Cold-and-flu medicines containing the herb andrographis have been recalled across Australia after a sustained rise in reports of severe allergic reactions, including anaphylaxis.
The Therapeutic Goods Administration (TGA) said products containing Andrographis paniculata would no longer be treated as low-risk listed medicines. It said a fatal case had been reported in June 2024.
“Following a large increase in the number of reports of anaphylaxis in 2019, the TGA has continued to receive a sustained high number of reports of anaphylaxis associated with Andrographis-containing medicines,” the regulator said.
The TGA said the number of reports was “inconsistent with a listed medicine that would be considered a low-risk medicine”. Its announcement was made on September 1, with regulatory action against retailers that have not withdrawn the products due to begin in mid-October.
Andrographis medicines recalled
Products affected include BioCeuticals Armaforce and Clinical ImmuneForce, Faulding Immune Combat, PM Lung Support II and Immune Support Echinacea Plus.
Chemists’ Own Provance Immune Defence and 28 PLUS Immune Defence have also been recalled, along with Nourex Professional Immune Defence. BioCeuticals has reportedly ceased releasing stock for supply in response to the recall.
Andrographis is used in Chinese and Indian traditional medicine to treat influenza and the common cold. The products are commonly sold over the counter in pharmacies, health food shops and supermarkets.
The reason the herb can trigger severe allergic reactions is not known. The TGA said possible factors that may increase the risk of anaphylaxis include taking anti-inflammatory medicines such as ibuprofen, viral infections, exercising after taking the medicine and alcohol use.
“The TGA considers that delaying implementation of this change would likely pose an imminent or serious risk of injury to consumers,” it said.
