Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting
Related Experiment Video
Updated: Jun 2, 2026
Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Carlo Piccinni1, Domenico Motola, Giulio Marchesini
1Department of Pharmacology, University of Bologna, Bologna, Italy.
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.
Related Concept Videos
01:26Oral Hypoglycemic Agents: Biguanides and Glitazones
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:23Dipeptidyl Peptidase 4 Inhibitors
01:19Oral Hypoglycemic Agents: α-Glucosidase Inhibitors
Acarbose and miglitol are typically...