The Therapeutic Goods Administration (TGA) has initiated a consultation process regarding the potential removal of Andrographis paniculata, a low-risk ingredient, from the list of permitted substances in listed medicines. This decision comes in light of several reports of anaphylaxis, a severe and potentially life-threatening allergic reaction, linked to the use of Andrographis. The TGA's action is a proactive measure to ensure public safety, as anaphylaxis can occur rapidly and unpredictably, even in individuals with no prior history of allergies.
Andrographis is commonly found in herbal medicines designed to alleviate cold and flu symptoms, readily available over the counter at various retail outlets. The proposed removal is a critical step to address the serious health risks associated with this ingredient. Anaphylaxis, a rapid and severe allergic reaction, can manifest within 30 minutes of ingestion and often necessitates immediate medical attention.
The TGA's invitation for stakeholders, including consumer associations, health professionals, and industry representatives, to provide feedback on the proposed removal is a transparent and inclusive approach. This consultation ensures that all perspectives are considered before a final decision is made. The TGA has also released an updated safety review and supplementary report, analyzing adverse event data up to 31 December 2025, to provide comprehensive information to the public.
Consumers are urged to refer to the TGA's webpage for detailed safety information before considering the use of Andrographis. This proactive approach by the TGA demonstrates a commitment to public health and safety, ensuring that any potential risks associated with medical ingredients are thoroughly evaluated and addressed.
