A common ingredient found in cold and flu supplements sold across Australia is under renewed scrutiny, after reports it can cause severe allergic reactions, including life-threatening anaphylaxis.
The herb, Andrographis paniculata, is found in popular products sold at pharmacies and supermarkets and is marketed to help relieve cold and flu symptoms and support immunity. But Australia’s medicines regulator says there are serious risks many people may not be aware of.
Reactions can be sudden and severe
According to the Therapeutic Goods Administration (TGA), reactions to andrographis can be “rapid and unpredictable”.
Some people have experienced severe allergic responses even after taking the herb previously without any issues, while others reacted the first time they used it.
Since 2005, the TGA has received 1368 reports of adverse reactions linked to medicines containing andrographis, including 287 cases of anaphylaxis, a serious and potentially fatal allergic reaction that requires immediate medical attention.
Warnings have increased but cases continue
Concerns about andrographis aren’t new.
The TGA has issues a warning about the herb, Andrographis paniculata, found in popular cold and flu products sold at pharmacies and supermarkets. Image: Getty
The TGA first issued a public alert in 2015 after a safety review found the herb could cause serious allergic reactions. In 2019, products containing andrographis were required to carry warning labels about this risk.
In August 2024, supplement manufacturer BioCeuticals updated the label on its popular cold and flu product ArmaForce to include a warning about anaphylaxis.
Despite these measures, there have been continued reports allergic reactions. In June 2024, the TGA was notified of a death linked to anaphylaxis after taking a product containing andrographis. There has also been a reported case of drug-induced liver injury.
Exactly why some people react so severely isn’t fully understood, and many of those affected had no prior history of allergies or asthma.
What the regulator is looking at now
The TGA is now reviewing whether andrographis should continue to be classified as a “low-risk” ingredient in listed medicines.
These are products that can be sold without a prescription, including many herbal supplements.
“Current risk mitigation strategies, including stronger label warnings, have not reduced the risk of anaphylaxis,” the TGA said in its report, concluding that labelling alone may not be enough to protect consumers.
A public consultation is now underway, with input sought from health professionals, industry groups and consumers before any final decision is made.
What to know before taking supplements
While supplements can feel like an easy addition to your routine, especially during cold and flu season, this is a reminder that even commonly used ingredients can carry risks.
If you notice symptoms of an allergic reaction after taking a supplement – such as swelling, difficulty breathing, hives or dizziness – stop using the product and seek medical advice. In an emergency, call triple zero (000) immediately.
It’s also worth checking labels carefully and speaking with your GP before starting any new supplement, particularly if you’re pregnant, breastfeeding, have existing health conditions or are taking medication.
Health and Beauty Editor
Melody Teh
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