The medical regulator will consider reviewing warning labels on alternative medicines after a young father allegedly died from a severe allergic reaction.
Daily Mail Australia last month revealed father-of-two, Cale Agosta, allegedly suffered irreversible brain damage after taking BioCeuticals supplement, ArmaForce.
Mr Agosta’s wife, Tekita, has now been left with the task of raising their two-year-old and seven-month-old daughters alone.
The over-the-counter supplement’s ingredients include andrographis paniculata, olea europea, echinacea purpurea, zinc amino acid chelate and ascorbic acid vitamin C.
The Therapeutic Goods Administration will review whether current warning labels on cold and flu supplements are sufficient to address safety concerns over one of the ingredients.
A statement from the regulator last Sunday revealed reports of adverse reactions to andrographis paniculata had skyrocketed in recent years.
More than 200 reports had been received by the TGA since 2019, while only about 100 had been filed in the 14 years prior.
Those who had reactions to the ingredient reported suffering from anaphylaxis, seizure, swelling, nausea, throat tightness and dizziness.
Cale Agosta allegedly suffered irreversible brain damage after taking ArmaForce, which is a supplement that can be bought over-the-counter at pharmacies
Andrographis is commonly found in Indian and Chinese medicine to remedy cold and flu symptoms and immune support.
Of the more than 32,000 medicines on the Australian Register of Therapeutic Goods (ARTG), about 100 of which contain the ingredient.
The TGA revealed reports of allergic reactions to the ingredient sparked a safety review in 2015 which led to supplements using andrographis to use a safety label.
‘Andrographis may cause allergic reactions in some people,’ the label must read.
‘If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention.’
A statement from the TGA revealed the regulator has ‘continued to monitor reports of allergy and anaphylaxis for medicines containing andrographis’.
‘Little is currently known about the risk factors for andrographis allergy,’ the statement reads.
‘We are evaluating this safety concern and is considering whether the current label warning for andrographis is sufficient to address this risk.’
The regulator also urged those without reliable access to medical care or a history of allergic reactions ‘should be cautious using a medicine containing andrographis’.
A spokesman for Blackmores, Bioceuticals’ parent company, said all of its products complied with current TGA regulations.
The ingredient in ArmaForce has led to more than 200 reports of adverse reactions received by the regulator since 2019, while only about 100 had been filed in the 14 years prior
A friend of Mr Agosta’s family, Steve Brittain, launched a GoFundMe to help financially support 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.
It has currently raised just under $220,000 from over 1,000 donations in just over a month.
‘Cale is a loyal friend, a devoted husband and a loving father. An electrician by trade, he was the main provider for the family,’ Mr 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 it weekly for 20 years.
‘Forever helping others with odd jobs and asking nothing in return.’
Mr Agosta’s sister-in-law, Tegan, also shared a heartfelt message following his death.
‘Cale, I don’t have many words at this point. It doesn’t seem real and I am still in shock,’ she said.
‘How incredibly lucky we all were to have such a kind and funny person in our lives for the time that we did and how cruel life can be to take you so soon.
‘I could have never asked for a better brother in law and I will be forever grateful to have you as part of my life. You will be hugely missed each and everyday.
‘Thank you for creating and nurturing such a funny kid in Violet, I know you were so proud of her humor and that will be our solace going forward.’
The Therapeutic Goods Administration revealed they received a report of Mr Agosta’s day 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-supporting nutrients’ that is used to treat mild common cold and flu symptoms.
Andrographis decreases the severity of symptoms of mild upper respiratory tract infections, including sore throat, headache, runny nose, cough, fatigue and restless sleep. Zinc and vitamin C maintain healthy immune system function,’ the website reads.
Adults are told to take one tablet a day for a maximum of two weeks.
A warning label on the bottle reads: ‘Andrographis may cause taste disturbance, including loss of taste, loss of appetite, vomiting and abdominal discomfort.
‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention.’
Sydney University Professor Andrew McLachlan, who is the Head of School and Dean of Pharmacy, said the three main herbal ingredients in ArmaForce are also found in a range of other over-the-counter medicines.
He reassured that ArmaForce was a ‘safe and low risk’ medicine and that the severe reaction to the ingredient was ‘rare’.
Prof McLachlan said what allegedly happened to Mr Agosta was a ‘good reminder’ that people can have allergic reactions to all types of medicine.
A GoFundMe for Mr Agosta’s wife and two daughters (pictured) has raised just under $220,000 from over 1,000 donations in just over a month
Daily Mail Australia contacted BioCeutical’s parent company Blackmores for comment.
A spokesperson for Blackmores previously told this masthead: ‘The health and safety of our consumers is our number one priority, and we take suspected adverse events very seriously.
‘We have a strict pharmacovigilance system in place to investigate reports of suspected adverse events associated with our products.
‘We have been made aware 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.’