“Unacceptable risk in pregnancy”: Bioceuticals and Integria Healthcare artemisia products among TGA recall list
FIT-BioCeuticals had four batches of its Paracea Forte recalled, while one batch of MediHerb Stealth Complex from Integria Healthcare was recalled.
The other two companies affected were Gloria Herbs and Herbal Supplies. The former saw a batch of its liver detox product recalled, while the same happened for 10 batches of the latter’s Hilde Hemmes’ Herbals Wormwood Herb.
No consumer complaint on the products has been lodged so far.
However, these products contain Artemisia annua and Artemisia absinthium – which the TGA said were artemisia species that contain higher levels of artemisinin.
Artemisinin has been associated with miscarriage, according to existing animal studies.
“Animal studies of Artemisia annua extracts, artemisinin and related compounds have shown the potential for both pregnancy loss (miscarriage) and developmental abnormalities in animals.
“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.
“As these products do not warn consumers against their use during pregnancy, they are being recalled,” TGA said.
Of the four products, Herbal Supplies’ Hilde Hemmes’ Herbals Wormwood Herb contains the highest amount of artemisia extract.
Its product summary on ARTG shows that it contains one gram of Artemisia absinthium herb top flowering dry as the active ingredient.
This is followed by Integria Healthcare’s MediHerb Stealth Complex, with each of its tablet containing 266.66mg of Artemisia annua herb extract dry concentrate.
FIT-BioCeuticals’ Paracea Forte tablet contains 187.5mg of Artemisia annua herb extract dry concentrate standardised, while Gloria Herbs’ liver detox contains 98mg of Artemisia absinthium leaf extract dry concentrate.
The four products have been registered with the TGA for several years, with Hilde Hemmes’ Herbals Wormwood Herb registered since 1997, Gloria Herbs live detox registered since 2015, and the remaining two since 2017.
These products are allowed to make a range of permitted indications associated to maintaining/supporting general health and wellbeing, while some could make claims on reliving diarrhoea/loss of appetite.
NutraIngredients-Asia has contacted the companies for comments.
One of the firms, Integria Healthcare issued an official statement, stating that the product involved will not be reformulated, and will be available pending a label change in line with the TGA's directive on the matter.
The regulator said in last October that it has been keeping tabs on listed medicines containing 12 artemisia species, following scientific reports on how intake of the botanical could lead to miscarriages.
Warnings needed
The TGA now requires all listed medicines containing Artemisia annua and Artemisia absinthium to state warnings against use during all stages of pregnancy.
A search on the ARTG shows that there are currently 53 listed medicines containing one or both of the ingredients.
Aside from the two, four other types of artemisia species are already used in current listed medicines registered with the TGA.
They are Artemisia argyi, Artemisia frigida, Artemisia herba-alba, and Artemisia vulgaris.
