Regarding amendments to the instructions for medical use of medicinal products containing mesalazine

Based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing mesalazine, the Pharmacovigilance Risk Assessment Committee (PRAC) made the following conclusions:

In view of the available data from the literature and spontaneous reports on severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, with the use of mesalazine, which had a close temporal relationship and positive dechallenge after withdrawal of medicinal products containing mesalazine, and in view of the likely mechanism of action, the PRAC lead country considers a causal relationship between mesalazine and the development of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, to be probable. PRAC recommends that registration certificate holders of medicinal products containing mesalazine amend the following sections of the instructions for medical use:

• "Adverse reactions" – regarding severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, with a frequency of "not known";
• “Special warnings and precautions for use” – regarding the warning in the subsection “Severe cutaneous adverse reactions”: severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with mesalazine. Mesalazine should be discontinued at the first signs and symptoms of severe skin reactions, such as skin rash, intestinal mucosal lesions, or any other signs of hypersensitivity.

The CMDh agrees with the scientific conclusions of the PRAC.

Linkhttps://www.ema.europa.eu/en/documents/psusa/mesalazine-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00001990/202002_en.pdf