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.
Given the available data from spontaneous reports on the occurrence of drug-induced eosinophilia with systemic symptoms (DRESS syndrome), PRAC considers a causal relationship between the use of medicinal products containing mesalazine and the occurrence of DRESS syndrome to be at least possible. PRAC concluded that the instructions for medical use of medicinal products containing mesalazine should be amended accordingly.
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").
Перелік лікарських засобів, що містять месалазин (mesalazine) та дозволені для застосування на території України (за даними Державного реєстру лікарських засобів станом на 01.12.2022)
For the analysis of published information, the applicant must use the original text available at the link:
