IN BRIEF
- Andrographis, a common 'natural' cold and flu remedy, is under scrutiny after being linked to life-threatening allergic reactions.
- Experts say several factors are driving more Australians to self-prescribe potentially risky supplements.
Andrographis, a herbal ingredient commonly found in cold and flu supplements, is under renewed scrutiny after Australia's medicines regulator linked it to life-threatening allergic reactions.
The Therapeutic Goods Administration (TGA) has called for the ingredient to be removed from its list of permitted low-risk substances following ongoing reports of severe reactions, including anaphylaxis.
The decision has sparked broader concerns about complementary medicines, which around half of Australia's population is estimated to be using.
Joanna Harnett, associate professor of complementary medicines at the University of Sydney's School of Pharmacy, labelled the allergic reactions "very concerning and clinically relevant", and called for action to prevent further harm.
She told SBS News that while there is some evidence supporting the product's claims, it has been scrutinised under a lower-risk framework than its pharmaceutical counterparts.
Since 2005, the TGA has received more than 1,300 reports of adverse reactions linked to medicines containing the herb, including 287 cases of anaphylaxis and one reported death.
Despite safety warnings introduced in 2019 and strengthened labelling in 2024, regulators say there has been no meaningful reduction in the number of anaphylaxis cases reported.
Health authorities have warned reactions to the ingredient can be rapid and unpredictable, often occurring within 30 minutes, even in people with no history of allergies, and sometimes after previous uneventful use.
Used in a range of over-the-counter products widely available in pharmacies, supermarkets and health food stores without a prescription, raising broader concerns about the growing trend of self-medicating with so-called "natural" products.
The regulator is now seeking feedback from stakeholders as it considers whether the ingredient should remain available for self-selection.
Distrust of pharma — and a shift toward self-directed health
Royal Australian College of General Practitioners spokesperson Magdalena Simonis suggested that the popularity of andrographis could signal a broader shift in how Australians approach their health, with more Australians turning to supplements and "natural" remedies, often without seeking the appropriate advice.
She warned that attitudes toward pharmaceuticals and conventional treatments have become increasingly cautious in recent years.
Harnett said that at any point in time, 50 per cent of the general population was using some complementary medicine product.
"There are some concerning behaviours that have been largely fed by misinformation and overinflation of health claims on social media," Harnett said.
Simonis told SBS News that mistrust driven by uncertainty, misinformation, and shifting perceptions of risk has translated into a growing appetite for treatments perceived as more "natural", even where evidence of safety or effectiveness is limited.
"When people buy what they consider natural products that don't require a practitioner to prescribe, the assumption is that if it's available, then it must be safe, and the bottle says it does a certain thing so they expect it to.
"But anaphylaxis is a life-threatening condition. The fact that we have had deaths associated with andrographis is very significant," Magdelena said.
Cost pressures and access to care
Cost and access to healthcare could also be shaping how people manage their health.
Australian Bureau of Statistics data from November indicated that roughly one in seven Australians delayed or avoided seeing a GP due to cost, even as figures fluctuate year to year.
While bulk-billing rates have remained relatively stagnant, sitting at around 77.6 per cent, average out-of-pocket costs for a GP visit have risen beyond $50.
At the same time, the number of GP services has declined, with tens of thousands fewer consultations taking place each day compared to previous years.
That's sparked warnings that these pressures may be contributing to a rise in self-directed care, including the use of over-the-counter supplements and herbal products.
"Patients do not always volunteer information about the natural herbs and supplements they are taking, and sometimes they don't know what the active ingredients are, so they don’t think it is necessary to discuss this with their doctor," Simonis said.
"People are trying to self-help with over-the-counter products that may well contain products with ingredients that are not helpful or good for them."
Cultural traditions and the role of herbal medicine
For many Australians, particularly those from culturally diverse backgrounds, herbal medicine is not simply a trend but part of long-standing health practices.
Andrographis has been used in traditional Indian and Chinese medicine for centuries to treat conditions including colds, flu and inflammation.
Harnett said that while authentic traditional formulations can play an important role in holistic health, when administered by accredited traditional medicine practitioners, they may intersect differently with Australia's regulatory system, where products are often repackaged and marketed for mass consumption.
"The current concerns around andrographis paniculata have arisen largely in the context of its increasing popularity and widespread self‑selection, rather than use within traditional systems," she said.
Jon Wardle, director of the National Centre for Naturopathic Medicine at Southern Cross University, said the context in which these remedies are used, including dosage, formulation quality and practitioner guidance, can differ significantly from how they are consumed in self-prescribed over-the-counter products.
"A lot of people are not aware of the complexity of a lot of natural products …. People might think that natural equals simple, but these things are actually quite powerful pharmacological agents in their own right.
"It would be sad to see this herbal medicine go, though it does need more safeguards around it because they’re only safe if they’re used properly," Wardle said.
Bridging a gap between access and understanding
For regulators, the common use of andrographis highlights the broader challenge of products that are easy to access, but not always well understood.
"Andrographis' efficacy in supporting viral conditions is actually very tenuous, it is not supported by rigorous evidence because, in fact, there is not rigorous evidence," Simonis said.
"Instead, people turn to social media where specific algorithms support certain products being marketed in a specific way. Natural does not always equate to safe."
A spokesperson from the TGA told SBS News that patients should consult with their GPs about any complementary medicines for appropriate advice based on their individual clinical circumstances.
"Consumers should be educated about the signs of anaphylaxis and what to do if an allergic reaction occurs," the TGA spokesperson said.
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