Clinical & Technical Support

Gloria Herbs – Liver Detox

 

Gloria Herbs Pty Ltd

11577

16 February 2021

0404 960 069 – Gloria Herbs Pty Ltd

IMMUNE RX

 

ATP Science Pty Ltd

Q00370 and 32926

19 February 2021

1300 767 110 – ATP Science Customer Support Team

Metagenics Parex and COSTAT

 

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

 

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