Medicines Regulator Urged to Recall Controversial Cold and Flu Herb

James De Bond was advised by a doctor not to take products containing Andrographis paniculata again.

In short:

Andrographis paniculata is in 84 products for cold and flu relief and immunity.

There is growing concern about severe allergic reactions to the herb.

What's next?

The Therapeutic Goods Administration may reclassify the herb, listed as low-risk.

James De Bond took a cold and flu supplement with Andrographis paniculata each winter.

The product contained the herb, used in Indian and Chinese medicine.

The ingredient is in 84 listed medicines for colds, flu, and immunity.

James De Bond had no side effects at first, but later ended up in hospital.

He felt tingling in his hands and feet, and struggled with his vision.

He collapsed on a shop floor and was scared.

James De Bond wants greater awareness about the potential risk of Andrographis paniculata.

He reported his reaction to the manufacturer, which offered a gift card.

He was alarmed by the lack of public information about the herb's risks.

He hadn't seen any communication about the risks, just a few articles.

Hundreds of allergic reactions

James De Bond's experience is similar to hundreds of adverse reactions reported.

The TGA received 1,368 adverse reports about the herb up until December.

The top reactions were loss of taste, anaphylactic reaction, and distorted sense of taste.

The regulator is considering removing Andrographis from the low-risk ingredients list.

BioCeuticals, the manufacturer, said its products meet current regulatory requirements.

The company will take steps after the TGA consultation outcome.

Safety concerns

The TGA's updated safety report follows an initial review in 2015.

Medicines with Andrographis have had warning labels since 2019.

Janine Dorsett had an anaphylactic reaction after taking a cold and flu supplement.

She wasn't aware of the possible risk posed by Andrographis.

She felt an overwhelming sense of dread after taking the supplement.

She started experiencing symptoms within minutes, including hives and swelling.

Paramedics gave her adrenaline to stop the anaphylactic reaction.

Janine Dorsett took the supplement bottle to hospital with her.

Her specialist concluded her reaction was likely related to Andrographis.

The doctor said there was literature about people with hypersensitivity to the herb.

The ABC tried to contact Swisse, the manufacturer, but got no response.

Janine Dorsett said she'd never take another supplement.

The paramedic said she was lucky to be alive.

No history of reactions

The TGA's report sought to answer why reactions occur after previous tolerance.

The presence of infection, non-steroidal anti-inflammatories, exercise, and alcohol may contribute.

The TGA concluded that more research is needed to understand the reactions.

ArmaForce, a product with Andrographis, had an updated warning label applied.

Several products with Andrographis contain Echinacea, which can also cause allergic reactions.

The TGA concluded that Echinacea was not the main trigger for anaphylaxis.

Since 2005, there have been only 10 anaphylaxis cases with Echinacea without Andrographis.

Echinacea was not the primary cause of anaphylaxis in Andrographis-containing medicines.

Push for a recall

If the TGA removes Andrographis from the permissible ingredients list, it won't be allowed in low-risk medicines.

The consultation period was extended to May 8 to support stakeholder engagement.

The length of the review process depends on the submissions received.

James De Bond believes more awareness is needed about the potential risks.

He thinks people won't know to dump the product unless they're aware of the risk.

If a product is clearly dangerous, there should be a recall or announcement.

A TGA spokesperson said restricting access to Andrographis-containing medicines may be considered.

Cancellation and recall are potential regulatory actions that may be considered.