Khapregesic (Bioactive Laboratories Pty Ltd)
Product Name
Khapregesic
Sponsor
Date of review outcome
Date of publication
Jun-23
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Be aware that this medicine is not permitted by the TGA to treat, prevent or relieve symptoms of endometriosis, poly-cystic ovary syndrome, adenomyosis, anxiety and arthritis. Seek advice from a suitably qualified health professional if you have been or are intending on using this medicine for these purposes.
Consider whether this medicine is right for you based on this medicine potentially not working as expected in relation to sleep, joint pain, vitality, post-menopause, libido, osteoarthritis, focus and muscle recovery.
Review scope
Targeted
Information reviewed
ARTG Record, Website
Issues related to safety
The website for this medicine contained claims specified in the first paragraph of 'What action should consumers take?' above. These are serious conditions that require 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. These claims have the potential to lead consumers with these conditions to delay access to timely medical advice or treatment resulting in adverse outcomes.
The website also contained claims that other medicines, including over-the-counter painkillers and prescription medicines, are harmful. Implying that this medicine can be used for serious forms of a disease and negative comparisons to other medicines has the potential to lead consumers to delay access to timely medical advice or failing to use prescribed or recommended treatment, resulting in adverse outcomes.
The website contained endorsements of this medicine by health professionals and claims that it was approved by the TGA as safe. Endorsements by health professionals and government authorities are not permitted as they are likely to influence consumers to use a medicine even if it is not appropriate for them.
While advertising of this nature is unacceptable, the website advised consumers to see a health professional if symptoms persisted, and these claims have been removed from the website. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The website also contained claims that other medicines, including over-the-counter painkillers and prescription medicines, are harmful. Implying that this medicine can be used for serious forms of a disease and negative comparisons to other medicines has the potential to lead consumers to delay access to timely medical advice or failing to use prescribed or recommended treatment, resulting in adverse outcomes.
The website contained endorsements of this medicine by health professionals and claims that it was approved by the TGA as safe. Endorsements by health professionals and government authorities are not permitted as they are likely to influence consumers to use a medicine even if it is not appropriate for them.
While advertising of this nature is unacceptable, the website advised consumers to see a health professional if symptoms persisted, and these claims have been removed from the website. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The 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's website. The sponsor updated the website to remove the unsupported claims.