HYDRODOL Hangover Relief, Jumbo (Biorevive Pty Ltd)
Product Name
HYDRODOL Hangover Relief, Jumbo
Sponsor
ARTG
304289
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 related to hangover relief, liver support and traditional uses in Western herbal medicine in supporting healthy digestive system function and relieving symptoms associated with occasional overindulgence were not substantiated by the sponsor. Be aware that the medicine may also not work as expected in relation to Ayurvedic liver support, rehydration, traditional Chinese use, supporting alcohol metabolism and replacing and/or compensating for changes in body carbohydrates, amino acids and acid base buffers associated with alcohol intake.
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 labels and webpage 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 claims related to hangover relief, liver support and traditional uses in Western herbal medicine in supporting healthy digestive system function and relieving symptoms associated with occasional overindulgence.
The active ingredients, method of preparation for herbal active ingredients, dosages, duration and frequency of use described in the evidence were inconsistent with those for the medicine.
An unpublished clinical study was provided to support the hangover relief claim. The limitations of the evidence included lack of peer-review and declaration of conflicts of interest; reported effects on hangover were not clinically significant and possibly not due to the trial medicine alone; inadequately controlled variables (such as type of alcoholic beverages taken); and poor or unjustified relevance to the sponsor’s medicine (e.g. symptoms that showed significant differences were not commonly associated with hangover; the formulation, dosages and dosage regimens described in the study were different or not justified as being relevant to this medicine).
Symptoms and claims described in other pieces of evidence were not relevant or not justified to support the hangover relief claim.
Additionally, the labels and webpage of the medicine advertised claims related to Ayurvedic traditional use of Milk Thistle to support liver health, Chinese traditional use of Kudzu for tonic effects on the body, rehydration, use of vitamins, minerals, amino acids and herbs to restore balance and support alcohol metabolism, and the relief of hangover symptoms by replacing and/or compensating for the changes in body carbohydrates, amino acids and acid base buffers associated with alcohol intake. These claims were not covered by the sponsor’s certification that they held evidence to substantiate them.
The active ingredients, method of preparation for herbal active ingredients, dosages, duration and frequency of use described in the evidence were inconsistent with those for the medicine.
An unpublished clinical study was provided to support the hangover relief claim. The limitations of the evidence included lack of peer-review and declaration of conflicts of interest; reported effects on hangover were not clinically significant and possibly not due to the trial medicine alone; inadequately controlled variables (such as type of alcoholic beverages taken); and poor or unjustified relevance to the sponsor’s medicine (e.g. symptoms that showed significant differences were not commonly associated with hangover; the formulation, dosages and dosage regimens described in the study were different or not justified as being relevant to this medicine).
Symptoms and claims described in other pieces of evidence were not relevant or not justified to support the hangover relief claim.
Additionally, the labels and webpage of the medicine advertised claims related to Ayurvedic traditional use of Milk Thistle to support liver health, Chinese traditional use of Kudzu for tonic effects on the body, rehydration, use of vitamins, minerals, amino acids and herbs to restore balance and support alcohol metabolism, and the relief of hangover symptoms by replacing and/or compensating for the changes in body carbohydrates, amino acids and acid base buffers associated with alcohol intake. 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 the medicine and withdrew it from further supply. Nevertheless, TGA issued an educational letter to the sponsor outlining the issues with the medicine.
Additional information
This medicine was targeted to check its compliance in relation to hangover claims