TGA Proposes Ban on Popular Herbal Supplement After Life-Threatening Allergy Risks

The Therapeutic Goods Administration (TGA), Australia's medicines regulator, has proposed removing the herbal ingredient andrographis (Andrographis paniculata) from its list of permitted low-risk substances following a safety review.

The review concluded that the herb is associated with a risk of severe, life-threatening allergic reactions, including anaphylaxis, which is considered inconsistent with the low-risk framework for listed medicines.

The TGA has opened a consultation period with stakeholders on the proposal.

Safety Review Findings and Adverse Event Data

The TGA's safety review analyzed adverse event reports dating back to 2005, when the regulator first received reports of anaphylaxis and hypersensitivity linked to andrographis.

• Total Reports: Since 2005, the TGA has received more than 1,300 adverse event reports for medicines containing andrographis. One source specifies this number as 1,368 reports.
• Anaphylaxis Cases: The reports include 287 incidents of anaphylaxis.
• Fatalities: The TGA received a report of a fatal anaphylactic reaction linked to andrographis use in June 2024.
• Other Reactions: Reported serious reactions also include a case of drug-induced liver injury.

The sustained high reporting pattern indicates a risk of life-threatening anaphylaxis that is unpredictable and can occur regardless of prior use, even in individuals with no history of allergies or asthma. Symptoms of anaphylaxis typically begin within 30 minutes of ingestion.

Proposed Regulatory Action

The TGA is proposing to remove andrographis from the Permissible Ingredients Determination for listed medicines. If enacted:

• Andrographis would no longer be permitted in low-risk, over-the-counter listed medicine products.
• It would remain available for use in prescription medicines and registered non-prescription medicines, where a different regulatory framework applies.

The TGA has initiated a consultation period with health professionals, manufacturers, consumer groups, and other stakeholders. The consultation closes on April 30. The regulator stated it is legally required to undertake this consultation to understand all potential impacts before making a final regulatory decision.

"We are legally required to undertake meaningful consultation with affected parties to understand all risks, including impacts on sponsors, markets, and individuals, before making regulatory decisions." — TGA Spokesperson

History of Previous Mitigation Measures

The TGA has taken several steps over the past decade to address the risks, which it states have not substantially reduced the incidence of serious adverse reactions.

• 2015: The TGA issued a public alert after a safety review confirmed the herb could cause serious allergic reactions.
• 2019-2020: Following a spike in adverse event reports, the TGA mandated warning labels on products containing andrographis. These labels were implemented between December 2019 and May 2020.
• 2020 Onward: Despite the labeling changes, the TGA recorded another spike in adverse events starting in May 2020, coinciding with the early months of the COVID-19 pandemic. Significant spikes continued in 2022, 2023, 2024, and 2025.
• Voluntary Measures: Some industry groups responded by voluntarily implementing additional labeling changes and moving products behind pharmacy counters to facilitate pharmacist consultation.

Usage and Availability

• Traditional Use: Andrographis is a herb used in traditional Indian and Chinese medicine for centuries to treat colds, flu, upper respiratory tract infections, inflammation, and fever.
• Current Products: In Australia, it is used in approximately 84 listed medicines marketed for cold and flu symptoms and immunity. It is frequently sold in multi-ingredient preparations combined with echinacea.
• Key Statistic: In 2024, over 80% of adverse event reports for herbal preparations involved products containing both andrographis and echinacea.
• Access: Products are currently available without a prescription in pharmacies, supermarkets, and health food stores.

Statements and Perspectives

BioCeuticals (Seller of ArmaForce)

BioCeuticals stated that consumer safety is a priority. The company noted that all required warnings are on current packaging and that front-of-pack boxed warnings were introduced in 2024. BioCeuticals confirmed it will review the TGA's consultation and take any required steps.

Professor Connie Katelaris AM (Immunology and Allergy Expert, Western Sydney University)

Professor Katelaris has consistently highlighted the risks of andrographis, citing global data on adverse responses. She supports the TGA's findings regarding the inadequacy of warnings and advocates for the removal of these products from shelves. She has criticized the consultation process as unnecessary, arguing that existing data clearly demonstrates the herb's risks.

Carmen Wells (Patient)

Carmen Wells reported developing drug-induced autoimmune hepatitis after using an andrographis-containing supplement in 2019. She expressed satisfaction with the TGA's findings but also frustration regarding the time taken for the data to be released.

Joanna Harnett (Associate Professor, University of Sydney School of Pharmacy)

Harnett described the allergic reactions as "very concerning and clinically relevant" and called for action to prevent further harm. She noted that current concerns have arisen largely in the context of widespread self-selection rather than use within traditional systems under practitioner guidance.

Magdalena Simonis (Spokesperson, Royal Australian College of General Practitioners)

Simonis stated that anaphylaxis is a life-threatening condition and that deaths associated with andrographis are significant. She noted that patients often do not volunteer information about natural herbs and supplements they are taking to their doctors.

Jon Wardle (Director, National Centre for Naturopathic Medicine, Southern Cross University)

Wardle stated that the context in which these remedies are used, including dosage and practitioner guidance, differs from self-prescribed over-the-counter products. He noted that natural products can be powerful pharmacological agents.

Patient Experience: A Case Report

On December 30, a patient named Kerry Smith experienced a severe allergic reaction after taking ArmaForce. Within minutes of ingestion, she developed itching, severe stomach cramps, difficulty breathing, and a swollen tongue. Her husband administered an EpiPen, and she was transported to the hospital. Emergency doctors identified andrographis as the likely cause.

"I misinterpreted the existing warning label, believing it applied only to previous reactions to the product." — Kerry Smith

Ms. Smith fully recovered after a night in the hospital.

Broader Context

Complementary Medicine Use

Joanna Harnett stated that at any point in time, an estimated 50% of the general population uses some complementary medicine product.

Healthcare Access and Costs

Australian Bureau of Statistics data from November indicated that roughly one in seven Australians delayed or avoided seeing a GP due to cost. Average out-of-pocket costs for a GP visit have risen beyond $50, while bulk-billing rates have remained at around 77.6%. The number of daily GP consultations has declined. Some experts have suggested these factors may be contributing to a rise in self-directed care, including the use of over-the-counter supplements.

TGA Recommendations

• Read the safety review before taking any product containing andrographis.
• Anyone experiencing symptoms of an allergic reaction should stop using the product and seek medical advice.
• For suspected anaphylaxis, seek emergency medical help immediately.
• Consult a health professional before taking any medication, including herbal supplements.