Arthro-Calm (Aussie Tucker Technik Pty Ltd T/A IJ Contract Pharmaceuticals)
Product Name
Arthro-Calm
ARTG
Date of review outcome
Date of publication
Jun-2024
Outcome
Medicine continues to be permitted for supply. Batches released from 19 March 2024 must carry a corrected label.
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?
This medicine contains Green Lipped Mussel (Mollusc), which may cause allergic reactions in some people. If you develop a reaction, discontinue use, and consult a suitably qualified medical practitioner.
Seek advice from a medical practitioner if you are or have been taking this medicine to ease inflammation associated with rheumatoid arthritis, or to increase joint mobility associated with arthritis.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to easing inflammation associated with osteoarthritis, relieving rheumatic pain, and maintaining or improving general well-being.
Seek advice from a medical practitioner if you are or have been taking this medicine to ease inflammation associated with rheumatoid arthritis, or to increase joint mobility associated with arthritis.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to easing inflammation associated with osteoarthritis, relieving rheumatic pain, and maintaining or improving general well-being.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The labels for this medicine were missing the required warning statement for mollusc-derived ingredients. Mollusc-derived ingredients are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. However, the presentation of this medicine makes it clear to consumers that the medicine contains that ingredient.
The labels for this medicine made claims specified in 'What action should consumers take?' above. Some of these claims are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health practitioner when required, which may result in adverse outcomes. While advertising of this nature is unacceptable, the labels instruct consumers to consult a healthcare professional if symptoms persist.
As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The labels for this medicine made claims specified in 'What action should consumers take?' above. Some of these claims are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health practitioner when required, which may result in adverse outcomes. While advertising of this nature is unacceptable, the labels instruct consumers to consult a healthcare professional if symptoms persist.
As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The labels for this medicine contained claims specified in 'What action should consumers take?' above. 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 this medicine. The sponsor updated the labels to correct the issues.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to mollusc-derived ingredients