TGA bans a common cold remedy ingredient over anaphylaxis risk

If you have ever reached for an OTC cold tablet during winter, there is a reasonable chance andrographis was in it. The TGA has now removed it from the list of permissible ingredients for new listed medicines — effective mid-October 2026 — after concluding that the risk of severe allergic reactions, including anaphylaxis, “cannot be managed well enough” under the self-regulation pathway that governs listed medicines.

This is a regulatory action that matters for anyone who picks up a herbal cold and flu product at the pharmacy and does not think to read the fine print.

What just happened — and why it matters

Andrographis paniculata is a traditional South Asian herb that entered the Australian OTC market in cold and flu tablet, capsule and liquid formulations. From 2005 through December 2025, the TGA received 1,368 adverse event reports linked to the ingredient. One person died in June 2024.

The nature of the anaphylaxis risk is what makes this particularly concerning. Anaphylaxis can occur within 30 minutes of use — and it can happen on first exposure, not just in people with a prior reaction to the ingredient. Someone who has taken the same product safely before is not protected from a severe reaction the next time.

That is different from the more predictable allergic picture most patients are familiar with, where repeated exposures escalate the reaction. With andrographis, the first time can be the worst time. That unpredictability is one reason the TGA concluded the risk could not be adequately managed within the self-regulation pathway that applies to listed medicines — a pathway that relies heavily on sponsor responsibility rather than pre-market clinical scrutiny.

What it means for what is already on shelves

Existing products are not immediately recalled. The TGA has not issued a mandatory recall notice; instead, it has encouraged sponsors to voluntarily withdraw affected products. That means andrographis-containing tablets may remain at pharmacies, health food stores, and supermarkets for some time.

This is the practical gap in the announcement. A regulatory ban on new products does nothing for the blister packs already in people’s bathroom cabinets.

If you have a cold and flu supplement at home, it is worth checking the ingredient list now, while you are well. The herb may be listed as Andrographis paniculata, andrographis, or Kalmegh. The TGA recommends disposal of any products containing it.

Both sides of this

There are people who will point out that 1,368 adverse events over 20 years, across a product used by millions of Australians, represents a small absolute risk. That is mathematically defensible and worth holding alongside the rest of the picture.

The rest of the picture is this: listed medicines occupy a regulatory space that does not require the same pre-market clinical evidence as registered medicines. They are permitted to carry a therapeutic claim — for example, “helps relieve cold and flu symptoms” — on the basis of the ingredient’s traditional use and a demonstrated safety profile. The premise is that the risk-benefit calculation at population scale favours easy access. When one fatal anaphylaxis and 1,368 adverse events accumulate over two decades, that premise is re-examined.

The TGA’s position is that the severity and unpredictability of anaphylaxis tips the balance. That is a reasonable clinical framing. Anaphylaxis is not a moderate allergic reaction. It is a life-threatening emergency that can be fatal within minutes without immediate adrenaline.

For most people who have taken andrographis products without incident, the risk feels abstract. For the person who experienced a first-exposure anaphylaxis after buying a $15 cold remedy at a pharmacy, it did not.

What this means for your next cold

The practical consequence is that a product many people have relied on will no longer be available. Its absence is not a supply issue — it is a safety decision.

For symptomatic cold management, options with clinical support that remain available include rest, adequate fluid intake, and paracetamol or ibuprofen for fever and pain. For patients with frequent respiratory infections, a GP review is more useful than rotating through OTC remedies. There is currently no evidence that any complementary medicine reduces the duration or severity of a common cold by a clinically meaningful margin. That does not mean supplements carry no value to the individuals who use them, but it is worth knowing where the evidence sits.

If you want to discuss complementary medicine use with your GP, the TGA action makes this a reasonable prompt. GPs are advised to proactively ask patients about complementary medicine use and to counsel on anaphylaxis risk — the advisory is directed at clinicians, but patients can initiate the same conversation.

For GPs

The newsGP advisory specifically recommends asking patients about past reactions to cold and flu supplements and counselling on allergy and anaphylaxis risk. Any patient reporting a past unexplained allergic reaction to a cold supplement — particularly involving urticaria, angioedema, throat tightness, or rapid haemodynamic change — warrants a targeted history and consideration of allergy testing.

Suspected adverse events should be reported to the TGA. Each report contributes to the post-market surveillance that drives exactly the kind of regulatory action announced this week.

Verdict: yes — check your medicine cabinet, dispose of any andrographis product, and ask your GP if you have had a past reaction to a cold and flu supplement.

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Sources cited

1. TGA acts on high-risk supplement ingredient — newsGP, 25 September 2026: https://www1.racgp.org.au/newsgp/clinical/tga-acts-on-high-risk-supplement-ingredient
2. TGA regulatory decision — andrographis paniculata, October 2026: https://www.tga.gov.au/news/regulatory-decision-notices/high-moderate-risk-changes-permissible-ingredients-andrographis-paniculata-2026