Mesalazine treatment and urinary stones

The Netherlands Pharmacovigilance Centre Lareb received two reports of urinary stones when using the drug mesalazine. The compositions of the stones were not reported. Analysis of reports from other countries showed that during the use of mesalazine, urinary stones composed of mesalazine may form. 

Mesalazine reduces inflammation in the intestinal wall. It is prescribed for the chronic inflammatory bowel diseases Ulcerative colitis and Crohn’s disease. Urinary stones may occur through crystallization of various substances, as complication in inflammatory bowel disease or as malabsorption of substances from the intestines. 

In Europe, there were dozens of reports of urinary stones when using the drug mesalazine. In most of these reports, the compositions of the stones were not reported. Therefore, in these reports, it was not clear what caused the urinary stones. But in four reports it was reported that the stones were analysed and contained the drug mesalazine. In two of these reports, it was reported that the stones were for 100% composed of mesalazine. 

The Dutch Medicines Evaluation Board (CBG-MEB) will therefore propose to monitor the adverse reaction urinary stones closely in the next periodic safety update report (PSUR) of mesalazine. 

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