Based on its evaluation of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing mesalazine, the Pharmacovigilance Risk Assessment Committee (PRAC) reached the following conclusions.
Given the available data from spontaneous reports of urine discoloration and the plausible mechanism, the PRAC considers a causal relationship between the use of medicinal products containing mesalazine and urine discoloration after contact with sodium hypochlorite to be at least a reasonable possibility.
З огляду на наявні дані зі спонтанних повідомлень щодо виникнення індукованої лікарськими засобами еозинофілія з системними симптомами (DRESS-синдром), PRAC вважає причинно-наслідковий зв’язок між застосуванням лікарських засобів, що містять месалазин (mesalazine) та виникненням DRESS-синдрому є щонайменше можливим. PRAC дійшов висновку, що до інструкцій для медичного застосування лікарських засобів, які містять месалазин (mesalazine), слід внести відповідні зміни.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the scientific conclusions drawn by the PRAC.
Based on the scientific conclusions, the CMDh considers that the benefit/risk balance of medicinal products containing mesalazine remains unchanged, subject to the proposed changes to the product information.
Changes that should be included in the relevant sections of the instructions for medical use (new text underlined in bold, deleted text struck through).
Section “Special warnings and precautions for use”
The following warnings should be added:
Mesalazine may cause red-brown discoloration of urine after contact with sodium hypochlorite bleach (for example, in toilets cleaned with sodium hypochlorite contained in some bleaches)
Severe cutaneous adverse reactions
Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), associated with mesalazine treatment have been reported.
The use of mesalazine should be discontinued at the first appearance of signs and symptoms of serious cutaneous adverse reactions, such as skin rash, mucosal lesions or any other signs of hypersensitivity.
“Adverse reactions” section
Add to the subsection “Skin and subcutaneous tissue disorders” with the frequency “Unknown” the adverse reaction “drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)”
Summary of safety profiles
Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see the section "Special warnings and precautions for use").
List of medicinal products containing mesalazine (mesalazine) that are authorized for use in Ukraine (according to the State Register of Medicinal Products as of 01.12.2022) (15 KB) (Downloaded: 09.12.2022 13:03:16)
For the analysis of published information, the applicant must use the original text available at the link:
