title: Tigecycline-related pancreatitis: a review of spontaneous adverse event reports.
abstract: 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.
  
  
  METHODS
  Retrospective cohort study.
  
  
  METHODS
  Spontaneous reports in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database generated between January 1997 and December 2010.
  
  
  METHODS
  Sixty-two patients who experienced pancreatitis while receiving tigecycline therapy.
  
  
  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.
  
  
  CONCLUSIONS
  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: Beth Israel Medical Center, Newark, New Jersey 07112, USA. ufan96@yahoo.com
authors: Emmanuel
authors: E
authors: Okon
authors: Christian
authors: C
authors: Engell
authors: Robbert
authors: R
authors: van Manen
authors: Jack
authors: J
authors: Brown
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000009:adverse effects / Q000031:analogs & derivatives*; D010195:Pancreatitis / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology*; D012189:Retrospective Studies; D000078304:Tigecycline; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000639:trends
chemical_list: D000900:Anti-Bacterial Agents; D000078304:Tigecycline; D008911:Minocycline