Calls for stronger warnings on iron infusion risks
Quick Look
- Kate Russell, a 46-year-old Australian woman, suffered severe hypophosphataemia after an iron infusion, leading to an induced coma and a year-long recovery.
- Medical experts note rising cases of this complication linked to ferric carboxymaltose in Australia, while the US FDA has issued a boxed warning that Australian regulators are evaluating.
AI-generated summary
Why It Matters
Iron infusions are commonly used to treat iron deficiency, particularly in women of reproductive age. Ferric carboxymaltose is a widely used intravenous iron preparation in Australia. Hypophosphataemia is a known but under-recognized complication where phosphate levels drop dangerously low after infusion.
Kate Russell thought getting an iron infusion would help alleviate her fatigue, but instead she says the treatment led to a condition that landed her in an induced coma.
The 46-year-old said she was not warned about the potential risks and the 12 months since her admission to Toowoomba Hospital's intensive care unit (ICU) had been "devastating".
Ms Russell said she was diagnosed with severe hypophosphataemia, where phosphate levels in the blood become dangerously low, which can occur following an iron infusion.
"It's taken a huge financial toll on my family."
She said the only risk associated with having an iron infusion she was informed about was iron staining on her arm where the intravenous needle was inserted.
But Ms Russell said she started experiencing muscle weakness and heart palpitations after her treatment in October last year, and she continued to deteriorate for a month before she collapsed in a doctor's surgery and was rushed to hospital.
She said when the cause of her illness was identified, she was given phosphate replacement therapy.
Iron infusion risk becoming more common
Medical experts say hypophosphataemia is a complication that can occur with the use of ferric carboxymaltose, an intravenous iron preparation commonly administered in Australia.
Recent data shows it is becoming more common as the use of iron infusions surges across Australia, particularly among women of reproductive age.
There were 46 reports of hypophosphataemia associated with ferric carboxymaltose in 2025, compared with 17 cases in 2020 according to the Therapeutic Goods Administration (TGA).
Bond University assistant professor and general practitioner Kieran Le Plastrier said several patients had presented to his practice feeling "generally unwell" after receiving an iron infusion this year and blood tests had shown they all had low phosphate.
Dr Le Plastrier said ferric carboxymaltose caused hypophosphataemia by preventing the breakdown of a hormone, which in turn signalled the kidneys to excrete more phosphate than usual.
"All versions of infusions can do it, but this particular product has a high rate because it blocks the conversion of certain cofactors in the gut and in the blood from being able to recycle and absorb phosphate," he said.
He said patients experiencing low phosphate levels were treated with an oral replacement and usually returned to regular health within a few months in mild cases.
US strengthens warnings
Last month, the US Food and Drug Administration (FDA) brought in its strongest safety warning, a boxed warning, for ferric carboxymaltose due to the risks of hypophosphataemia.
The Therapeutic Goods Administration (TGA) said it was "aware of and currently evaluating" the move in the United States, but did not say whether Australia would adopt the same warning.
The organisation said it routinely monitored safety information and added that action taken by overseas regulators did not automatically result in the same action in Australia.
Royal Australian College of General Practitioners (RACGP) co-deputy chair Aadhil Aziz said Australian regulators should consider following the US to ensure patients and healthcare professionals were better informed about the potential risk.
"Having a warning doesn't mean that you don't do this," Dr Aziz said.
He said patients should discuss dietary changes or oral iron tablets with their regular doctor before opting for an iron infusion.
For patients who required intravenous iron, he said checking phosphate levels before treatment could also help identify potential risk factors.
Meanwhile, Ms Russell said it had taken her almost a year to recover, and she had only recently returned to work full-time as a physical education teacher.
She urged anyone thinking about getting iron infusions to do their research before getting the treatment.
"I don't think anyone should have to experience this."
What to Watch
AI outlook — possibilities, not facts
The Therapeutic Goods Administration will issue a safety update or warning regarding ferric carboxymaltose and hypophosphataemia within the next 3 months
Likely · Within months
Open Questions
- Will the TGA adopt a boxed warning for ferric carboxymaltose matching the FDA's action?
- How many Australian patients have suffered severe complications from iron infusions beyond the reported 46 cases in 2025?
- What specific guidance will Australian regulators provide to clinicians about monitoring phosphate levels before iron infusions?