BergaMet (DOJS Holdings Pty Ltd)
Product Name
BergaMet
Sponsor
ARTG
Date of review outcome
Date of publication
Sep-2024
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 medical practitioner if you are or have been taking this medicine for preventing or treating non-alcoholic fatty liver disease (NAFLD) and/or steatosis, increasing the breakdown of low-density lipoprotein (LDL) cholesterol, decreasing triglycerides cholesterol, reducing hepatic triglyceride accumulation, elevating hepatic lipid catabolic enzyme, and lowering levels of the liver enzymes alanine transaminase and aspartate transaminase. Consider whether this medicine is right for you based on it potentially not working as expected in relation to the conditions described above, as well as claims about traditional use as a liver and gallbladder remedy, liver regenerating effects, weight loss, decreasing 'blood stickiness', and improving glucose and lipid metabolism.
Review scope
Targeted
Information reviewed
ARTG Record, Website
Issues related to safety
The 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, the claims have been removed and the website advises consumers to see a doctor if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The 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 TGA required the sponsor to correct the issues with this medicine. The sponsor updated the website to remove the claims specified in 'What action should consumers take?'