Published: 27 June 2022
Consultations
Outcome of the consultation on the proposed warning and advisory statements relating to harm of long-term use and overuse of stimulant laxatives
Summary
- Medsafe sought comments on plans to introduce new labelling requirements for medicines containing stimulant laxatives.
- 21 responses to the consultation were received.
- Download the Consultation outcome document to view the consultation
feedback, Medsafe’s response and the finalised warning and advisory
statements:
Proposed warning and advisory statements relating to harm of long-term use and overuse of stimulant laxatives – Consultation outcome (PDF 262 MB, 20 pages) - The implementation date for the new statements will be 1 March 2024.
About the consultation
This Medsafe consultation proposed new warning and advisory statements for stimulant laxatives. The review of the statements arose from a recommendation of the Medicines Adverse Reactions Committee to minimise the misuse of stimulant laxatives in New Zealand.
The consultation opened on 29 September 2021 and closed on 11 November 2021.
More information about the consultation.
Submissions received
There were 21 responses to the consultation. Respondents included members of the public, healthcare professionals, industry, and professional bodies. Most respondents were supportive of the new warning and advisory statements.
You can view the submissions that we have permission to publish.
Medsafe would like to thank all those who took the time to respond to the consultation and provided comments.
Outcome
The information below is only a brief summary of the consultation outcomes. For the full consultation feedback and Medsafe’s response, please download the consultation outcome document.
- Proposed warning and advisory statements relating to harm of long-term use and overuse of stimulant laxatives – Consultation outcome (PDF 262 MB, 20 pages)
Based on respondent feedback, we have made some changes to our initial proposed statements – see the consultation outcome document for details.
Key changes are as follows.
- The proposed statement “Prolonged or excessive use can be harmful” has been revised to “Excessive use can be harmful”.
- The proposed statement “Consult a healthcare professional if symptoms persist” has been revised to “If symptoms persist seek medical advice”.
- The new warning and advisory statements do not apply to bowel cleansing preparations. This has been outlined in the conditions.
We note that medicines containing stimulant laxatives in New Zealand may already have Australian-required statements on the labels. In general, Australian statements may remain on New Zealand labels as long as they do not conflict with the New Zealand statements.
Implementation date
The proposed implementation date for the new warning and advisory statements was 12 months following the update of the Label Statements Database. However, based on feedback from industry, the implementation date has been revised to 18 months.
The Label Statements Database will be updated on 1 September 2022. Medicines released for supply in New Zealand after 1 March 2024 must have updated package labels that include the new warning and advisory statements. However, we encourage sponsors to update their labels before this date, if feasible.
We expect that all New Medicine Applications will comply with the updated labelling requirements unless we have agreed to alternative arrangements proposed by the sponsor.
Enquiries
Any questions relating to this consultation should be emailed to: medsafeapplications@health.govt.nz.
