In 2025, we conducted targeted compliance reviews on selected listed medicines that include indications related to diarrhoea and are subject to specific warning statements. The targeted indications were:
- Decrease/reduce loose stools
- Decrease/reduce/relieve diarrhoea
- Helps decrease/reduce/relieve symptoms of traveller's diarrhoea
- Helps reduce occurrence of diarrhoea
- Helps reduce occurrence of symptoms of traveller's diarrhoea
- Atisara hara/ease diarrhoea
What led to this review?
Listed medicines must only use indications drawn exclusively from a list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. Medicines that contain the abovementioned indications are required to display the following warning statement:
- ‘Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).’
This project assessed whether the targeted medicines displayed the required warning statement. The absence of the required warning statement may result in consumers not seeking appropriate medical advice in a timely manner, leading to adverse health outcomes.
What we did
Fifteen listed medicines that contained the abovementioned indications were identified for review. We asked the sponsors of these medicines to provide the labels and websites for the medicines to check the presence of the required warning statements.
What we found
The sponsors of all 15 medicines (100%) responded to the TGA’s request for information, of which 14 medicines (93%) were found to comply with the required warning statement.
One medicine (7%) was found to be missing the required warning statement:
- The sponsor updated the label of the medicine so that it could remain on the ARTG.
The compliance review results for each medicine are published on the page Listed medicine compliance reports.
Information for sponsors
To support ongoing compliance, sponsors should take the following actions:
- review the indications used for your medicine to ensure that any requirements and warning statements mandated by the Therapeutic Goods (Permissible Indications) Determination are complied with
- be aware that missing warning statements on medicine labels may result in market action of non-compliant stock
- be aware that the requirements for indications in the Therapeutic Goods (Permissible Indications) Determination can change from time to time. It is the sponsor’s responsibility to make sure that these changes are implemented across their medicine(s) and
- be aware that repeatedly failing to comply with legislative requirements, such as not including the required warning statements on the label, could result in higher-level enforcement actions, including infringement notices or other penalties.