WAGNER TURMERIC 3333 + (RF Six Pty Ltd)
Product Name
WAGNER TURMERIC 3333 +
Sponsor
Date of review outcome
Date of publication
Jun-2024
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health practitioner if you are or have been using this medicine to treat symptoms of irritable bowel syndrome as the medicine may not work as expected.
Consider whether this medicine is right for you given that claims for digestion, liver and gall bladder function, bile secretion and excretion, mild rheumatic pain, pain of mild osteoarthritis, menstrual pain (dysmenorrhea) and irregular periods (amenorrhea) were not substantiated by the sponsor.
Be aware that the medicine may also not work as expected in relation to the advertised claims for irritable bowel syndrome, inflammation, and joint swelling and stiffness associated with rheumatism.
Consider whether this medicine is right for you given that claims for digestion, liver and gall bladder function, bile secretion and excretion, mild rheumatic pain, pain of mild osteoarthritis, menstrual pain (dysmenorrhea) and irregular periods (amenorrhea) were not substantiated by the sponsor.
Be aware that the medicine may also not work as expected in relation to the advertised claims for irritable bowel syndrome, inflammation, and joint swelling and stiffness associated with rheumatism.
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
The website for this medicine refers to irritable bowel syndrome, which shares symptoms with more serious conditions that require diagnosis, treatment or supervision by a suitably qualified health practitioner.
The reference to irritable bowel syndrome without specifying 'medically diagnosed' is not permitted for medicines that are available for self-selection without prior evaluation by TGA. Consumers with symptoms of this syndrome who delay seeking timely medical advice or treatment, could experience adverse health outcomes.
However, this medicine's label and website advises consumers to consult a healthcare professional if symptoms persist, therefore this medicine is unlikely to pose an immediate risk to consumer health and safety.
The reference to irritable bowel syndrome without specifying 'medically diagnosed' is not permitted for medicines that are available for self-selection without prior evaluation by TGA. Consumers with symptoms of this syndrome who delay seeking timely medical advice or treatment, could experience adverse health outcomes.
However, this medicine's label and website advises consumers to consult a healthcare professional if symptoms persist, therefore this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The sponsor either did not hold evidence or the evidence provided was insufficient to support the claims detailed in 'What action should consumers take?' above.
The limitations with the evidence was that it described preparation methods for turmeric that differed from those used to prepare the medicine. Therefore, the health benefits described in the evidence are not relevant to the medicine.
The limitations with the evidence was that it described preparation methods for turmeric that differed from those used to prepare the medicine. Therefore, the health benefits described in the evidence are not relevant to the medicine.
Actions taken during the review
The TGA issued an educational letter to the sponsor for issues with their medicine.
The sponsor was not required to respond but was expected to correct the issues with the medicine, including those in relation to website advertising for irritable bowel syndrome.
The sponsor was not required to respond but was expected to correct the issues with the medicine, including those in relation to website advertising for irritable bowel syndrome.