TGA Withdraws Popular Cold and Flu Ingredient From Australian Market
核心洞察
Australia's TGA will remove Andrographis paniculata from the Therapeutic Goods (Permissible Ingredients) Determination effective 17 September 2026, following 287 anaphylaxis (搜索) reports since 2005.
The safety review logged 1,368 adverse event reports up to 31 December 2025, including ageusia (搜索) and dysgeusia (搜索), and found reactions unpredictable and unrelated to prior allergy history.
Around 70 to 80 listed cold, flu and immune-support medicines contain the herb, including BioCeuticals (搜索)' ArmaForce (搜索) and Swisse (搜索)'s Ultiboost Immune Action (搜索), with voluntary withdrawal urged before compulsory recalls from mid-October 2026.
The Therapeutic Goods Administration (搜索) will remove the herbal ingredient Andrographis paniculata from the Therapeutic Goods (Permissible Ingredients) Determination, effective 17 September 2026, after years of reports linking it to severe and sometimes fatal allergic reactions. A TGA safety review recorded 287 reports of anaphylaxis (搜索) associated with Andrographis-containing medicines since 2005, including a fatal case reported in June 2024. Earlier measures, including a mandated warning label in 2019 and a 2024 safety alert with a stronger sponsor warning label, did not produce a meaningful reduction in reports.
The review found reactions to Andrographis are unpredictable, can occur on first use, and mostly affected people with no prior history of allergy or asthma, which undermines strategies relying on patient self-screening. The TGA logged 1,368 adverse event reports up to 31 December 2025 for Andrographis-containing medicines, including ageusia (搜索) and dysgeusia (搜索). Around 70 listed medicines contain the herb, most marketed for cold, flu and immune support, including BioCeuticals (搜索)' ArmaForce (搜索), Clinical Immune Force (搜索) and Swisse (搜索)'s Ultiboost Immune Action (搜索). More than 80% of reported adverse events involved Andrographis combined with Echinacea species.
From 17 September 2026, new medicines containing Andrographis will no longer be eligible for listing on the Australian Register of Therapeutic Goods. Already-listed products will not be pulled immediately; the TGA has strongly encouraged sponsors to voluntarily cancel their ARTG entries, cease manufacturing and release of stock, or conduct a consumer-level recall, with compulsory recalls or cancellations to begin from mid-October 2026 if sponsors do not act. BioCeuticals (搜索) said it has ceased releasing stock and is engaging with the TGA on voluntary withdrawal. The herb is not banned outright, and any product containing it will require individual TGA assessment through the registered medicines pathway. Pharmacists have been told reactions often occur within 30 minutes of taking the product, and that viral infections, anti-inflammatory medicines such as ibuprofen, alcohol use and exercise around the time of exposure may increase risk or severity.
Source: Australian Pharmacist