The Medicines and Healthcare products Regulatory Agency (MHRA) have introduced pack size restrictions, age warnings and new safety warnings on labelling of over-the-counter (OTC) stimulant laxatives such as bisacodyl and senna.
Following an evidence-based national safety review and Public Assessment Report (PAR), new risk minimisation measures have been put into place for these medicines which are commonly used for the treatment of constipation, to help safeguard public health.
“Misusing laxatives can have a serious impact on the health of patients and the new risk minimisation measures will improve patient safety” according to the President of the Royal Pharmaceutical Society.
The review, by the Commission on Human Medicines (CHM), was prompted by concerns regarding the overuse and misuse of stimulant laxatives by patients with eating disorders, and overuse in the elderly and children without medical supervision.
Additional warnings will be added to the product labelling regarding the risk of overuse. They will clarify that these products do not help in weight loss. The new guidelines restrict the use of stimulant laxatives sold in retail outlets to patients over the age of 18. Only pharmacists will be able to sell stimulant laxatives for use in children aged 12 and over.
Anyone experiencing a side effect through use of a stimulant laxative, should report this to the MHRA through the Yellow Card scheme.
To view the PAR, click here.