STUDY OBJECTIVE: To provide clinicians with an understanding of the comparative occurrence of tigecycline and pancreatitis, and to provide any clinically relevant characteristics that may be useful in identifying the patients at risk. DESIGN: Retrospective cohort study. DATA SOURCE: Spontaneous reports in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database generated between January 1997 and December 2010. PATIENTS: Sixty-two patients who experienced pancreatitis while receiving tigecycline therapy. MEASUREMENTS AND MAIN RESULTS: Disproportionality analysis with bayesian correction methodology was used to compare tigecycline with all other agents listed in the AERS. Disproportionality analysis uses an adverse event relative reporting ratio (RRR) to compare the occurrence of a specific adverse event with an index drug of interest to the occurrence of the same adverse event with similar agents or with all other FDA-approved prescription drugs. The value was considered meaningful if the 5th percentile of the distribution of the RRR (RRR(05)) was 2 or greater. Our review identified 62 potential cases of tigecyline-related pancreatitis. An RRR(05) score of 10.4, 10.38, and 2.87 was determined for tigecycline-related pancreatitis compared with all other agents, systemic antibiotics, and select tetracyclines listed in the AERS, respectively. In addition, a sex-based RRR(05) score was higher in women versus men (14.432 vs 3.125) when tigecycline was compared with all agents in the AERS. CONCLUSION: Our analysis suggests a quantitative signal between tigecycline use and pancreatitis; however, given the limitations of our study, a cause-and-effect relationship cannot be inferred. Thus, additional rigorous scientific analyses are warranted to explore these findings.
STUDY OBJECTIVE: To provide clinicians with an understanding of the comparative occurrence of tigecycline and pancreatitis, and to provide any clinically relevant characteristics that may be useful in identifying the patients at risk. DESIGN: Retrospective cohort study. DATA SOURCE: Spontaneous reports in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database generated between January 1997 and December 2010. PATIENTS: Sixty-two patients who experienced pancreatitis while receiving tigecycline therapy. MEASUREMENTS AND MAIN RESULTS: Disproportionality analysis with bayesian correction methodology was used to compare tigecycline with all other agents listed in the AERS. Disproportionality analysis uses an adverse event relative reporting ratio (RRR) to compare the occurrence of a specific adverse event with an index drug of interest to the occurrence of the same adverse event with similar agents or with all other FDA-approved prescription drugs. The value was considered meaningful if the 5th percentile of the distribution of the RRR (RRR(05)) was 2 or greater. Our review identified 62 potential cases of tigecyline-related pancreatitis. An RRR(05) score of 10.4, 10.38, and 2.87 was determined for tigecycline-related pancreatitis compared with all other agents, systemic antibiotics, and select tetracyclines listed in the AERS, respectively. In addition, a sex-based RRR(05) score was higher in women versus men (14.432 vs 3.125) when tigecycline was compared with all agents in the AERS. CONCLUSION: Our analysis suggests a quantitative signal between tigecycline use and pancreatitis; however, given the limitations of our study, a cause-and-effect relationship cannot be inferred. Thus, additional rigorous scientific analyses are warranted to explore these findings.
Authors: R Andrew Seaton; Armando Gonzalez-Ruiz; Kerry O Cleveland; Kimberly A Couch; Rashidkhan Pathan; Kamal Hamed Journal: Ann Clin Microbiol Antimicrob Date: 2016-03-15 Impact factor: 3.944