Emu Tracks Emu Oil (Emu Tracks Australasia Pty Ltd)
Product Name
Emu Tracks Emu Oil
Sponsor
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, however, use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
The medicine contains sulfites. Consider whether the medicine is right for you if you have allergies or sensitivities to sulfites. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
In addition, seek advice from a suitably qualified health professional if you are or have been taking this medicine to treat rheumatoid arthritis, chronic or severe conditions, digestive disorders, irritable bowel syndrome, Crohn’s disease, ulcers, depression, mood disorders, cardiovascular disease, osteoarthritis, arthritic conditions or lowering cholesterol levels.
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to the above conditions as well as joint pain, muscular aches, bruising, sprains, strains, inflammation and indigestion.
In addition, seek advice from a suitably qualified health professional if you are or have been taking this medicine to treat rheumatoid arthritis, chronic or severe conditions, digestive disorders, irritable bowel syndrome, Crohn’s disease, ulcers, depression, mood disorders, cardiovascular disease, osteoarthritis, arthritic conditions or lowering cholesterol levels.
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to the above conditions as well as joint pain, muscular aches, bruising, sprains, strains, inflammation and indigestion.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label did not include the mandatory declaration for 'sulfites’. Sulfites 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. Whilst the undeclared presence of trace amounts of sulfites may pose a safety risk for some consumers, current data suggest that severe adverse reactions due to trace residue of sulfites (such as anaphylaxis) are rare. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Additionally, the label and website for the medicine advertised its use in rheumatoid arthritis, chronic or severe conditions, digestive disorders, irritable bowel syndrome, Crohn’s disease, ulcers, depression, mood disorders, cardiovascular disease, osteoarthritis, arthritic conditions and lowering cholesterol levels which are serious conditions that require diagnosis, treatment 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. References to these conditions have the potential to lead consumers to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, the label of the medicine also warned 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.
Additionally, the label and website for the medicine advertised its use in rheumatoid arthritis, chronic or severe conditions, digestive disorders, irritable bowel syndrome, Crohn’s disease, ulcers, depression, mood disorders, cardiovascular disease, osteoarthritis, arthritic conditions and lowering cholesterol levels which are serious conditions that require diagnosis, treatment 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. References to these conditions have the potential to lead consumers to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, the label of the medicine also warned 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 label and website for the medicine claimed that the medicine may help with the conditions listed in 'what actions should consumers take’ section. 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 label and the website of the medicine to correct these issues.