Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting
Open Access
- 20 May 2011
- journal article
- research article
- Published by American Diabetes Association in Diabetes Care
- Vol. 34 (6), 1369-1371
- https://doi.org/10.2337/dc10-2412
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.Keywords
This publication has 11 references indexed in Scilit:
- Antimicrobials and the Risk of Torsades de PointesDrug Safety, 2010
- Changes in Glitazone Use Among Office-Based Physicians in the U.S., 2003–2009Diabetes Care, 2010
- Effects of Pioglitazone, a Peroxisome Proliferator–Activated Receptor Gamma Agonist, on the Urine and Urothelium of the RatToxicological Sciences, 2009
- Glucocorticoid therapy and risk of bladder cancerBritish Journal of Cancer, 2009
- Safety and Tolerability of Pioglitazone in High-Risk Patients with Type 2 DiabetesDrug Safety, 2009
- ???Extreme Duplication??? in the US FDA Adverse Events Reporting System DatabaseDrug Safety, 2007
- Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trialThe Lancet, 2005
- Perspectives on the Use of Data Mining in PharmacovigilanceDrug Safety, 2005
- A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactionsPharmacoepidemiology and Drug Safety, 2002
- Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: a case/non-case study in the French pharmacovigilance system databaseBritish Journal of Clinical Pharmacology, 1997