The medical watchdog is considering revising warning labels on alternative medicines after a young father is believed to have died from a severe allergic reaction.
Daily Mail Australia reported last month that father of two Cale Agosta reportedly suffered irreversible brain damage after taking the BioCeuticals supplement ArmaForce.
Mr Agosta’s wife, Tekita, is now left to raise their two- and seven-month-old daughters alone.
The ingredients of the over-the-counter supplement include andrographis paniculata, olea europea, echinacea purpurea, zinc amino acid chelate, and ascorbic acidvitamin C.
The Therapeutic Goods Administration will investigate 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 showed that the number of reports of adverse reactions to andrographis paniculata has increased dramatically in recent years.
Since 2019, the TGA has received more than 200 reports, compared to only around 100 submitted in the previous 14 years.
People who have had a reaction to the ingredient have reported experiencing anaphylaxis, seizures, swelling, nausea, tightness in the throat and dizziness.
Cale Agosta is said to have suffered irreversible brain damage after taking ArmaForce, a supplement available over the counter at pharmacies
Andrographis is widely used in Indian and Chinese medicine to relieve cold and flu symptoms and support the immune system.
Of the more than 32,000 medicines on the Australian Register of Therapeutic Goods (ARTG), approximately 100 contain this ingredient.
The TGA uncovered reports of allergic reactions to the ingredient, prompting a safety review in 2015. This led to andrographis supplements being given a safety label.
“Andrographis may cause allergic reactions in some people,” the label should state.
‘If you experience a severe reaction (such as anaphylaxis), discontinue use and seek immediate medical attention.’
A statement from the TGA said the regulator “continues to monitor reports of allergies 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 concern and considering whether the current label warning for andrographis is sufficient to address this risk.”
The regulator also advised people who do not have reliable access to medical care or who have had allergic reactions in the past to “be cautious when using medicines containing andrographis”.
A spokesperson for Blackmores, the parent company of Bioceuticals, said all its products comply with current TGA regulations.
The ingredient in ArmaForce has led to more than 200 adverse event reports received by the regulator since 2019, compared to only about 100 filed in the previous 14 years.
A friend of Mr. Agosta’s family, Steve Brittain, launched a GoFundMe to financially support Mrs. Agosta and her two children
A friend of Mr Agosta’s family, Steve Brittain, launched a GoFundMe to financially support Mrs. Agosta and her two children.
In just over a month, more than $220,000 has now been raised from over 1,000 donations.
“Cale was a loyal friend, devoted husband, and loving father. An electrician by trade, he was the primary breadwinner for his family,” Mr. Brittain wrote on GoFundMe.
‘If the tables were turned, I’m sure Cale would give us his last kiss, because I’ve seen him do it every week for 20 years.
‘Always helping others with chores and asking nothing in return.’
Mr Agosta’s sister-in-law, Tegan, also shared a touching message following his passing.
“Cale, I don’t have many words right now. It doesn’t seem real and I’m still in shock,” she said.
‘How incredibly lucky we all were to have such a kind and funny person in our lives. And how cruel life can be when you die so early.
“I could never have asked for a better brother in law and I will be forever grateful that you are a part of my life. You will be missed dearly every day.
“Thank you for making and raising Violet such a funny child. I know you were so proud of her humor and that will be a comfort to us in the future.”
The Therapeutic Goods Administration has announced that it has received a report about Mr Agosta’s day and will investigate whether a warning label is sufficient to address the risk posed by the ingredient.
ArmaForce is described as a “complete vegan formula combining andrographis and immune-supporting nutrients” and is used to treat mild cold and flu symptoms.
Andrographis reduces the severity of symptoms of mild upper respiratory infections, including sore throat, headache, runny nose, cough, fatigue, and restless sleep. Zinc and vitamin C maintain healthy immune system function,” the website states.
Adults are advised to take one tablet daily for a maximum of two weeks.
The bottle label carries the following warning: ‘Andrographis may cause taste disturbances, including loss of taste, loss of appetite, vomiting, and abdominal discomfort.
‘Andrographis can cause allergic reactions in some people. If you have a serious reaction (such as anaphylaxis), stop taking it and seek immediate medical attention.’
Andrew McLachlan, a professor at the University of Sydney and head of the Faculty of Pharmacy, said the three key plant-based ingredients in ArmaForce are also found in a range of other over-the-counter medicines.
He assured that ArmaForce is a “safe and low-risk” drug and that a serious reaction to the ingredient is “rare”.
Professor McLachlan said what happened to Mr Agosta was a “good reminder” that people can have allergic reactions to all types of medicines.
A GoFundMe for Mr. Agosta’s wife and two daughters (pictured) has raised just under $220,000 in just over a month from more than 1,000 donations
Daily Mail Australia contacted Blackmores, BioCeutical’s parent company, for comment.
A Blackmores spokesperson said earlier in this press release: ‘The health and safety of our consumers is our highest priority and we take any suspected adverse events extremely seriously.
‘We operate a strict pharmacovigilance system to investigate reports of suspected adverse reactions to 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 believe they have experienced an adverse reaction related to our product, we encourage them to contact the BioCeuticals Naturopathic Advisory Team on 1300 650 455 or by email at advisory@bioceuticals.com.au.’
