Original Articles
Post-marketing surveillance on the usefulness of ZOSYN® for the treatment of febrile neutropenia in children: Results of a special drug use-results survey
2020 Volume 73 Issue 4 Pages 103-113
Details
2020 Volume 73 Issue 4 Pages 103-113
In June 2015, febrile neutropenia was approved as an additional indication for tazobactam/piperacillin (ZOSYN®). A special drug use-results survey was performed between August 2015 and July 2018 to investigate the clinical safety and efficacy of this drug in children with febrile neutropenia. A total of 142 patients from 48 institutions were enrolled in the study; safety and efficacy assessments were performed on 136 and 117 patients, respectively.
Among the 136 patients, adverse drug reactions (ADRs) were found in 23 patients (30 cases), with an incidence rate of ADRs being 16.9% (23/136 patients). None of the ADRs were serious. ADRs occurring in two or more patients included diarrhea (20 patients) and hepatic function abnormal (three patients). ADRs not expected from the “Precautions” section of the package insert included hyponatremia (one patient) and anal erosion (one patient). With the exception of one case of diarrhea in which the outcome was unclear, all cases recovered or improved.
The occurrence of ADRs did not differ greatly between this study and the previous clinical studies including a pre-approval clinical study of ZOSYN® in children with febrile neutropenia; a special drug use-results survey in children after the approval of sepsis, pneumonia, pyelonephritis, and complicated cystitis as indications; and a special drug use-results survey in children after the approval of peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis as indications.
The efficacy assessment showed a response rate of 88.0% in 117 patients, which was consistent with those of previous clinical studies and special drug use-results surveys.
This study revealed no clinically significant problems related to the safety and efficacy of ZOSYN® in children with febrile neutropenia, indicating that the drug remains a useful empiric treatment for infectious diseases, as is currently recommended by various guidelines.
