PHARMACY CARE WILD KRILL 1000 MG (Sigma Company Limited)
Product Name
PHARMACY CARE WILD KRILL 1000 MG
Sponsor
ARTG
213191
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine continues to be permitted for supply. Batches released from 31 August 2020 must carry a corrected label with claims related to maintaining normal cholesterol levels, reducing the oxidation of LDL (bad) cholesterol and relief of arthritis removed.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Seek advice from a suitably qualified health professional if you are or have been taking this medicine to relieve arthritis. Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to maintaining normal cholesterol levels and reducing the oxidation of LDL (bad) cholesterol.
Review scope
Targeted (for presence of seafood warning)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label and website of the medicine imply it can relieve arthritis, which is a serious condition that requires diagnosis, treatment or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to arthritis has the potential to lead consumers with this condition to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the label also warns consumers to see a healthcare professional if symptoms persist. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and website claimed that the medicine may help to maintain normal cholesterol levels, reduce the oxidation of LDL (bad) cholesterol and relieve arthritis. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor removed the claims related to maintaining normal cholesterol levels, reducing the oxidation of LDL (bad) cholesterol and relief of arthritis from the medicine label and website.