Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
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:
Changes to availability
Advice to provide to patients
This circular is being shared under the Open Government Copyright licence.
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.