Imported unregistered methylene blue products

The Therapeutic Goods Administration (TGA) is issuing a safety advisory about the increasing importation and use of unregistered oral methylene blue (methylthioninium chloride) products in Australia.

These products are being promoted for unapproved (off-label) uses, such as cognitive enhancement, mood improvement, and anti-ageing effects. They have not been assessed by us for quality, safety or efficacy as required under Australian legislation.

Although methylene blue products are only prescription-only when presented for injection, they are not without significant risks when used orally.

We advise consumers to exercise extreme caution when purchasing medicines from unknown overseas websites.

Products purchased over the internet:

• may be fake
• may contain incorrect or undisclosed and harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Most methylene blue products imported from online stores do not include clear instructions or warnings.

Key safety concerns:

• Risk of dangerous drug interactions
  • Medicines that affect serotonin levels such as some painkillers and selective serotonin reuptake inhibitors (SSRIs), a common type of antidepressant, can cause serotonin syndrome when taken with methylene blue.
  • Serotonin syndrome is a potentially life-threatening. Symptoms can include muscle spasms, sweating, tremor, confusion, and agitation.
• Risk during pregnancy
  • Methylene blue should not be used during pregnancy. It has been associated with birth defects in both humans and animals.
• Risk of blood disorders
  • People with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (a genetic condition) may experience red blood cell damage (haemolysis) if they take methylene blue.

Information for consumers

• Do not use oral methylene blue products unless advised or prescribed by a healthcare professional.
• Be aware of serious risks, including serotonin syndrome, birth defects, and haemolysis.
• Always consult your healthcare provider before using any imported or unregistered medicine.
• If you suspect you have had a side effect (also known as an adverse event) to this or a similar medicine, report it to the TGA.
• If you are considering purchasing medicines from overseas, watch this short video on the risks associated with buying medicines and medical devices online.
• If you have any concerns arising from your use of these or similar products, seek advice from your treating medical practitioner.

For your safety, always buy medicines from reputable sources and consult your healthcare provider or local registered pharmacy if you have any questions.

Information for health professionals

Health professionals also play a key role in identifying and managing the risks associated with unregistered methylene products. These include the potential for serotonin syndrome, risks during pregnancy and risks in patients with G6PD deficiency; patients should be advised accordingly.

Health professionals are encouraged to report adverse events involving medicines, including unapproved medicines. These reports assist the TGA in identifying previously unknown side effects and other safety issues.

Action we are taking

We will notify the Australian Border Force (ABF) to seize and destroy any of these products intercepted at the border that do not comply with import conditions.

Reporting problems

If you experience an adverse event you are encouraged to report it to the TGA as this helps us monitor and respond to emerging safety concerns.

If you suspect non-compliance in relation to therapeutic goods, you can report a perceived breach or questionable practice online to the TGA.