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Following further investigation of this issue, the TGA has undertaken recalls of multiple products.
The Therapeutic Goods Administration (TGA) is warning consumers and health professionals that listed medicines containing herbal ingredients from the Artemisia species may pose a risk during pregnancy.
A number of Artemisia species are permitted for use in listed medicines in Australia. These medicines are available from a range of suppliers including through health food stores and Traditional Chinese Medicine (TCM) practitioners. Artemisia species have been traditionally used for a variety of conditions, many of which relate to the gastrointestinal system and certain infections.
Artemisinin is a chemical found in many Artemisia species and is present at relatively high levels in Artemisia annua, a species that is currently permitted for use in listed medicines. Compounds related to artemisinin are used in some prescription medicines. These prescription medicines are not recommended for use in pregnant women, particularly during the first three months of pregnancy.
The TGA is aware of evidence that indicates the use of Artemisia species in listed medicines may also be unsafe during pregnancy. Extracts from Artemisia annua have been shown to harm the developing embryo in animals. These types of studies are used to identify risks for medicines used during pregnancy in humans. Studies of artemisinin and related compounds have also shown the potential for both pregnancy loss (miscarriage) and developmental abnormalities in animals.
In light of this, the TGA is advising that medicines which contain Artemisia ingredients should not be taken by women who are pregnant, think they may be pregnant, or intend to become pregnant.
The TGA is currently further investigating this issue. This investigation will consider the level of risk associated with different Artemisia species. The TGA anticipates that new requirements will be introduced to warn consumers of the potential risk during pregnancy.
The TGA is aware that some products containing Artemisia species already advise consumers to not take these products during pregnancy. To date, the TGA has not received any adverse event reports related to the use of listed medicines containing Artemisia species during pregnancy.
The following Artemisia species are currently permitted for use in listed medicines in Australia and will be considered in the TGA investigation:
| Artemisia species currently included in listed medicines | Other Artemisia species permitted for use in listed medicines |
|---|---|
| Artemisia absinthium (also known as Absinth, Absinth sagewort, Wormwood) | Artemisia abrotanum (also known as Southern wood) |
| Artemisia annua (also known as Chinese wormwood, Annual wormwood, Sweet wormwood, Sweet Annie, Quinghao) | Artemisia arborescens (also known as Mediterranean Artemisia, Artemisia tree) |
| Artemisia argyi (Aiye, Argy wormwood leaf, Chinese Artemsia, Chinese mugwort) | Artemisia dracunculus (also known as Estragon, French Tarragon, Tarragon) |
| Artemisia frigida (also known as Fringed sagebrush, Prairie sagewort, Wormwood-sage, North American Artemisia, Siberian artemsia) | Artemisia maritima (also known as Sea wormwood) |
| Artemisia herba-alba (also known as Sheih, North African Artemisia) | Artemisia pallens (also known as Davana) |
| Artemisia vulgaris (also known as Mugwort) | Artemisia tridentata (also known as Sagebrush) |
Information for consumers
If you are a woman and are taking, or are considering taking, products containing any of the Artemisia species listed above, please be aware of the potential risks during pregnancy.
You should stop using products containing any of the Artemisia species listed above if you are pregnant or if becoming pregnant is a possibility. The risks are higher during early pregnancy, including the time prior to a new pregnancy being identified.
If you have any concerns or questions about this issue, speak to your health professional.
Information for health professionals
Please be aware that products containing Artemisia species may pose a risk if used during pregnancy. As such, they should not be taken during pregnancy, or if there is a possibility of becoming pregnant. Ask patients who are pregnant or planning a pregnancy about use of complementary medicines. Advise patients who are pregnant or planning a pregnancy not to take products containing Artemisia species.
Information for sponsors
Sponsors are reminded of their obligation to comply with the requirement that listed medicines must be safe for their intended purpose. Sponsors are expected to address any identified safety concerns for their product(s), even if product(s) are compliant with other requirements. Failure to do so could lead to regulatory action, which may include the recall and/or cancellation of a product.
Sponsors are also reminded of their obligation to report all serious adverse events to the TGA within required timeframes.
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.