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Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting
Open accessAbstract
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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“There is also some suggestion of a possible link between pioglitazone and bladder cancer and therefore individuals with a history of bladder cancer or unexplained hematuria should probably not receive this drug.98,99”
From Prediabetes: a high-risk state for diabetes development (2012) · cites this paper as [98]
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Metadata
- Authors
- Piccinni, C., Motola, D., Marchesini, G., & Poluzzi, E.
- Affiliations
- University of Bologna (IT)
- Corresponding author
- Poluzzi, Elisabetta
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2011-05-20
- Volume
- 34
- Issue
- 6
- Pages
- 1369-1371
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC3114317
- OpenAlex
- W2133104620
- Cited by
- 239
- References
- 12
- Citations by year
- 2025: 4 · 2024: 3 · 2023: 1 · 2022: 5 · 2021: 5 · 2020: 2 · 2019: 12 · 2018: 18 · 2017: 16 · 2016: 14 · 2015: 20 · 2014: 23 · 2013: 37 · 2012: 60
- FWCI
- 56.32
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Care (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Metabolism, Diabetes, and Cancer
- Health Sciences › Medicine › Surgery › Bladder and Urothelial Cancer Treatments
- Keywords
- pioglitazone, bladder cancer, drug adverse events, antidiabetic drugs, FDA Adverse Event Reporting System, reporting odds ratio, insulin, metformin, glimepiride, exenatide, gliclazide, acarbose, drug safety
- MeSH terms
- Pioglitazone, Aged, Aged, 80 and over, Urinary Bladder Neoplasms, Female, Humans, Hypoglycemic Agents, Male, Middle Aged, United States, United States Food and Drug Administration, Adverse Drug Reaction Reporting Systems, Thiazolidinediones
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