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A warning has been issued over a popular herbal supplement sold in supermarkets and pharmacies after several Australians developed serious liver injuries and others were hospitalised with sudden vomiting and diarrhoea.
The herb Withania somnifera, commonly known as Ashwagandha or winter cherry, is commonly used to reduce anxiety, improve sleep and build strength.
It is an ingredient in about 320 medicines listed by the Australian Register of Therapeutic Goods and is sold in supermarkets, health food stores and pharmacies without a prescription or the advice of a health professional.
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The Therapeutic Goods Administration is investigating its use after dozens of Australians reported gastrointestinal problems after taking the herb.
Users reported sudden and severe nausea, vomiting and diarrhoea – sometimes after just a single dose.
A number of people initially mistook the symptoms for food poisoning but their symptoms resolved after they stopped taking the medicine.
Sixteen people became so ill that they had to be hospitalised.
There have also been 12 reports of Australians who developed liver problems after taking Withania somnifera.
Of these, the TGA found sufficient evidence to suggest that seven cases were caused by the herb and in four no other ingredients were in the supplements that could have contributed to the liver injury.
Most patients recovered after they stopped taking the medicinal herb, but four had to be treated in hospital.
The TGA's investigation concluded that there is a "very rare" risk of liver injury from taking Withania somnifera.
The health body advised anyone with a history of liver problems to avoid taking the herb.
Others should stop immediately if they experience symptoms, which include yellowing of the skin or eyes, dark urine, nausea, vomiting, unusual tiredness, abdominal pain and loss of appetite.
"This is a relatively new issue globally, and we are continuing to closely monitor emerging evidence," the TGA said in a statement about its investigation.
"If further substantiating evidence arises, regulatory actions will be considered."
These could include adding warning labels on products containing Withania somnifera or additional restrictions around its sale.
