Australian TGA Issues Updated Safety Warning on Ashwagandha and Very Rare Risk of Liver Injury
核心洞察
The Australian TGA reports a total of 11 possible liver injury (搜索) cases linked to ashwagandha-containing products, with 4 new cases since its 2024 safety advisory.
All four new cases resolved upon discontinuation without hospitalization, though two prior Australian cases required hospital care and one international case required a liver transplant.
The TGA states the risk appears "very rare" but will continue assessing emerging evidence to determine if further regulatory action is necessary.
The Australian Therapeutic Goods Administration (搜索) (TGA) has issued an updated medicine safety communication regarding the herbal ingredient ashwagandha (Withania somnifera), confirming that cases of liver injury (搜索) continue to be reported both domestically and internationally. The July 7 update brings the total number of possible ashwagandha-related liver injury reports received by the regulator to 11, with four new cases documented since the agency's initial 2024 safety advisory.
"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 (搜索) that may have been caused by medicines containing W. somnifera," the TGA stated. All four of these latest cases resolved on discontinuation of the suspected product, and none required hospitalization.
Growing Body of Evidence
The TGA's scrutiny of ashwagandha began following a 2021 adverse event report of a serious liver injury (搜索) associated with a listed medicine containing the herb. Of the 11 total cases now reported to the regulator, six had no other ingredients considered likely to have contributed to the liver injury. In four of these six cases, the suspected ashwagandha-containing products were listed on the Australian Register of Therapeutic Goods (ARTG), with hospitalization required in two instances.
While no fatalities or liver transplants have been reported among Australian consumers, the TGA cites evidence from published international literature documenting at least four cases associated with ashwagandha, one of which required a liver transplant. The regulator also referenced reports of three fatalities among patients in India with acute or chronic liver failure associated with single-ingredient ashwagandha preparations.
The Netherlands Pharmacovigilance Centre has published alerts reporting a total of 12 liver injury (搜索) cases up to June 2025, with time to onset varying from six weeks to 22 months. Most patients recovered after discontinuing the product.
Divergent Regulatory Perspectives
The safety assessment of ashwagandha is not uniform across jurisdictions. In 2024, India's Ministry of Ayush published an updated safety dossier on W. somnifera root, which found no evidence of intrinsic liver toxicity. The dossier commented that reported cases of liver injury (搜索) may be due to other causes or, at most, may rarely be idiosyncratic reactions requiring further investigation, concluding that W. somnifera root extract is safe for human consumption.
Notably, the use of W. somnifera leaves was recently banned in India, while root use remains permitted subject to prescribed limits. The TGA has indicated it is considering available evidence on the role of different plant parts in liver injury (搜索) and gastrointestinal adverse effects. Most listed medicines in Australia use concentrated extracts derived from the root, while the leaf component is less commonly used.
Regulatory Outlook and Industry Response
"The available evidence indicates that while the risk appears to be very rare, there is a potential for liver injury (搜索) associated with the use of this herbal ingredient," the TGA stated, adding that it will continue to assess emerging evidence and determine on the weight of evidence whether any regulatory action is necessary.
As of July 17, the ARTG listed 91 complementary medicines or health supplements containing ashwagandha. The TGA has advised against purchasing supplements online, noting they are not regulated for quality, safety, or effectiveness in Australia.
In parallel with the Australian regulatory activity, 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 (搜索) (EFSA), could lead to restrictions, labeling requirements, or a ban if safety concerns are identified. The meeting, organized by Kerry Group (搜索) and hosted by Member of the European Parliament Sean Kelly, also marked the formal launch of Safeguard Ashwagandha, an initiative seeking to ensure that peer-reviewed safety data informs regulatory decisions.
Call for Adverse Event Reporting
The TGA emphasized that its ability to monitor health and safety issues with herbal medicines depends in part on health professionals reporting adverse events. Just under half—five out of 11—of the possible liver injury (搜索) adverse event reports involving W. somnifera medicines were submitted by health professionals. The regulator strongly encourages health professionals to report any suspected adverse events associated with herbal medicines, noting that timely and accurate reporting enhances the ability to detect emerging safety signals and take appropriate regulatory action to protect public health.