Australia's Therapeutic Goods Administration (TGA) has issued a safety alert highlighting reports of liver injury associated with herbal preparations containing Withania somnifera (Ashwagandha). The regulator noted that cases continue to be reported both in Australia and internationally, prompting renewed attention to the safety profile of the widely used herbal ingredient. According to the TGA, Ashwagandha-containing products are readily available to consumers without the need for consultation with a healthcare professional. While most users tolerate the ingredient without significant adverse effects, the agency has identified rare cases of liver injury, including international reports of liver failure, liver transplantation, and fatalities in individuals with acute-on-chronic liver failure. No fatalities or liver transplant cases linked to Ashwagandha have been reported in Australia to date. The TGA advises consumers and healthcare professionals to remain vigilant for symptoms of liver injury, particularly when using products containing Withania somnifera. The safety alert underscores the importance of monitoring adverse events associated with herbal medicines and reporting suspected cases to support ongoing safety assessments. Manufacturers and sponsors of complementary medicines containing Ashwagandha should review the TGA communication and consider its implications for product safety monitoring and consumer information.
Consult
