On December 30, Kerry Smith experienced a severe allergic reaction after taking ArmaForce, a complementary medicine. Within minutes of ingestion, Ms. Smith developed itching, severe stomach cramps, difficulty breathing, and a swollen tongue. Her husband administered an EpiPen, and she was transported to the hospital.
Identification of Allergen and Regulatory History
Emergency doctors identified Andrographis paniculata, an ingredient in ArmaForce, as the likely cause of the reaction. Ms. Smith stated that hospital staff reported numerous similar presentations.
The Therapeutic Goods Administration (TGA) has monitored Andrographis paniculata since 2008 due to adverse event reports and anaphylaxis concerns.
- Several safety alerts have been issued.
- In 2019, a label warning requirement for products containing Andrographis was introduced.
- Adverse event reports to the TGA have continued to increase, including a fatal case of anaphylaxis reported in 2024.
- The TGA has received 1,365 adverse event reports for medicines containing Andrographis paniculata, with 859 linked to ArmaForce products.
- A total of 286 reports of anaphylaxis involved Andrographis paniculata medicines, including 188 for ArmaForce products.
Manufacturer's Response and Warning Labels
BioCeuticals, the seller of ArmaForce, stated that products containing Andrographis may cause allergic reactions, including anaphylaxis in rare cases. The company indicated that all required warnings are on current product packaging and that front-of-pack boxed warnings were introduced in 2024 to enhance consumer awareness.
Ms. Smith reported misinterpreting the warning label, believing it applied only to previous reactions to ArmaForce, not general allergy history. She also noted that her allergy history was not queried by the pharmacist.
Expert Commentary on Complementary Medicines
Dr. Michael O'Sullivan, president of the Australasian Society of Clinical Immunology and Allergy, commented that anyone could be at risk of a reaction to medication, including anaphylaxis, regardless of prior allergies. He emphasized that over-the-counter complementary medicines can carry similar risks of side effects as prescription medication.
Dr. O'Sullivan noted that the reason for Andrographis's high number of allergic reactions is unclear and advised patients to weigh the risks. He added that proven effective medications for common viral infections are recommended by GPs, and such evidence is often lacking for many complementary medicines.
Ms. Smith fully recovered after spending a night in the hospital.