The medical regulator will consider reviewing warning labels on alternative medicines after a young father reportedly died from a severe allergic reaction.
Last month, the Daily Mail Australia revealed that father-of-two Cale Agosta allegedly suffered irreversible brain damage after taking BioCeuticals’ supplement ArmaForce.
Mr Agosta’s wife, Tekita, is now tasked with raising their two-year-old and seven-month-old daughters alone.
The over-the-counter supplement ingredients include andrographis paniculata, olea europea, echinacea purpurea, zinc amino acid chelate, and vitamin C with ascorbic acid.
The Therapeutic Goods Administration will review whether current warning labels on cold and flu supplements are sufficient to address safety concerns about one of the ingredients.
A statement from the regulator last Sunday revealed that reports of adverse reactions to andrographis paniculata had skyrocketed in recent years.
The TGA had received more than 200 reports since 2019, compared with only around 100 in the previous 14 years.
Those who had reactions to the ingredient reported experiencing anaphylaxis, seizures, swelling, nausea, throat tightness and dizziness.
Cale Agosta reportedly suffered irreversible brain damage after taking ArmaForce, which is a supplement that can be purchased over the counter in pharmacies.
Andrographis is commonly used in Indian and Chinese medicine to remedy cold and flu symptoms and boost the immune system.
Of the more than 32,000 medicines on the Australian Register of Therapeutic Goods (ARTG), approximately 100 contain the ingredient.
The TGA revealed reports of allergic reactions to the ingredient which prompted a safety review in 2015 that led to supplements using andrographis using a safety label.
‘Andrographis may cause allergic reactions in some people,’ the label should read.
‘If you have a serious reaction (such as anaphylaxis), stop use and seek immediate medical attention.’
A statement from the TGA revealed that the regulator “has continued to monitor reports of allergy and anaphylaxis to medicines containing andrographis”.
“Little is currently known about the risk factors for andrographis allergy,” the statement said.
“We are evaluating this safety issue and considering whether the current label warning for andrographis is sufficient to address this risk.”
The regulator also urged that those who do not have reliable access to medical care or a history of allergic reactions “should exercise caution when using a medicine containing andrographis.”
A spokesman for Blackmores, the parent company of Bioceuticals, said all its products complied with current TGA regulations.
The ArmaForce ingredient has prompted more than 200 adverse reaction reports received by the regulator since 2019, compared with only about 100 in the previous 14 years.
A family friend of Mr. Agosta, Steve Brittain, launched a GoFundMe campaign to financially assist Ms. Agosta and her two children.
A friend of Mr. Agosta’s family, Steve Brittain, launched a GoFundMe to help financially support Ms. Agosta and her two children.
So far, it has raised nearly $220,000 from more than 1,000 donations in just over a month.
“Cale is a loyal friend, devoted husband and loving father. An electrician by trade, he was the family’s primary breadwinner,” Brittain wrote on GoFundMe.
‘If the roles were reversed, I know Cale would give us the shirt off his back, as I watched him do weekly for 20 years.
‘Always helping others with odd jobs and without asking for anything in return.’
Agosta’s sister-in-law, Tegan, also shared an emotional message following his death.
“Cale, I don’t have many words right now. It doesn’t seem real and I’m still in shock,” he said.
‘How incredibly lucky we all were to have such a kind and funny person in our lives for as long as we did and how cruel life can be to take you away so soon.
“I could never have asked for a better brother-in-law and I will be forever grateful to have you as a part of my life. You will be missed dearly every day.
“Thank you for creating and nurturing such a fun-loving little girl like Violet. I know you were very proud of her humor and that will be our comfort in the future.”
The Therapeutic Goods Administration said it received a report from Mr. Agosta on Monday and will investigate whether a warning label is sufficient to address the ingredient’s risk.
ArmaForce is described as a “comprehensive vegan formula combining andrographis and immune-boosting nutrients” used to treat mild symptoms of the common cold and flu.
“Andrographis reduces the severity of symptoms of mild upper respiratory tract infections, such as sore throat, headache, runny nose, cough, fatigue, and poor sleep. Zinc and vitamin C maintain healthy immune system function,” the website reads.
Adults are recommended to take one tablet daily for up to two weeks.
A warning label on the bottle reads: ‘Andrographis may cause taste disturbances including loss of taste, loss of appetite, vomiting, and abdominal discomfort.
‘Andrographis may cause allergic reactions in some people. If you have a serious reaction (such as anaphylaxis), stop using it and get medical help right away.’
Andrew McLachlan, a professor at the University of Sydney, head of the Faculty and dean of Pharmacy, said the three main herbal ingredients in ArmaForce are also found in a variety of other over-the-counter medications.
He said ArmaForce was a “safe and low-risk” drug and that a serious reaction to the ingredient was “rare.”
Professor McLachlan said what allegedly happened to Mr Agosta was a “good reminder” that people can have allergic reactions to all types of medicines.
A GoFundMe campaign for Mr Agosta’s wife and two daughters (pictured) has raised nearly $220,000 from more than 1,000 donations in just over a month.
Daily Mail Australia has contacted BioCeutical’s parent company, Blackmores, for comment.
A Blackmores spokesperson previously told this headline: ‘The health and safety of our consumers is our number one priority and we take suspected adverse events extremely seriously.
‘We have a strict pharmacovigilance system in place to investigate reports of suspected adverse events associated with our products.
‘We have been informed of the Go Fund Me page and are investigating the alleged adverse event.
‘If consumers or their family members have experienced a suspected adverse event associated with our product, we encourage them to contact the BioCeuticals Naturopathic Advisory Team on 1300 650 455 or by email at advisory@bioceuticals.com.au.’
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