TGA Ashwagandha Safety Update: What You Need to Know

The Therapeutic Goods Administration (TGA) has published a safety advisory regarding emerging
reports of gastrointestinal symptoms associated with the ingredient Withania somnifera (also known
as Ashwagandha). Some consumers experience mild gastrointestinal symptoms to herbal ingredients
including Withania. The TGA safety advisory reports that Withania somnifera has caused more
severe gastrointestinal symptoms such as nausea, vomiting or diarrhoea in some cases and in very
rare cases, possible liver injury.

The root of Withania somnifera has been traditionally used in Ayurvedic medicine for centuries for a
range of health benefits, and has gained wider use within traditional Western herbal medicine for
supporting resilience during stress, with scientific studies providing support for this use. Medicines
containing Withania somnifera including both the root and/or the leaves or other plant parts have
been permitted for use in Australia for over 30 years, for which there are around 370 products on the
Australian Register of Therapeutic Goods.

Complementary Medicines Australia (CMA) and our members are aware of national and international safety signals about the ingredient as part of regular monitoring activities and are continuing to investigate these concerns as part of our mission to promote high quality products and appropriate industry regulation.

In 2020, a major review was published of 20 randomised controlled trials examining the safety
and efficacy of Withania somnifera root with over a thousand participants. In 15 of these trials, no treatment related adverse events were reported. A small number of people in the other trials reported mild, mainly transient symptoms. The most common, experienced by less than 5% of people included stomach discomfort and loose stools, however with no serious adverse events. While several reports of liver injury within medical literature have been published more recently, a proportion of the individuals concerned had serious pre-existing liver conditions.

In 2023, a review examined three studies which measured liver enzymes and found they remained within the healthy range and in 2021 a systematic review of 12 studies trialling Withania extracts in healthy people found no serious health concerns.

CMA emphasise the importance of information within the TGA safety advisory of not purchasing overseas herbal products that do not contain an ‘AUST L’ or ‘AUST R’ number on the label. Overseas products are not subject to the same strict manufacturing standards and regulatory expectations as Australian ‘AUST L and AUST R’ products.

CMA recommends always reading the label and directions for use and not exceeding the recommended dose of herbal medicines. Anyone experiencing unusual symptoms to any medication should consult their healthcare professional and report the issue to the company selling the product.

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