VLC-Q (Proudex Australia Pty Ltd)
Product Name
VLC-Q
Sponsor
ARTG
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine continues to be permitted for supply. Batches released from 1 January 2021 must carry a corrected label with claims related to liver tonic removed and claims related to cholesterol health amended to only include healthy individuals.
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?
This medicine is not recommended for pregnant and lactating women. Seek advice from a suitably qualified health practitioner if you have been using this medicine and were/are pregnant or breastfeeding while taking it. This medicine contains tartrazine. Consider whether the medicine is right for you if you have allergies or sensitivities to this substance. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner. In addition, consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to being a liver tonic and supporting cholesterol health in individuals with health issues. Always read the label and follow the directions for use.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Website
Issues related to safety
The website of the medicine was missing the warning statement 'Not recommended for use by pregnant and lactating women’. As such, pregnant and breastfeeding women may not be alerted to the fact that this medicine is not recommended for them prior to taking the medicine, which may adversely affect their health.
Additionally, the medicine contains the ingredient tartrazine, which was not declared on the website. Tartrazine is a colorant that may cause adverse reactions in individuals with allergies or sensitivities to this substance. Thus, not declaring it on the website may lead to unsafe use of this medicine by people with allergy or sensitivity to tartrazine.
However, due to the presence of both of these warning statements on the label for the medicine, their absence on the website is unlikely to pose an immediate safety risk to consumers.
Additionally, the medicine contains the ingredient tartrazine, which was not declared on the website. Tartrazine is a colorant that may cause adverse reactions in individuals with allergies or sensitivities to this substance. Thus, not declaring it on the website may lead to unsafe use of this medicine by people with allergy or sensitivity to tartrazine.
However, due to the presence of both of these warning statements on the label for the medicine, their absence on the website is unlikely to pose an immediate safety risk to consumers.
Issues related to efficacy
The label, website and leaflet for the medicine claimed that the medicine is a liver tonic and may support cholesterol health in all individuals (healthy or with health issues). However, the liver tonic claim is not covered by the sponsor’s certification that they held evidence to substantiate them and the sponsor’s certification relating to cholesterol health only covers healthy individuals.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the labels, website and ARTG listing of the medicine to correct these issues.