Policosanol Active Power (Wigna Pharmaceuticals Pty Ltd)
Product Name
Policosanol Active Power
Sponsor
Date of review outcome
Date of publication
Dec-2024
Outcome
Medicine continues to be permitted for supply. Stock supplied after 25 September 2024 must carry a corrected label.
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 doctor if you are or have been using this medicine while at risk of, or to treat, conditions related to high blood cholesterol, high blood pressure/hypertension, heart disease and stroke, plaque in arteries, heart inflammation, circulation and leg discomfort in diabetics, age-related macular degeneration, and hearing loss.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the above conditions as well as lowering blood cholesterol levels and improving heart health, decreasing LDL cholesterol, increasing HDL cholesterol, decreasing blood pressure, improving eyesight, improving hearing, and leg discomfort.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the above conditions as well as lowering blood cholesterol levels and improving heart health, decreasing LDL cholesterol, increasing HDL cholesterol, decreasing blood pressure, improving eyesight, improving hearing, and leg discomfort.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label and 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.
While advertising of this nature is unacceptable, current data indicates that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, current data indicates that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and 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 labels and website to correct the issues.
The TGA issued an educational letter to the sponsor about potential issues with this medicine.
The TGA issued an educational letter to the sponsor about potential issues with this medicine.