Osteo-Restore (Interpath Pty Ltd)
Product Name
Osteo-Restore
Sponsor
ARTG
404738
Date of review outcome
Date of publication
Dec-2024
Outcome
Medicine is no longer permitted to be supplied
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 suitably qualified health practitioner if you are or have been taking this medicine for fracture prevention, bone restoration, broken bones, treatment or management of joint injuries, back injuries, arthritis, osteoarthritis, osteoporosis, or other degenerative diseases.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to strengthening of bones, reduction of pain including chronic back pain, improving joint mobility, and low bone density.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to strengthening of bones, reduction of pain including chronic back pain, improving joint mobility, and low bone density.
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 practitioner when required, which may result in adverse outcomes.
The website also contained claims that this medicine is safe or that its use has no side effects. These claims are not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even if it is not safe or appropriate for them.
While advertising of this nature is unacceptable, the label and website advised consumers to talk to their health professional if symptoms persist. In addition, the website has been removed. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The website also contained claims that this medicine is safe or that its use has no side effects. These claims are not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even if it is not safe or appropriate for them.
While advertising of this nature is unacceptable, the label and website advised consumers to talk to their health professional if symptoms persist. In addition, the website has been removed. As such, 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 removed the website. The sponsor cancelled this medicine and withdrew it from further supply.