Australia removes andrographis from ingredient list — ABC News Australia
Australia’s Therapeutic Goods Administration (TGA) is removing the plant Andrographis paniculata, or andrographis, from the list of ingredients permitted in medicines considered low risk for consumers. The decision concerns, in particular, certain over-the-counter cold and flu supplements sold in pharmacies and health food stores. This was reported by ABC News Australia.
The TGA said that delaying this step could create an imminent or serious risk of harm to consumers. Previously, the regulator required companies to place warnings on the packaging of products containing andrographis.
Reports of adverse reactions
The TGA received 1,468 reports of adverse reactions concerning 90 medicines containing andrographis. The reported reactions include anaphylaxis, nervous and immune system disorders, as well as urticaria. A report of a death was also received in June 2024.
The regulator plans to recommend voluntary measures to companies, which may include recalling medicines containing andrographis, working with manufacturers to cease production, and cancelling the inclusion of products in the Australian Register of Therapeutic Goods. If registration holders do not take timely voluntary action, from mid-October the TGA will assess the need for a mandatory recall or cancellation of the products’ inclusion in the register.
More current news is available on the UA.News Telegram channel Telegram.
Reaction from the company and specialists
BioCeuticals, which sells the ArmaForce and BioCeuticals Clinical Immune Force products containing andrographis, said it had stopped producing stock for supply. The company said it was engaging with the TGA regarding further steps, including the possible voluntary removal of the products from the market.
Professor of immunology and allergy at Western Sydney University Connie Katelaris, who studied andrographis and called for access to it to be restricted, welcomed the regulator’s decision. According to her, she and her colleagues had seen several cases of anaphylaxis in people who took such products in the hope of boosting immunity or easing respiratory infections.
The TGA advised consumers to reconsider the use of products containing andrographis because of the unpredictable and potentially fatal risk of anaphylaxis. At the same time, andrographis may continue to be used in registered medicines, which the TGA assesses for safety, quality and efficacy.
