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Submission to the TGA regarding their new label warnings for artemisinin containing products

20.09.2021
Response to the proposed changes to requirements for listed medicine ingredients: annual low-negligible risk changes 2021-2022 / item 4: artemisinin and pregnancy risk.

the NHAA made the following submission to the TGA regarding their new label warnings for artemisinin containing products.

The NHAA Concludes:
Based on the lack of definitive human safety data required by the TGA on the intake of artemisinin from certain Artemisia species in the 1st trimester of pregnancy, and applying the precautionary principle for this vulnerable population group, the NHAA supports the addition of a warning statement on the medicine label “Do not use if pregnant or likely to become pregnant”. We would also like to highlight the following points:
Advice pertaining to herbal products be based on robust, expertly informed and relevant research evidence.
That the risks associated with products prescribed by health professionals are differentiated from products available for self-selection in a retail setting.

The NHAA appreciates the opportunity to contribute to the review of the proposed safety guidelines and in doing so, continue to support the health and wellbeing of pregnant women and their children in Australia.