The Therapeutic Goods Administration (TGA) has identified a significant health risk associated with a herb commonly found in cold and flu supplements, linking it to the potential for severe anaphylactic reactions.<\/p>\n
Following a comprehensive safety assessment, the TGA determined that enhancing warning labels on products containing Andrographis paniculata<\/em> would not be sufficient to mitigate the associated risks. Consequently, the agency plans to engage with stakeholders regarding the removal of this herb from the list of low-risk ingredients.<\/p>\n The herb Andrographis paniculata<\/em>, present in around 84 different listed medications aimed at alleviating cold and flu symptoms and enhancing immunity, has now been recognized for its potential to cause life-threatening allergic reactions. Listed medicines are classified as low-risk and may only include ingredients deemed non-hazardous, allowing them to be sold in various retail settings, including pharmacies.<\/p>\n In its safety review, the TGA noted that users of supplements containing Andrographis paniculata<\/em> have reported unpredictable allergic responses, regardless of whether they were first-time users or had prior experience with the product. Since 2005, the TGA has documented 1,368 adverse reaction reports linked to this herb, with 287 of those instances involving anaphylaxis. The report indicated that the ongoing high volume of reports since 2019 suggests that Andrographis<\/em> is associated with a risk of severe anaphylactic reactions, which contradicts its classification as a low-risk ingredient.<\/p>\n Professor Connie Katelaris AM, an expert in immunology and allergy from Western Sydney University, has been vocal in her warnings to the TGA about the dangers associated with the herb, arguing that the risks outweigh any potential benefits. \u201cThis substance has caused harm and even deaths worldwide,\u201d she remarked. \u201cData from various countries confirm adverse reactions to this product. I fully support the TGA’s findings that it is unsafe. Despite warnings and labels, these measures have proven ineffective in preventing reactions.\u201d<\/p>\n In 2019, a label warning was introduced for products containing Andrographis<\/em>, indicating a potential for allergic reactions. More recently, in August 2024, BioCeuticals, a manufacturer of ArmaForce\u2014one of the widely used cold and flu supplements featuring the herb\u2014updated its labeling to include a warning about the risk of anaphylaxis.<\/p>\n The TGA’s review highlighted that the number of reports of anaphylaxis related to this medication in 2025 remains consistent with the high levels recorded in 2022 and 2023, even prior to the introduction of the enhanced warning in 2024. The regulator concluded that merely strengthening label warnings would not sufficiently address the safety concerns. \u201cFor patients experiencing these symptoms, warning labels become irrelevant,\u201d the report stated, adding that such warnings do not assist individuals who lack immediate access to emergency treatment, such as adrenaline.<\/p>\n Carmen Wells, who suffered an adverse reaction after using a supplement containing Andrographis<\/em>, described her experience of developing yellowing of the skin and eyes after treatment. Initially diagnosed with drug-induced liver injury, her condition was later revised to drug-induced autoimmune hepatitis. \u201cEven after six years, I continue to manage my health, which requires regular blood tests,\u201d Wells commented, expressing relief at the TGA’s findings. \u201cIt aligns with what many have been saying, and I am pleased that this issue has finally been recognized through research, although I am frustrated by the delay in releasing this data.\u201d<\/p>\n The TGA initiated its safety review in July 2024, following a report of a fatal anaphylactic incident in Queensland. Professor Katelaris expressed her frustration with the duration of the review process, pointing out the clear accumulation of data indicating the herb’s dangers. \u201cThe TGA’s own statements acknowledge that their previous warnings have been inadequate in preventing harm,\u201d she stated. \u201cIt is concerning that this product remains available to the public.\u201d<\/p>\n Moving forward, the TGA plans to consult with health professionals, manufacturers, and consumer advocacy groups about its proposal to remove Andrographis<\/em> from the list of low-risk ingredients. A spokesperson for the TGA confirmed that the consultation period will conclude on April 30, after which the agency will review the feedback received. \u201cIf the TGA determines to remove Andrographis<\/em> from the Permissible Ingredients Determination, it will no longer be permitted for use in low-risk listed medicine products,\u201d the spokesperson explained. However, the herb will still be available for use in prescription and registered non-prescription medications, with no current plans to restrict its use in those categories.<\/p>\n Professor Katelaris criticized the TGA for engaging in a consultation process, deeming it unnecessary given the existing evidence. \u201cThe TGA’s expert committees have already met and acknowledged the safety concerns months ago. I fail to see the benefit of further stakeholder input at this stage. The TGA should take decisive action,\u201d she asserted.<\/p>\n","protected":false},"excerpt":{"rendered":" The Therapeutic Goods Administration (TGA) has identified a significant health risk associated with a herb commonly found in cold and flu supplements, linking it to the potential for severe anaphylactic reactions. Following a comprehensive safety assessment, the TGA determined that enhancing warning labels on products containing Andrographis paniculata would not be sufficient to mitigate the […]<\/p>\n","protected":false},"author":2,"featured_media":6175,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[1495,1493,43,1494],"tags":[],"class_list":["post-6176","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-au-allergies","category-au-alternative-medicine","category-australia","category-au-coughs-and-colds"],"yoast_head":"\n