A common herb used in dozens of popular cold and flu supplements in Australia has been officially linked to life-threatening anaphylaxis, prompting a regulatory push to remove it from the category of low-risk medicines.
The Therapeutic Goods Administration (TGA) completed a safety review of Andrographis paniculata, an ingredient found in approximately 84 listed medicines marketed to boost immunity and relieve respiratory symptoms. Under current Australian regulations, listed medicines are classified as low-risk and can be purchased over the counter at pharmacies and retail outlets without a prescription.
The TGA’s findings reveal that reactions to the herb are “unpredictable,” occurring regardless of whether a patient is using the product for the first time or has a history of safe apply. Since 2005, the regulator has received 1,368 reports of adverse reactions associated with medicines containing Andrographis, including 287 documented incidents of anaphylaxis.
The surge in reports has led regulators to conclude that the herb’s safety profile is inconsistent with the low-risk regulatory framework. “The sustained high reporting pattern since 2019 indicates that Andrographis is associated with risk of life-threatening anaphylaxis,” the TGA report stated, adding that current risk mitigation efforts, such as strengthened label warnings, have failed to reduce the danger to a level suitable for listed medicines.
A failure of warning labels
For years, the industry attempted to manage the Andrographis paniculata anaphylaxis risk through labeling. In 2019, products were required to warn consumers that the ingredient may cause allergic reactions. By August 2024, BioCeuticals—the manufacturer of ArmaForce, one of the most widely used supplements containing the herb—updated its label to specifically mention the risk of anaphylaxis.
ArmaForce is one of dozens of products containing the herb Andrographis paniculata. (ABC News: Jerry Rickard)
However, the TGA’s review found that the number of anaphylaxis reports in 2025 remained consistent with the high numbers seen in 2022 and 2023, prior to the updated warnings. The regulator concluded that for a patient experiencing a sudden, severe allergic reaction, a label is irrelevant—particularly for those without immediate access to emergency treatment like adrenaline (epinephrine).
Professor Connie Katelaris AM, a specialist in immunology and allergy at Western Sydney University, has long argued that the risks of the herb outweigh its perceived benefits. “This stuff causes harm, it has caused death and What we have is a global thing,” Professor Katelaris said, noting that adverse responses have been documented in multiple countries.
Connie Katelaris says products containing Andrographis paniculata should be removed from the shelves of pharmacies. (ABC News: Jerry Rickard)
Long-term health complications
While anaphylaxis is the most immediate threat, some patients have suffered chronic, debilitating health issues. Carmen Wells, who used an Andrographis supplement to treat a cold in 2019, noticed her skin and eyes turning yellow shortly after use.
Ms. Wells was initially diagnosed with drug-induced liver injury, a diagnosis later revised to drug-induced autoimmune hepatitis. Six years later, she continues to manage her health through regular blood testing. “It’s always in the background, it’s always something I have to think about,” she said.
Carmen Wells’s doctor initially diagnosed her with a drug-induced liver injury after taking a cold and flu supplement containing the herb. (Supplied: Carmen Wells)
Regulatory timeline and next steps
The TGA’s current safety review was triggered in July 2024, following a report of a fatal anaphylactic reaction in Queensland the previous month. The regulator is now proposing to remove Andrographis paniculata from the “Permissible Ingredients Determination” for low-risk listed medicines.
If the proposal is finalized, the herb will no longer be available in over-the-counter listed products, though the TGA noted it may still be used in prescription and registered non-prescription medicines, which are subject to stricter oversight.
| Date/Period | Event |
|---|---|
| 2005–Present | TGA receives 1,368 adverse reports, including 287 anaphylaxis cases. |
| June 2024 | Report of a fatal anaphylactic reaction in Queensland. |
| July 2024 | TGA officially launches safety review of Andrographis paniculata. |
| August 2024 | BioCeuticals updates ArmaForce labels to warn of anaphylaxis. |
| April 30, 2025 | Consultation period for removal from low-risk list closes. |
The decision to engage in a consultation process has been met with criticism from health experts and patients. Professor Katelaris called the process “completely unnecessary,” arguing that the data is clear-cut and the TGA should simply remove the products from pharmacy shelves immediately.
In response, a TGA spokesperson stated that legislation requires “meaningful consultation with persons who may be affected,” including sponsors and markets, to understand all risks associated with the regulatory decision.
BioCeuticals stated that its products meet “current TGA regulatory requirements” and that the company is reviewing the consultation and will accept necessary steps following the outcome.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult a healthcare professional before starting or stopping any supplement or medication.
The TGA is currently reviewing responses from the consultation period that closed on April 30. A final determination on whether Andrographis paniculata will be removed from the low-risk listed medicines category is expected following this review.
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