Hydrodol Powder (Before) (Biorevive Pty Ltd)
Product Name
Hydrodol Powder (Before)
Sponsor
ARTG
291421
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
What action should consumers take?
Consider whether this medicine is right for you as the claims related to hangover relief were not substantiated by the sponsor
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support claims related to hangover relief. The 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An unpublished clinical study was provided to support the hangover relief claim.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 a 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 indications described in other pieces of evidence were not relevant or not justified to support the hangover relief claim.
An unpublished clinical study was provided to support the hangover relief claim. The limitations of the evidence included a 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 indications described in other pieces of evidence were not relevant or not justified to support the hangover relief claim.
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