Natural Laxative with Prebiotic (Orchard Manufacturing Co Pty Ltd)
Product Name
Natural Laxative with Prebiotic
Sponsor
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health professional if you are or have been using this medicine to treat or relieve gastrointestinal inflammation.
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to soothing the digestive system.
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to soothing the digestive system.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The website of the medicine claimed that the medicine can relieve gastrointestinal inflammation. Gastrointestinal inflammation can be a serious condition that requires diagnosis, treatment or supervision by a suitably qualified health professional. Reference to gastrointestinal inflammation without specifying mild forms of the condition is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to this condition has the potential to lead consumers with inflammation to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the website also warns consumers to see a healthcare practitioner 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 the medicine relieves gastrointestinal inflammation and soothes the digestive system. However, these claims were not covered by the sponsors 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 removed the claims about relieving gastrointestinal inflammation and soothing the digestive system from the website.