Proposed warning and advisory statements relating to the harm of long-term use and overuse of stimulant laxatives

Closes 8 Nov 2021

Opened 27 Sep 2021

Overview

This Medsafe consultation proposes warning and advisory statements for stimulant laxatives.

Stimulant laxatives are either general sale or pharmacy-only medicines. This means these medicines can sometimes be purchased without advice from a healthcare professional. It also means there is no requirement for these medicines to have a data sheet or consumer medicine information leaflet. Consumers may therefore be unaware of the harm associated with long-term use or overuse of stimulant laxatives when purchasing these medicines.

In June 2021, the Medicines Adverse Reactions Committee recommended that Medsafe undertake a Label Statements Database consultation to include warning and advisory statements for all stimulant laxatives. The minutes of the meeting can be found here.

The Label Statements Database, published on the Medsafe website, lists the warning and advisory statements that are required on medicines and related package labelling. Currently there is no requirement for warning and advisory statements for stimulant laxatives. The current information related to harm on the package labelling of stimulant laxatives is variable.

Table 1 below shows the proposed warning and advisory statements for stimulant laxatives.

Table 1: Proposed warning and advisory statements for stimulant laxatives

Medicine/Group/Class Conditions Statement Required by
Stimulant laxatives
Examples include:
  • Biscodyl
  • Glycerol
  • Sennosides
  • Sodium picosulfate

When for oral or rectal use (except glycerol for rectal use only)

  • Does not help with weight loss
  • Prolonged or excessive use can be harmful
  • Consult a healthcare professional if symptoms persist
12 months from when the Label Statements Database is updated

 

Medsafe is seeking your comments on:

  • whether the package labelling for stimulant laxatives should include warning and advisory statements relating to the harm of long-term use and overuse
  • the proposed wording of the statements (see Table 1)
  • whether there are any other statements relating to the harm of long-term use and overuse of stimulant laxatives that should be included on the package labelling.

Note that if these proposed statements are added to the Label Statements Database, words of a similar meaning to the statements may be used and individual statements may be combined, provided the intent is not changed.

To assist in the analysis of submissions, Medsafe will only accept submissions made through this consultation website. However, the full consultation document is attached below as a PDF, and it can be viewed online, downloaded and/or printed.

Give us your views

Audiences

  • Members of the public
  • Health sector
  • Pharmaceutical companies

Interests

  • Therapeutic products