Andrographis paniculata (Andrographis) is a popular ingredient, commonly used for immunity, colds and flu. In July 2024 the Therapeutic Goods Administration (TGA) published an updated safety advisory about Andrographis and allergy, following reports of anaphylaxis and/or hypersensitivity reactions to complementary medicines containing this herb.
Anaphylaxis and hypersensitivity reactions can be caused by a variety of commonly encountered substances and medicines, including peanuts, shellfish, cow’s milk, penicillin and bee products. It has been recognised that allergic reactions to Andrographis, while still very rare, may be more likely than for other herbal medicines.
In 2019, additional regulatory measures on products listed in the Australian Register of Therapeutic Goods (ARTG) were implemented to help inform consumers of the potential risk of allergy in some individuals. Australian products that are regulated by the TGA and which have an ‘AUST L’ number on the label, are required to display the following warning statement:
“Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention” (or words to that effect).
Currently, little is known about whether there are any specific risk factors for allergy to Andrographis. However, as for many allergies, such reactions are considered rare and unpredictable. They may be more pronounced in sensitive individuals, such as those who have other allergies or a history of an anaphylactic reaction to any substance.
Complementary Medicines Australia Chief Executive Officer, John O’Doherty, said “Consumers need to be alert to the potential for an allergic reaction to any medicine, and seek urgent medical attention if any signs or symptoms of a severe allergic reaction occur.”
These symptoms may include skin reactions, like hives or rashes, tingling mouth, itchiness or swelling of the lips, face and eyes, shortness of breath or wheezing, and dizziness.
Warning labels on complementary medicines directly communicate important information to consumers, about potential risks associated with their use. These labels and related advertising materials must comply with strict advertising rules, which require warning statements in all advertising to “ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.”
“The TGA plays a pivotal role in disseminating important information to both healthcare professionals and to consumers through safety advisories. Similarly, labels of Australian complementary medicines that are regulated by the TGA provide essential information for consumers and individuals must read and observe the label warnings on medicines,” Mr O’Doherty said.
It is important to purchase Australian regulated supplements that have an AUST L, AUST LA or AUST R number on the label, as medicines that do not display these numbers may not be approved for sale in Australia, and are not subject to the same regulatory oversight, manufacturing requirements, and label warnings as required by the TGA. This is especially a concern for products purchased online.
