Suppository for Hemorrhoid (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
Suppository for Hemorrhoid
ARTG
107592
Date of review outcome
Date of publication
Dec-19
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
No, continued use is not recommended as its safety is not considered acceptable for a listed medicine
What action should consumers take?
Stop using this medicine immediately and seek advice from a healthcare practitioner
Review scope
Targeted
Information reviewed
ARTG Record
Issues related to safety
The medicine contains a herbal ingredient (Datura stramonium) which is only allowed for use in listed medicines taken orally. However, this medicine is for rectal use. Additionally, the levels of this herbal ingredient are higher than that permitted for listed medicines. However, current data indicates that the amount of this ingredient contained in the medicine is unlikely to pose an immediate safety risk following rectal use.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
TGA required the sponsor to correct the issues with the product. The sponsor cancelled their medicine and withdrew it from further supply.