Australian medicines regulator recalls andrographis-based cold remedies

Summarised from 2 outlets · Updated 12 Oct, 08:24 · Archive

Australia's Therapeutic Goods Administration has recalled cold and flu medicines containing andrographis after reports of severe allergic reactions and one death.

Cold and flu medicines containing andrographis have been recalled across Australia after the Therapeutic Goods Administration identified a sustained increase in severe allergic reactions linked to the ingredient. The TGA said that andrographis, used in Chinese and Indian traditional medicine to treat influenza and the common cold, will no longer be listed as a low-risk product for consumers.

Following a significant rise in anaphylaxis reports in 2019, the TGA has continued to receive a sustained high number of reports associated with andrographis-containing medicines. A fatal case was reported in June 2024. Recalled products include BioCeuticals Armaforce and Clinical ImmuneForce, Faulding Immune Combat, PM Lung Support II, Immune Support Echinacea Plus, Chemists' Own Provance Immune Defence, 28 PLUS Immune Defence, and Nourex Professional Immune Defence. BioCeuticals has already ceased releasing stock for supply in response.

The cause of severe allergic reactions to andrographis is unknown, but risk factors include use of anti-inflammatory medicines such as ibuprofen, viral infections, exercise after ingestion, and alcohol use. The TGA announced the recall on 1 September but warned it will start taking regulatory action against retailers who have not removed the products from mid-October. The TGA stated that delaying the change would likely pose an imminent or serious risk of injury to consumers.

How it is being reported

• Andrographis recall: Cold and flu medicine recalled after allergic reaction spikePopular cold-and-flu medicines have been recalled across Australia after a major ingredient was linked to increasing and severe anaphylactic reactions.The West Australian · 12 Oct, 08:15
• Andrographis recall: Cold and flu medicine recalled after allergic reaction spikePopular cold-and-flu medicines have been recalled across Australia after a major ingredient was linked to increasing and severe anaphylactic reactions.Perth Now · 12 Oct, 08:15

In this story: Therapeutic Goods Administration · BioCeuticals · Australia

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