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Call for Medicines Authority to Withdraw Disputed Herbal Cold and Flu Remedy

By investigative journalist

Andrographis paniculata, a herb commonly found in approximately 84 products aimed at alleviating cold and flu symptoms and enhancing immunity, has come under scrutiny due to rising reports of severe allergic reactions associated with its use.

The Therapeutic Goods Administration (TGA) is currently evaluating the potential reclassification of this herb, which is currently categorized as a low-risk ingredient.

James De Bond, who used to rely on a cold and flu supplement each winter to help him fend off seasonal illnesses, experienced a shocking turn of events last July. This supplement included Andrographis paniculata, a herb traditionally utilized in Indian and Chinese medicine.

Initially, Mr. De Bond reported no adverse effects from the supplement and felt confident that it was effective in maintaining his health. However, during a subsequent use, he collapsed while shopping and ended up hospitalized.

“I began to feel a tingling sensation in my hands and feet,” he recounted. “I realized that something was seriously wrong when my vision started to fail me. The next thing I knew, I was on the ground, leaving the cashier visibly shaken.” After this alarming incident, his doctor firmly advised him against using the supplement again.

Afterward, Mr. De Bond contacted the manufacturer of the product, who responded with a gift card as compensation for his distress. He expressed his concern over the insufficient public awareness regarding the potential risks associated with Andrographis paniculata and the ease with which such products can be obtained.

“I hadn’t encountered any warnings about this before; there were merely a few articles highlighting serious incidents involving others. It was quite startling to realize how little information was available,” he stated.

Mr. De Bond’s ordeal mirrors hundreds of other adverse reactions reported to the TGA. An updated safety review released on April 8 revealed that the agency had recorded 1,368 adverse reports related to medicines containing this herb up until December. The most common reactions included ageusia (loss of taste), anaphylaxis (characterized by airway swelling, breathing difficulties, hives, low blood pressure, and shock), and dysgeusia (distorted taste).

As a result, the regulatory agency is contemplating removing Andrographis paniculata from its list of low-risk ingredients, which are available in various retail locations, including pharmacies. BioCeuticals, the manufacturer of the supplement that Mr. De Bond consumed, stated that all its products comply with current TGA regulations and that they will take necessary actions following the TGA’s consultation outcomes.

This updated safety report follows a previous review conducted in 2015, which highlighted the potential for serious allergic reactions, including anaphylaxis, related to the herb. Since 2019, products containing Andrographis paniculata have been required to display warning labels.

Janine Dorsett, another individual who has used a cold and flu supplement containing the herb, shared her experience of an alarming allergic reaction. In February 2020, after taking the supplement, she felt an overwhelming sense of dread before experiencing a series of distressing symptoms including swollen lips, hives, bloodshot eyes, and overall body swelling.

Despite taking a strong antihistamine, her condition worsened, prompting her to request her husband to call for emergency assistance. Paramedics administered multiple doses of adrenaline en route to the hospital to counteract the anaphylactic reaction.

“I was absolutely terrified. I truly believed I was going to die,” Ms. Dorsett recalled, noting that the paramedics seemed surprised by the severity of her situation.

Ms. Dorsett had no prior history of allergies and had taken Swisse Immune Forte, a supplement containing Andrographis paniculata. A specialist later concluded that her reaction was likely related to this ingredient, pointing out existing literature on hypersensitivity to it.

Although the ABC has attempted to reach Swisse for a comment, no response has been received. Ms. Dorsett expressed her relief regarding the TGA’s regulatory actions but indicated she would never consider taking another supplement.

“Absolutely not, especially since I had taken it previously without any issues; I wouldn’t risk it again,” she asserted. “The paramedic warned me that had I tried to sleep it off, I might not be here today.”

The TGA’s report addresses a common query from individuals like Mr. De Bond and Ms. Dorsett, who had previously taken Andrographis paniculata without incident. The agency noted that the reasons for reactions occurring after prior tolerance remain unclear. Factors such as infections, the use of non-steroidal anti-inflammatories, physical exercise, and alcohol consumption may contribute to these severe responses.

While the TGA acknowledged the need for further research to understand the triggers of severe reactions, it emphasized the necessity of regulatory action in the meantime.


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