Eleven possible liver injury cases associated with the herbal preparation’s use have been reported to the TGA in recent years.
Earlier this month the Therapeutic Goods Administration released a safety alert regarding herbal preparations containing Withania somnifera, more commonly known as ashwagandha.
The TGA issued a safety advisory in 2024 that highlighted how medications and herbal supplements containing W. somnifera could cause liver injury in extremely rare cases.
Since then, the TGA has received an additional four adverse event reports involving potential liver injuries that have contained enough information to suggest that the injury may have been caused by medicines containing W. somnifera.
“However, in 2 cases, there were other ingredients linked to liver injury that may have contributed to the reported reactions. All resolved on discontinuation of the suspected medicine and none reported that hospitalisation was needed,” the TGA said in a statement.
Individuals taking medications or herbal supplements containing W. somnifera are advised to stop taking it and seek medical attention if they experience yellowing of the skin or eyes, dark urine, nausea, vomiting, unusual tiredness, stomach or abdominal pain, or a loss of appetite.
“Please be aware that sudden vomiting and/or diarrhoea after only one or two doses may not be liver damage, but rather an acute reaction that should resolve when the medicine is stopped. If this occurs, stop use and see a doctor for assessment,” the TGA advised.
“As a precaution, if you currently have or have had liver problems, you should avoid medicines and herbal supplements containing W. somnifera.”
Related
In a related medicines safety update written for health professionals, the TGA encouraged health professionals to report any suspected adverse events associated with herbal medicines.
“Timely and accurate reporting enhances our ability to detect emerging safety signals and take appropriate regulatory action to protect public health,” it said.
“In addition to cases reported in Australia, we are aware of possible liver injury cases associated with single ingredient W. somnifera medicines received by regulators in other countries, as reported to the World Health Organization Programme for International Drug Monitoring.
“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. We will continue to assess emerging evidence and determine on the weight of the evidence whether any regulatory action is necessary.”
W. somnifera is widely used in Ayurvedic and other traditional medicine systems. It is a permitted herbal ingredient in listed medicines in Australia, but certain products containing the preparation can be purchased without consulting a medical professional.
Elsewhere, the TGA have released a separate safety alert regarding GLP-1 RAs and rare but severe eye disorders.
While the alert does not mention whether any adverse events have been reported to the TGA, it highlighted the potential for dulaglutide, semaglutide, tirzepatide, and liraglutide to cause non-arteritic anterior ischaemic optic neuropathy, a condition that can cause permanent visual impairment.
Patients are advised to seek medical attention if they experience any changes in their vision after using these medications.
