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The first is to inform readers of news and happenings in the e-Health domain, both here in Australia and world-wide.
The second is to provide commentary on e-Health in Australia and to foster improvement where I can.
The third is to encourage discussion of the matters raised in the blog so hopefully readers can get a balanced view of what is really happening and what successes are being achieved.
Tuesday, July 09, 2024
The TGA Really Needs To Get Its Skates On And Get This Stuff Off The Market!
is appeared last week
TGA to review warnings after young father’s supplement
death
The
medicines regulator will reconsider warnings for some cold and flu tablets,
after a young father died from a severe allergic reaction last month.
There
has been an increase in reported adverse reactions to andrographis paniculata,
an ingredient in several brands of over-the-counter “immunity” capsules, such
as BioCeuticals’ ArmaForce.
Of
the 300 reports of anaphylaxis or hypersensitivity reactions to medicines
containing the ingredient since 2005, more than 200 have been logged since
2019.
Reported reactions included anaphylaxis, seizure, swelling, nausea, throat tightness and dizziness. The Therapeutic Goods Administration received its first report of a death following use of the alternative medicine in June: 37-year-old Cale Agosta, a Queensland father of two who is suspected to have had a fatal reaction to ArmaForce. More than 80 per cent of the adverse events reported were for medicines which also contained echinacea, another herbal ingredient from the daisy family which has been reported to also cause allergic reactions.
The regulator introduced labelling requirements for products containing andrographis in 2019, following a safety review.
Labels must warn the ingredient can cause allergic reactions in some people and advise that, if the consumer has a severe reaction, such as anaphylaxis, they should stop use and seek immediate medical attention.
However, the regulator is reconsidering whether this is sufficient to address safety concerns.
The risk factors for severe reactions to andrographis are unknown.
Adverse reports data suggests subsequent reactions may be more severe. However, in some cases the first reported reaction was severe, even when a product was previously used without incident.
In advice published last week, the regulator advised against the use of the supplements in people with a history of severe allergic reactions to any trigger.
“[They] should be cautious using a medicine containing andrographis and stop using it at the first sign of any allergic reaction,” it advised.
Royal Australian College of GPs chair Dr Lara Roeske said winter viruses meant more people were using immunity supplements.
“It is a really timely reminder to read the label and let your health practitioner know if you do have allergies,” she said, noting people with existing allergies were typically at higher risk of having a reaction to a new substance.
“These symptoms will be much more severe than typical cold and flu symptoms, and symptoms of hypersensitivity happen pretty soon after you’ve ingested the medication,” she added.
Dr Ian Musgrave, a pharmicology researcher at the University of Adelaide, said there was a limited understanding of adverse events to alternative medicines because, although some have been used for centuries, reactions may not have been linked to the ingredient. People also may not report using these products to a medical practitioner, he said.
While such reactions are rare, Musgrave said the public needed to realise that “low” risk is not “no” risk, and carefully read warnings.
“People may not necessarily read the warnings, as they believe that ‘natural’ medicines have no side effects,” he said.
“The tragic death is a wake-call for people to be more aware that herbal and alternative medicines have the potential for harm.”
A spokesperson for Blackmores, Bioceuticals’ parent company, said it took adverse events seriously and all of its products complied with TGA regulations.
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