TCM Prostate Support - [Niao Sai Tong Jiao Nang] (Cathay Herbal Laboratories)
Product Name
TCM Prostate Support - [Niao Sai Tong Jiao Nang]
Sponsor
ARTG
140501
Date of review outcome
Date of publication
Sep-2023
Outcome
Medicine is no longer permitted to be supplied and has been recalled by the sponsor
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?
Use in children under 12 years is not recommended. Do not use while breastfeeding. Seek advice from a suitably qualified health practitioner if you have been taking this medicine under these circumstances. For further instructions, please go to the safety alerts page on the TGA website (https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00057-1).
Seek advice from a health practitioner if you have been taking this medicine for the management of medically diagnosed benign prostatic hypertrophy.
Seek advice from a health practitioner if you have been taking this medicine for the management of medically diagnosed benign prostatic hypertrophy.
Review scope
Targeted (See Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for this medicine was missing two of the mandatory warning statements for the herbal ingredient Foeniculum vulgare, as set out under 'What action should consumers take?' above. These warning statements are necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking it.
Additionally, the label for this medicine made claims relating to benign prostatic hypertrophy, which is 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 suitability qualified health professional when required, which may result in adverse outcomes.
However, all batches of this medicine were recalled and are therefore unlikely to pose a safety risk to consumers.
Additionally, the label for this medicine made claims relating to benign prostatic hypertrophy, which is 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 suitability qualified health professional when required, which may result in adverse outcomes.
However, all batches of this medicine were recalled and are therefore unlikely to pose a safety risk to consumers.
Issues related to efficacy
The label for this medicine contained claims in relation to the management of medically diagnosed benign prostatic hypertrophy. However, this claim was not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The sponsor recalled all batches of this medicine from the market, cancelled this medicine, and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to fennel ingredients