Cefoperazone — Scientific Conclusions and Basis for Modification of Registration Approval Terms — PSUSA-00000597-202101 (Hematuria)


In view of the available data on coagulopathy and bleeding from clinical trials, literature, spontaneous reports, and given a plausible mechanism of action, PRAC believes a causal relationship between cefoperazone and hematuria to be at least reasonably possible. PRAC concluded that information about products containing cefoperazone should be changed accordingly. data source and details