Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Liver Health Complex (D & X Pty Ltd)
Product Name
Liver Health Complex
Sponsor
ARTG
270272
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Consider whether the medicine is right for you given that claims about reducing free radical damage to body cells, assisting in the relief of nausea and flatulence, helping to relieve minor digestive disturbances including lack of appetite, providing liver protection and assisting in the symptomatic relief from hangover and headaches, were not substantiated by the sponsor. Be aware that the medicine may also not work as expected in relation to supporting normal/healthy liver function and increasing bile flow.
Be aware that consumption of this medicine is not a substitute for responsible drinking or for reducing the consumption of alcohol.
Be aware that consumption of this medicine is not a substitute for responsible drinking or for reducing the consumption of alcohol.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The label and website for the medicine may promote its use as a substitute for responsible drinking, which is inconsistent with the public health campaigns about the responsible drinking of alcohol and that minimising alcohol intake is the best way of reducing alcohol-related harm. While advertising of this nature is unacceptable, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the unsubstantiated claims detailed in ‘What action should consumers take?’ above. The dosages, standardisation and method of preparation of ingredients in the evidence provided were inconsistent with the medicine. Some sources of evidence used were not of sufficient quality.
The website claimed that the medicine supported liver health and function and may be used as a diuretic to increase bile flow. These claims were not covered by the sponsor’s certification that they held evidence to substantiate them.
The website claimed that the medicine supported liver health and function and may be used as a diuretic to increase bile flow. 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 cancelled the medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check its compliance in relation to hangover claims