Australia’s medicine regulator is considering a ban on the over-the-counter sale of a herbal ingredient found in popular cold and flu supplements, like Armaforce.
The Therapeutic Goods Administration (TGA) launched a review into andrographis paniculataafter a death linked to a supplement containing the herb.
The cause of death was anaphylaxis, a severe and life-threatening allergic reaction.
Here’s what you need to know.
Background
Andrographis paniculata is a herb found in around 80 products currently registered with the TGA.
It is marketed for immune support and relief of common cold and flu symptoms like congestion and fatigue.
Under Australian regulations, products like these are called “listed
medicines.”
They can only contain ingredients classified as low-risk, meaning the TGA has assessed them as safe enough to take without a prescription.
TGA review
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The TGA launched a new review into andrographis in July 2024, one month after a man had a fatal anaphylactic reaction in Queensland.
Since 2005, the regulator has received more than 1,200 reports of adverse reactions related to medicines containing the herb, including 287 incidents of anaphylaxis.
The number of incidents has remained consistent in recent years, even after the addition of warning labels in 2019.
The review concluded that stronger label warnings were inadequate, with the TGA noting: “For consumers experiencing these symptoms, the label warning becomes irrelevant.”
It also noted that more than 80% of the reported incidents were for medicines containing both andrographis and echinacea – another common herbal ingredient also linked to allergic reactions.
The TGA is now proposing to remove andrographis from the approved list for low-risk listed medicines. If the proposal goes ahead, products containing the ingredient could no longer be sold as over-the-counter supplements.
Response
Professor Mark Morgan from the RACGP welcomed the move to remove andrographis from the list of permitted ingredients, saying: “The evidence of benefits for andrographis to relieve cold and flu symptoms is limited”.
In the meantime, the TGA has updated its safety advice, warning consumers of the risk of anaphylaxis.
The regulator will consult with stakeholders before it makes a final decision.
