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module menu icon MHRA restrictions on access to stimulant laxatives

In August 2020, following a safety review, the MHRA introduced measures to support the safer use of OTC stimulant laxatives. Alongside these, advice was given on managing constipation and following the Clinical Knowledge Summaries guidance on constipation in adults. The licensing changes can be summarised as follows:

  • The indication for stimulant laxatives (senna and sennosides; bisacodyl and sodium picosulfate) is now for the short-term relief of occasional constipation
  • Children younger than 12 years with constipation should not be given stimulant laxatives (they must not be supplied) and must be medically assessed
  • Large packs of stimulant laxatives (such as 60 or 100 unit doses) are no longer available from GSL outlets, such as newsagents and supermarkets. Smaller packs are available for treating short-term, occasional constipation, for use in adults only. These are limited to a pack size of two short treatment courses (up to 20 standard-strength tablets, 10 maximum-strength tablets or 100ml solution/syrup) and recommended only for those 18 years or older
  • Pharmacies will continue to hold larger packs of up to 100 tablets of stimulant laxatives for use in adults (18 years and over) and children aged 12 years or older, under the supervision of a pharmacist. The MHRA and RPS have produced a pharmacy guide to support this guidance
  • Where stimulant laxatives are required regularly for longer-term use in chronic constipation or for indications not appropriate for the self-care setting, such as bowel clearance before surgery, they will be available as prescription-only products
  • Warnings in the patient information leaflets that accompany these medicines will be made consistent and advise patients that overuse of stimulant laxatives may be harmful due to the risk of fluid and electrolyte disturbances and potential disruption of intestinal function
  • Warnings are also being added to packaging to raise awareness of overuse. They now stipulate that laxatives should not be used to aid weight loss. The product information also now includes the new recommendations about age of use.