Andrographis cold supplement banned by TGA after fatal anaphylaxis

Australia’s Therapeutic Goods Administration has moved to remove Andrographis paniculata from over-the-counter cold and flu supplements — a decision that follows twenty years of adverse event accumulation, one fatality, and the conclusion that warning labels are no longer sufficient.

This is not precautionary speculation. The regulator documented 1,368 adverse event reports for Andrographis-containing medicines by 31 December 2025. Among those: anaphylaxis, severe allergic reactions, and a fatal case in June 2024. The TGA had required label warnings since 2019 and issued a dedicated safety alert in 2024. Cases continued regardless.

The TGA’s stated position is exact: “Listed medicines are generally lower-risk products. We have decided that the risk of severe allergic reactions, including anaphylaxis associated with Andrographis, cannot be managed well enough under this pathway.”

The listed medicines pathway — where most pharmacy-shelf herbal products sit — does not require pre-market proof of efficacy or individualised safety assessment. That lower bar is part of its design. Which is why this decision carries weight: even by a pathway intended for lower-risk products, the Andrographis safety signal became untenable.

What’s happening on shelves

Andrographis will not disappear from shelves overnight. Existing listed medicines are not subject to immediate mandatory recall. Sponsors have been encouraged to voluntarily recall products before mid-October 2026. In practical terms, a patient may still be holding — or actively purchasing — a product that is weeks from formal regulatory removal.

The herb appears across multiple product names and is frequently combined with echinacea, zinc, or vitamin C in cold and flu formulations. Patients often do not recognise the ingredient. The term to look for is Andrographis paniculata — sometimes marketed under the common name ‘king of bitters.’ It is worth naming it by that name in conversation, because a patient scanning a label for “Andrographis” may not recognise an unfamiliar Latin species name on first glance.

The product can theoretically remain accessible through the registered medicines pathway, which requires individual safety and efficacy assessment before approval. Whether any sponsor pursues that route commercially remains uncertain.

Both-and: a long-used remedy meets a genuine safety signal

Andrographis has been used in Ayurvedic and traditional Chinese medicine for centuries. In clinical trials it has shown modest evidence of benefit for upper respiratory tract infections — real enough that it earned a place in ARTG-listed formulations for years and remained on shelves through multiple rounds of regulatory review.

That background matters for conversations with patients who have used it without incident for a decade. Their experience of safety is not wrong — most people who took these products did not experience anaphylaxis. The clinical problem is that the reaction profile is unpredictable: reactions can occur on first exposure or after years of prior uneventful use, typically within 30 minutes. There is no reliable clinical predictor of individual risk.

The both-and framing here is: the product showed some evidence of benefit, the safety signal was real, and the regulator’s threshold for over-the-counter access was eventually reached. Those two facts coexist. The TGA is not saying Andrographis is pharmacologically inert; it is saying the risk cannot be adequately managed outside a supervised clinical setting.

That framing also matters for patients who may perceive this as the regulator overreacting against a traditional remedy. The 2024 fatality is the data point that makes this legible as a proportionate response.

2 cents

The operational question this week is whether to raise it proactively.

A meaningful proportion of patients using Andrographis-containing products do so for self-managed respiratory symptoms — the kind of illness they do not mention at a consultation. They buy it at a pharmacy, feel better, assume it is safe, and repeat. They will not necessarily see the TGA advisory or connect it to a product they have been using for years.

If you have a patient who regularly reaches for herbal cold and flu remedies, it is worth naming Andrographis specifically. The conversation is short: “One ingredient that’s just been removed from over-the-counter products is Andrographis — check the label on anything you have at home and stop using it if it is there.” That is a low-effort clinical touchpoint with meaningful stakes.

For patients who ask about anaphylaxis risk from supplements generally: the mechanism of Andrographis-triggered anaphylaxis is not well characterised, which is part of why the TGA concluded it could not be managed with label-based warnings. The reaction can occur without prior sensitisation on record, which makes consumer self-assessment unreliable.

The fatality was one case. Anaphylaxis at home, in someone without an adrenaline auto-injector and no prior awareness of risk, does not always end well.

Verdict: yes — worth raising proactively with patients who use herbal cold and flu products.

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Sources cited

1. TGA acts on high-risk supplement ingredient — newsGP / RACGP