Gluten Rescue (Miasca Investments Pty Ltd)
Product Name
Gluten Rescue
Sponsor
ARTG
345565
Date of review outcome
Date of publication
Mar-2024
Outcome
Medicine is no longer permitted to be supplied
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?
Do not take this medicine because it is past its expiry date.
Seek advice from a medical practitioner if you have been taking this medicine to treat conditions related to gluten allergy/sensitivity (such as anaphylaxis, coeliac disease and dermatitis herpetiformis), mental illnesses (such as mood disorder, anxiety disorder, any other mental health disorder), chronic inflammation, behavioural issues, autism, arthritis, hormonal imbalances, infertility, autoimmune conditions, digestive disorders, neurodevelopmental disorder, parasites, infections and leaky gut.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the above conditions as well as diarrhoea, constipation, fatigue, lethargy, poor immune system, poor sleep, brain fog, eczema, dermatitis, acne, and headaches.
Seek advice from a medical practitioner if you have been taking this medicine to treat conditions related to gluten allergy/sensitivity (such as anaphylaxis, coeliac disease and dermatitis herpetiformis), mental illnesses (such as mood disorder, anxiety disorder, any other mental health disorder), chronic inflammation, behavioural issues, autism, arthritis, hormonal imbalances, infertility, autoimmune conditions, digestive disorders, neurodevelopmental disorder, parasites, infections and leaky gut.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the above conditions as well as diarrhoea, constipation, fatigue, lethargy, poor immune system, poor sleep, brain fog, eczema, dermatitis, acne, and headaches.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The name and website for this medicine contained 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 professional when required, which may result in adverse outcomes.
However, supply of this medicine ceased in August 2021 and the last batch of this medicine expired in February 2023. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
However, supply of this medicine ceased in August 2021 and the last batch of this medicine expired in February 2023. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name and website 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 sponsor cancelled this medicine after receiving the TGA's request for information. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.