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A community safety advisory has been issued over the use of medicines containing ashwagandha which are commonly available for purchase as over-the-counter products in pharmacies and supermarkets.
The herb, scientifically known as Withania somnifera, has led to a string of people being hospitalised as of late over sudden and serious gastrointestinal problems.
The Therapeutic Goods Administration (TGA) said it had received reports from several consumers who encountered “adverse events” – side effects – including severe nausea, vomiting, and diarrhoea upon taking the herb, 16 of whom required hospitalisation.
Negative health reactions were immediately resolved in many of these cases after they stopped using the product, but the TGA said those hospitalised remained severe enough.
“In some reports, vomiting and diarrhoea occurred after a single dose and in others, it was initially mistaken for food poisoning,” the health notice read.
Additionally, the TGA received 12 reports of people having experienced liver problems after consuming herbal supplements or medicine containing Withania somnifera until February 5.
Four of these cases required hospitalisation.
While there is a relatively low risk of liver injury from ashwagandha consumption, multiple cases have been reported by medicinal regulators in other countries and have also been mentioned in scientific literature.
“This is a relatively new issue globally, and we are continuing to closely monitor emerging evidence,” the TGA said.
“If further substantiating evidence arises, regulatory actions will be considered. This could include warning statements on product labels or other changes to the requirements for ingredients permitted for use in listed medicines.”
Withania somnifera has long been used in traditional Ayurvedic medicine and expansively as a medicinal herb across the world.
The newly discovered gastrointestinal side effects – and extremely rare liver risks – associated with the usage of the herb have sparked a safety investigation by the therapeutic regulator.
There are currently 320 medicines listed in the Australian Register of Therapeutic Goods (ARTG) that contain Withania somnifera. These do not, however, account for medicines purchased from overseas suppliers online.
Anyone who experiences symptoms of dark urine, nausea, vomiting, unusual fatigue, stomach or abdominal pain, appetite loss, and yellowing of the skin or eyes after consuming ashwagandha is urged to immediately discontinue using the product and seek medical advice.
People who currently have a history of liver problems should avoid usage as a precautionary measure.
“Sudden vomiting and/or diarrhoea after only one or 2 doses may not be liver damage, but rather an acute reaction that should resolve when the medicine is stopped,” the TGA advised.
“If this occurs, stop use and see a doctor for assessment.”
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