Authors' response to Hermann et al. Minimum quality criteria are needed in the assessment and communication of unexpected drug safety findings of marketed products from RCTs

Abstract

Hermann et al. [1] suggest that minimum quality criteria are needed to communicate unexpected drug safety findings from randomized clinical trials and imply that our report on unexpected frequent hepatotoxicity in patients receiving flupirtine for the treatment of overactive bladder syndrome [2] does not meet such criteria. As the brief report format of our paper did not allow an extensive description of trial details, we welcome this opportunity to shed more light on the matter.