TGA acts on high-risk supplement ingredient

Australia’s medicines regulator has taken action to remove a high-risk ingredient from over-the-counter herbal cold and flu supplements, after ongoing reports of severe allergic reaction.
 
Andrographis paniculata (Andrographis) is found in a range of herbal medicines, and as a listed medicine, it was able to be purchased at pharmacies, supermarkets and health food stores without a prescription.
 
However, the Therapeutic Goods Administration (TGA) announced this week that new medicines containing Andrographis paniculata (Andrographis) are no longer eligible to be listed in the Australian Register of Therapeutic Goods (ARTG).
 
‘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 TGA stated.
 
‘We have continued to receive reports of anaphylaxis linked to medicines containing Andrographis. This includes a fatal case reported in June 2024.’
 
Delaying implementation of this change would likely pose an imminent or serious risk of injury to consumers, the TGA warned.
 
The TGA began receiving anaphylaxis reports for Andrographis-containing medicines in 2005, and to 31 December 2025, the regulator had received 1368 adverse event reports.
 
Medicines already listed will not be removed immediately, so patients may still have access, but supplement sponsors are ‘strongly encouraged’ to take ‘timely voluntary action’, such as consumer recalls, before the TGA takes regulatory action from mid-October 2026.
 
The TGA explained that the removal of Andrographis does not mean removing consumers’ access to Andrographis altogether. Instead, it will ensure that medicines containing Andrographis are regulated in a way that better matches its safety risks.
 
‘This can be done via the registered medicines pathway,’ the TGA said.
 
‘Under this pathway, individual medicines are assessed by the TGA for safety, quality and effectiveness before they are registered in the ARTG. Registered medicines may be accompanied with consumer medicine information and product information for consumers and health professionals.’
 
Since 2019, medicines containing Andrographis have been required to carry a label warning about the risk of allergic reactions. Despite these warnings, reports of anaphylaxis linked to Andrographis have continued.
 
In 2024, the TGA also published a safety alert and one medicine sponsor added a stronger and more prominent warning label as a further safety measure, yet this had not led to a ‘meaningful reduction’ in anaphylaxis cases.
 
RACGP Specific Interests Integrative Medicine Chair, Dr Tamara Nation, told newsGP having ‘higher-level standards by the TGA is in the public interest’.
 
‘In the future it does not mean that Australian consumers can no longer access Andrographis,’ she said.
 
‘However, it does mean that there will be more stringent standards for Andrographis containing products and that individual products containing Andrographis will need to be registered under the registered medicines pathway.’
 
The TGA decision comes after the regulator flagged its intentions earlier this year and undertook targeted consultation.
 
Dr Nation, who has extended skills in integrative medicine, said GPs will should be aware of the changes and advise patients accordingly.
 
‘GPs need to understand that Andrographis is no longer listed as a “permissible ingredient” by the TGA [and] need to advise patients how to dispose of supplements containing Andrographis,’ he said.
 
‘GPs need to be able to explain to patients currently taking Andrographis containing products to be aware of the risk of allergy and anaphylaxis.’
 
This means taking proactive steps, added Dr Nation.
 
‘Many patients do not voluntarily discuss complementary medicine use,’ she said.
 
‘It is important to remove stigma and bias from our conversations with patients around complementary medicine use.
 
‘This will facilitate open discussions and enable us to inform patients about important changes to standards and enable us to better support out patients’ healthcare and choices.’
 
Health professionals are also being urged by the TGA to:
 

• advise patients based on their individual circumstances
• be aware that reactions may happen on first use or after previous use without problems
• tell patients that reactions often happen within 30 minutes
• report suspected problems with medicines or vaccines to the TGA.

anaphylaxis Andrographis herbal supplements medicine safety medicines regulation TGA Therapeutic Goods Administration