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# Mortality Concerns Cloud Shionogi’s Cefiderocol: FDA
- URL: https://www.fdaweb.com/mortality-concerns-cloud-shionogis-cefiderocol-fda/
- Published: 2019-10-15T12:00:00.000Z
- Updated: 2026-09-15T01:56:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145246

FDA drug reviewers appear to be focused on mortality concerns with a Shionogi NDA for cefiderocol injection that heads to an advisory committee vote 10/16 for its proposed indication to treat complicated urinary tract infections (cUTI). According to just-posted [briefing materials](https://www.fda.gov/media/131703/download?ref=fdaweb.com), the agency aims to have a discussion on a “finding of increased mortality in the CREDIBLE-CR study in the overall risk benefit considerations for cefiderocol” and it seeks input on whether labeling will suffice to describe the risk or there is a need for additional studies. Cefiderocol is a siderophore cephalosporin with shown activity against several gram-negative bacteria.

The materials note that while the safety and efficacy of cefiderocol have been demonstrated for the treatment of cUTI, “higher mortality in cefiderocol-treated patients was observed in a trial in critically ill patients with a variety of infections due to carbapenem-resistant organisms... While no specific reason for the imbalance in mortality could be identified, it appears that some of the deaths were related to progression of infection/lack of clinical response and were more common in patients with infections due to organisms such as *A. baumannii*, *S. maltophilia*, and *P. aeruginosa*. Whether this difference in mortality is a chance finding or truly reflects a deficit in the activity of cefiderocol in critically ill patients is unclear.”