Herb in Cold and Flu Products Linked to Life-Threatening Anaphylaxis

The Therapeutic Goods Administration (TGA) has linked a herbal ingredient commonly found in cold and flu supplements to the risk of life-threatening anaphylaxis. The regulator’s safety review focused on Andrographis paniculata, a herb used in approximately 84 listed medicines in Australia marketed for immunity boosting and the relief of cold and flu symptoms.

Listed medicines are regulated as low-risk products and can be purchased from retail outlets, including pharmacies. However, the TGA has concluded that the risk profile of Andrographis paniculata is inconsistent with this low-risk regulatory framework.

Safety Review Findings

The TGA’s safety review found that individuals taking supplements containing Andrographis have experienced reactions that are described as unpredictable. These reactions can occur regardless of whether a person is using the product for the first time or has a history of previous use.

Since 2005, the regulator has received 1,368 reports of adverse reactions related to medicines containing the herb. Among these reports, 287 incidents were identified as anaphylaxis.

The sustained high reporting pattern since 2019 indicates that Andrographis is associated with risk of life-threatening anaphylaxis which is inconsistent with the low-risk regulatory framework for listed medicines

TGA report

The TGA has warned that anaphylaxis associated with Andrographis can be rapid and unpredictable. In one reported case, a woman named Carmen Wells suffered liver damage after taking a cold and flu supplement containing the herb.

Regulatory Action and Next Steps

The TGA has determined that implementing stronger warning labels for products containing Andrographis paniculata would be inadequate to manage the risks associated with the ingredient.

the regulator plans to consult with stakeholders regarding the removal of the herb from the list of low-risk ingredients. This move would change how medicines containing Andrographis are regulated and sold to the public.

Context of Andrographis paniculata

Andrographis paniculata is used in a variety of herbal preparations. According to TGA safety alerts issued as early as July 2, 2024, medicines containing this herb may cause allergic reactions, including those that are life-threatening.

The current regulatory status as a listed medicine allows these products to be sold widely in retail environments. The TGA’s findings suggest that the frequency and severity of adverse reactions, particularly the high number of anaphylaxis cases, necessitate a stricter regulatory approach.