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. 2011 Jun;34(6):1369-71.
doi: 10.2337/dc10-2412. Epub 2011 Apr 22.

Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting

Carlo Piccinni  1 , Domenico Motola, Giulio Marchesini, Elisabetta Poluzzi
Affiliations

Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting

Carlo Piccinni et al. Diabetes Care. 2011 Jun.

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.

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References

    1. Suzuki S, Arnold LL, Pennington KL, et al. Effects of pioglitazone, a peroxisome proliferator-activated receptor gamma agonist, on the urine and urothelium of the rat. Toxicol Sci 2010;113:349–357 - PubMed
    1. Dormandy JA, Charbonnel B, Eckland DJ, et al. ; PROactive investigators 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 trial. Lancet 2005;366:1279–1289 - PubMed
    1. Dormandy J, Bhattacharya M, van Troostenburg de Bruyn AR; PROactive investigators Safety and tolerability of pioglitazone in high-risk patients with type 2 diabetes: an overview of data from PROactive. Drug Saf 2009;32:187–202 - PubMed
    1. Food and Drug Administration. FDA drug safety communication: ongoing safety review of actos (pioglitazone) and potential increased risk of bladder cancer after two years exposure [Internet], 2010. Silver Spring, MD, u.s. Food and Drug Administration. Available from http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm Accessed 21 October 2010
    1. European Medicines Agency. European Medicines Agency update on ongoing benefit-risk review of Avandia, Avandamet and Avaglim [Internet], 2010. London, U.K., European Medicines Agency. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/... Accessed 25 October 2010