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module menu icon Licensing changes in 2020

Overuse of laxatives can result in a vicious cycle where the contents of the gut are expelled, causing a subsequent cessation of bowel actions for one or two days. This can then lead to the false conclusion that constipation has recurred and so more laxatives may be taken. 

Concern about overuse of laxatives led the MHRA, in August 2020, to introduce a package of measures to support the safer use of OTC stimulant laxatives. 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 and need to be medically assessed
  • Large packs of stimulant laxatives (e.g. 60s or 100s) are no longer available from GSL outlets such as newsagents and supermarkets. Smaller packs are available for the treatment of 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 aged 18 years or older
  • Pharmacies will continue to hold larger packs of up to 100 tablets of stimulant laxatives for use in adults aged 18 years and over and children aged 12 years or older, under the supervision of a pharmacist
  • 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 now also includes the new age recommendations.