Alarm over unregulated methylene blue use
A blue dye meant to treat a rare blood disorder has become Australia's latest potentially deadly wellness fad, prompting urgent warnings from poison experts.
Australians are taking a blue dye used to treat a rare disorder for unproven wellness reasons, with the product prompting surging calls to poisons centres and potentially involved in several deaths.
Methylene blue is approved to treat methaemoglobinaemia, a rare blood condition,but is spruiked by alternative wellness figures and online vendors for brain function and anti-ageing purposes.
TikTokers have taken to flaunting their tongues that have been tinged blue by the product, which is also used as a staining agent and in veterinary medicine.
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The Therapeutic Goods Administration (TGA) recently issued a warning about “increasing importation and use of unregistered oral methylene blue” products in Australia.
“These products are being promoted for unapproved (off-label) uses, such as cognitive enhancement, mood improvement, and anti-ageing effects,” it said.
“Although methylene blue products are only prescription-only when presented for injection, they are not without significant risks when used orally.”
Six deaths involving methylene blue have been reported to the TGA’s adverse event database, with four of those reports lodged this year, but it is not clear if the product was being used for wellness reasons.
The TGA encourages people to report even if there is only a very small chance that a therapeutic good was the cause of an adverse event.
Reports are entered into the databases without being confirmed or assessed, and may not be complete or accurate, and could be lodged some time after the death.
The Victorian Poisons Centre received seven calls about exposures to methylene blue for “wellness benefits” between January and the end of September.
This came after just one call for this reason for each of the three years prior, and none in 2020 and 2021.
Centre medical director Shaun Greene said there was no current evidence that methylene blue improved health or brain function in healthy individuals.
“Methylene blue can cause nausea, vomiting, abdominal pain, difficulty breathing and can harm cells within the blood stream,” Dr Greene said.
“Methylene blue can also interact with several commonly prescribed medications to produce serious adverse health effects.”
Dr Greene warned unregulated methylene blue products may contain high doses that were more likely to make people unwell.
“These products haven’t been evaluated for safety or strength, and people using them risk serious harm — especially if they’re already on other medicines or have underlying health conditions,” he said.
Between January 1 and October 10 this year, the Queensland Poisons Information Centre received seven calls related to methylene blue ingestion where access was likely linked to unapproved wellness purposes.
But between 2020 and 2024, it received only five calls for this reason.
Centre manager Carol Wylie said consuming unregistered or unapproved methylene blue could cause serious side effects including rapid heart rate, dizziness, confusion and skin discolouration.
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Originally published as Alarm over unregulated methylene blue use
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