title: Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting.
abstract: OBJECTIVE
  To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications.
  
  
  METHODS
  Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by the reporting odds ratio (ROR).
  
  
  RESULTS
  Ninety-three reports of bladder cancer were retrieved, corresponding to 138 drug-reaction pairs (pioglitazone, 31; insulin, 29; metformin, 25; glimepiride, 13; exenatide, 8; others, 22). ROR was indicative of a definite risk for pioglitazone (4.30 [95% CI 2.82-6.52]), and a much weaker risk for gliclazide and acarbose, with very few cases being treated with these two drugs (6 and 4, respectively).
  
  
  CONCLUSIONS
  In agreement with preclinical and clinical studies, AERS analysis is consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.
authors.affiliation: Department of Pharmacology, University of Bologna, Bologna, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Piccinni
authors.forename: Domenico
authors.initials: D
authors.lastname: Motola
authors.forename: Giulio
authors.initials: G
authors.lastname: Marchesini
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Poluzzi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D000077205:Pioglitazone; D045162:Thiazolidinediones / Q000009:adverse effects*; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D001749:Urinary Bladder Neoplasms / Q000139:chemically induced*
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077205:Pioglitazone