In a medicine safety update issued on July 7, the Australian regulator, the Therapeutic Goods Administration (TGA), noted that cases of liver injury linked with herbal preparations containing ashwagandha (W. somnifera) continue to be reported both in Australia and internationally.
The regulator first issued a 2024 advisory following a safety review prompted by a 2021 adverse event report of a serious liver injury associated with a listed medicine containing ashwagandha.
“Since the publication of the TGA’s 2024 safety advisory, we have received a further 4 adverse event reports with enough information to suggest a possible liver injury that may have been caused by medicines containing W. somnifera," the TGA stated.
All of these latest cases were resolved on discontinuation of the suspected product, and none reported requiring hospitalization.
Compounding global evidence and regulatory scrutiny
Ashwagandha, an herb long valued in Ayurveda and other traditional medicine systems, is commonly used to support sleep and relaxation.
As of July 17, the Australian Register of Therapeutic Goods (ARTG) listed 91 complementary medicines or health supplements containing ashwagandha, with the TGA noting that most use concentrated extracts derived from the root, while the leaf component is less commonly used. It has also advised against purchasing supplements online as they are not regulated for quality, safety or effectiveness in the country.
The latest safety update brings the total number of possible ashwagandha-related liver injury reports received by the TGA to 11. Of these, six cases had no other ingredients considered likely to have contributed to the liver injury, and in four of these six cases, the suspected ashwagandha-containing products were listed on the ARTG. Two of these four cases required hospitalization.
While no fatalities or liver transplants have been reported among Australian consumers, the TGA cites evidence of at least four published international literature reports associated with ashwagandha. One of these cases required a liver transplant.
It also referenced reports of three fatalities among patients in India with acute or chronic liver failure associated with single-ingredient ashwagandha preparations.
Further regulatory action and the weight of the evidence
Looking ahead, TGA said that it would continue to assess the weight of emerging evidence to determine whether regulatory action is required.
“The available evidence indicates that while the risk appears to be very rare, there is a potential for liver injury associated with the use of this herbal ingredient,” it stated.
Against this backdrop of regulatory scrutiny, the Australian complementary medicines industry will be convening this week to discuss next steps. In parallel, ashwagandha stakeholders met with policymakers at the European Parliament last week to consider whether ashwagandha should undergo an Article 8 review in Europe—a process that if initiated by the European Food Safety Authority (EFSA) could lead to restrictions, label requirements or a ban if safety concerns are identified.
The meeting, organized by Kerry Group and hosted by Member of the European Parliament Sean Kelly, also marked the formal launch of Safeguard Ashwagandha, an initiative that seeks to ensure that the extensive body of peer-reviewed safety data informs regulatory decisions.
The platform launched shortly after the Food Safety and Standards Authority of India (FSSAI) issued an April 16 ban restricting the use of ashwagandha in supplements to the root and root extracts can be used in supplements, prohibiting the use of leaves and leaf extracts.
