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Microgenics Glucosamine & MSM (RF Six Pty Ltd)
Product Name
Microgenics Glucosamine & MSM
Sponsor
Date of review outcome
Date of publication
Dec-21
Outcome
Medicine continues to be permitted for supply. Batches manufactured from 1 September 2021 must carry a corrected label.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Seek advice from a suitably qualified health professional if you are or have been taking this medicine to treat or relieve pain associated with arthritis, osteoarthritis, or rheumatoid arthritis. Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to maintaining joint stability, improving joint mobility, relieving joint inflammation, reducing collagen breakdown, or reducing wear and tear of the joint cartilage/tissue.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website of the medicine implied it can relieve arthritis, osteoarthritis and rheumatoid arthritis (or associated pain), which are serious conditions that require diagnosis, treatment and/or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The references to arthritis, osteoarthritis and rheumatoid arthritis have the potential to lead consumers with these conditions to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the label also warns consumers to see a healthcare professional if symptoms persist. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website of the medicine claimed that it may maintain joint stability, improve joint mobility, relieve joint inflammation, reduce collagen breakdown, and reduce wear and tear of the joint cartilage/tissue. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the website of the medicine to remove the claims that referred to serious forms of diseases/conditions and those claims that were not included in the ARTG Record.