New Measures for the Safety Use of Stimulant laxatives

Stimulant laxatives are medicines used in the treatment of constipation (infrequent bowel moments). These class of medicines stimulates intestinal motility by promoting secretion of water into the bowel which in turn facilitates bowel movements.

The OTC medicines available in the UK market are bisacodyl (such as Dulcolax), senna and sennosides (isolated, as calcium salts, such as Senokot), and sodium picosulfate (such as Dulcolax Pico).

Stimulant laxatives are not first line treatment option for short term constipation:

Dietary changes and lifestyle measures should be considered as first-line treatment option for relieving short-term occasional constipation. It is recommended that stimulant laxatives should not be used as first-line for short-term constipation, and they should be used only if the first line measures and other laxatives are not effective.

Bulk-forming laxatives can used as first line agents for constipation which included ispaghula husk or methylcelluloseor sterculia, followed by an osmotic laxative which included lactulose or macrogols (Movicol, CosmoCol and Laxido) in addition to, or instead of, a bulk-forming laxative.

When both bulk forming and osmotic laxatives were found ineffective, then a stimulant laxative might be added in addition to a bulk-forming laxative. All of these laxatives are available as over-the-counter (OTC) medicines and should only be taken occasionally.

Drug Misuse & Abuse:

The national health authority of UK, Medicines and Healthcare products Regulatory Agency (MHRA), completed a review on the safety of stimulant laxatives with respect to the concerns related to drug misuse and drug abuse. Expert working group from Commission on Human Medicines (CHM) identified safety evidence pertaining to the misuse and overuse which are likely to be under reported (no adequate voluntary reporting of ADRs associated with misuse and abuse of stimulant laxatives). MHRA received some occasional serious case reports of misuse and overdose which included fatal reports (death cases).

MHRA has released following safety information which are the new measures for minimizing the anticipated risks (drug misuse and abuse) and promoting the safe use of stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) which are available as OTC medicines in UK market.

  1. Pack size restrictions:

MHRA restricted the pack size of stimulant laxative products to a limited pack size of two short treatment courses (upto 20 standard-strength tablets, 10 maximum-strength tablets or 100 ml solution/syrup).

  1. Restricted usage to paediatric population:

Use of stimulant laxatives are recommended for only adult or older population from general sale and can be made available to children only under pharmacist supervision.

  1. Harmonization of indications and new safety warnings

Removal of self-care setting in chronic constipation: Stimulant laxatives which are required regularly for long-term use in chronic constipation and for therapeutic indications such as clearance of bowel before a surgical procedure which are available only as prescription products.

Warnings:  Inclusion of advice to patients in the patient information leaflets for these medicines that ‘overuse of stimulant laxatives could cause harmful effects which included- risk of fluid and electrolyte disturbances and potential disruption in the functioning of intestine.

This safety information which included warnings and restricted usage based on age would be added to packaging portion of these medicines to stimulate and support awareness.

Voluntary ADR Reporting

Health care professionals (HCP) & consumers of pharmaceutical medicinal product(s) are strongly advised to be observe, become aware of the possible unusual experiences or adverse events after administration of medicinal product (s) and report those suspected adverse events or adverse drug reactions to MHRA via the Yellow Card Scheme.

This would help in early identification of potential signals and risks of medicinal product which are not yet detected by pharmaceutical companies or regulatory authorities.

Increased reporting of direct adverse drug event reports from the Public (either from consumers or HCPs) would foster the Pharmacovigilance activities of medicinal products which promotes a better patient safety and public health.

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