The MHRA have introduced pack size restrictions, revised recommended ages for use, and new safety warnings for over-the-counter stimulant laxatives (orally and rectally administered).
Following a national safety review, including advice from expert advisory groups and an Expert Working Group, the Commission on Human Medicines (CHM) has recommended the MHRA introduce a package of measures to support the safe use of over-the-counter stimulant laxatives in the UK.
In their in-depth review of the benefits and risks of these medicines, CHM noted that stimulant laxatives have an acceptable safety profile, have been widely used for many years, and are generally used responsibly. However, CHM also considered evidence that stimulant laxatives are subject to misuse and overuse. Such cases mostly concern people with eating disorders, although misuse and overuse are likely to be under-reported (see data in Public Assessment Report). Occasional, serious reports of misuse and overdose have been received, including rare reports of fatalities.
Furthermore, CHM noted that current clinical guidance recommends that stimulant laxatives should not be used first-line for short-term constipation. CHM concluded that stimulant laxatives could continue to be available to patients to purchase, subject to a range of proportionate measures to reduce the risk of misuse and support correct use.
The advice for healthcare professionals is as follows:
Constipation treatment options:
- For constipation, manage underlying causes and advise adult patients on appropriate first-line dietary and lifestyle measures, such as increasing dietary fibre, fluid intake, and activity levels.
- Stimulant laxatives should only be used if other laxatives (bulk-forming and osmotic) are ineffective (as clinical guidance).
- Children younger than 12 years should not use stimulant laxatives without advice from a prescriber and clinical guidance should be followed.
Changes to availability
- Large packs of stimulant laxatives will no longer be available from general sale outlets, such as newsagents and supermarkets — smaller packs will continue to be available in these outlets for short-term, occasional constipation in adults.
- 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.
Advice to provide to patients
- Seek support from a doctor, nurse, or pharmacist for ongoing constipation, rather than self-medicating with laxatives in the long-term.
- If symptoms of constipation persist after dietary and lifestyle changes and short-term laxative treatment (under the advice of pharmacist), or in case of persistent abdominal pain or passing blood, consult a doctor.
- parents and caregivers should seek medical advice about constipation in children – children younger than 12 years should not use stimulant laxatives unless told to do so by their prescriber.
This circular is being shared under the Open Government Copyright licence.