FOI release

Freedom of Information request on the Adverse Drug Reaction reports from 2012 to present regarding colesevelam and crystal deposits in the bowel (FOI 22/825)

Published 4 January 2024

FOI 22/825

25th July 2022

Dear

Please accept my apologies for the delay in responding to you. Thank you for your FOI request dated 27th May 2021, where you requested the following information:

• The number of reports in each calendar year from 2012 to present of instances involving uses of colesevelam and crystal deposits in the lining of the bowel and/or perforation of the bowel.

• An indication of the geographical areas (such as health board areas) wherein such reports were made.

I can confirm that the MHRA has not received any UK spontaneous suspected Adverse Drug Reaction (ADR) reports concerning colesevelam and relevant terms related to your request (including crystal deposit intestine, gastrointestinal perforation, intestinal perforation, lower gastrointestinal perforation, neonatal intestinal perforation, procedural intestinal perforation, small intestinal perforation, upper gastrointestinal perforation) up to and including 19th July 2022.

With regards to your second request, as no ADR reports were identified, we are therefore unable to provide further information regarding corresponding geographical areas.

You may be interested to hear about the interactive Drug Analysis Profiles (iDAPs) available on the Yellow Card website. For suspected side effects being reported, the MHRA publishes this information in the form of iDAPs which can be accessed using the link above. There is an iDAP for each licensed medicine by drug substance. Within an iDAP you can see all suspected side effects, known as suspected adverse drug reactions, that are reported to the MHRA.

When considering the spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:

• A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the medicine or vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to the medication or vaccination can

also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different medicines or vaccines.

• All reports are kept under continual review in order to identify possible new risks. For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people take medicines and vaccines without having any serious side effects.

• Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

The information from the iDAPs should not be interpreted as a list of known side effects of the medicinal product. The recognised side effects of a licensed medicinal product can be found in the product information which consists of the Summary of Product Characteristics (SPC) for healthcare professionals and the Patient Information Leaflet (PIL) which accompanies all medicines. The product information for colesevelam can be found at the following link:

Find product information about medicines - GOV.UK (www.gov.uk)

I hope that you will find this information useful.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division