Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

Consultation Letter ARM 42: Request to Reclassify a Product from P to GSL - Imodium Capsules and Imodium Instants

Deadline for response:

13 July 2007

Background: Imodium Capsules are licensed as POM, P and GSL packs. The P product is indicated for the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome (IBS) in adults following initial diagnosis by a doctor. The P and GSL products are both indicated ‘for the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over’.

Imodium Instants are a GSL product which are indicated ‘for the symptomatic treatment of acute diarrhoea’.

It is proposed that the indication ‘for the symptomatic treatment of acute episodes of diarrhoea associated with IBS in adults aged 18 years and over following initial diagnosis by a doctor’ be added to both licences.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY CONSULTATION LETTER ARM 42: REQUEST TO RECLASSIFY A PRODUCT FROM P TO GSL - IMODIUM CAPSULES AND IMODIUM INSTANTS

The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on Consultation Letter ARM 42. 

The proposal is that Imodium Capsules and Imodium Instants should be reclassified from P to GSL “for the symptomatic treatment of acute episodes of diarrhoea associated with IBS in adults aged 18 years and over following initial diagnosis by a doctor”.  The symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over already has a GSL licence for these products.

This does not appear to be a controversial proposal.  Loperamide, although a synthetic opioid, is largely bound to opiate receptors in the gut wall.  It also has a high first-pass metabolism.  It therefore has a good safety profile with few adverse effects reported over the years.  The concern may be that patients would self-medicate symptoms which might represent serious underlying conditions such as malignancy, bacterial enterocolitis or acute dysentery.  However, the change in the licence would not increase this potential risk, which already exists with its prescribing in acute diarrhoea.  The Patient Information Leaflet makes these potential concerns very clear and indicates the limits to which patients with IBS should treat diarrhoea with this product, and when they should consult with their doctors.

In these circumstances, the College therefore supports this proposal.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[25 June 2007]