Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting

  1. Elisabetta Poluzzi, PHD1
  1. 1Department of Pharmacology, University of Bologna, Bologna, Italy
  2. 2Metabolic Diseases & Clinical Dietetics, Department of Clinical Medicine, University of Bologna, Bologna, Italy
  1. Corresponding author: Elisabetta Poluzzi, e-mail: elisabetta.poluzzi{at}unibo.it.

Abstract

OBJECTIVE To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications.

RESEARCH DESIGN AND 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.

  • Received December 22, 2010.
  • Accepted March 11, 2011.

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

This Article

  1. Diabetes Care
  1. Supplementary Data
  2. All Versions of this Article:
    1. dc10-2412v1
    2. 34/6/1369 most recent