The measures are being introduced following a national safety review prompted by concerns relating to misuse and abuse of stimulant laxatives in people with eating disorders, overuse in the elderly and use in children without medical supervision.
Patients should be advised that dietary and lifestyle measures should be used first-line for relieving short-term occasional constipation and that stimulant laxatives should only be used if these measures and other laxatives are ineffective, the MHRA says.
Stimulant laxatives available from general sales outlets such as newsagents and supermarkets will be indicated for the treatment of short-term, occasional constipation in adults only. Products available for general sale will be limited to a pack size of two short treatment courses (up to 20 standard-strength tablets, 10 maximum-strength tablets or 100ml solution/syrup).
Pharmacies will continue to hold larger packs of up to 100 tablets for use in adults and children aged 12 years or older, under the supervision of a pharmacist. Stimulant laxatives should no longer be used in children under 12 years without advice from a prescriber.
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 for stimulant laxatives will be standardised and will advise patients that overuse of stimulant laxatives may be harmful owing to the risk of fluid and electrolyte disturbances and potential disruption of intestinal function.
Dr Sarah Branch, Director of MHRA’s Vigilance and Risk Management of Medicines Division, said: 'Stimulant laxatives can provide short-term relief to some people with occasional constipation, and most people use these medicines safely. However, there is evidence of misuse by people with eating disorders, and of long-term use by the elderly, as well as inappropriate use in children.
'Patient safety is our highest priority. We believe these new measures are necessary to address the risks associated with misuse, while continuing to allow safe and appropriate access to these medicines without prescription to treat short-term constipation.'
Stimulant laxatives available in the UK over-the-counter are bisacodyl (eg, Dulcolax), senna and sennosides (eg, Senokot), and sodium picosulfate (eg, Dulcolax Pico).