A1 Refereed original research article in a scientific journal
Using Pharmacovigilance Data for Signal Detection of Drug Interactions for Rosuvastatin; 
Authors: Levomäki, Ronja; Hirvensalo, Päivi; Tornio, Aleksi; Filppula, Anne M.
Publisher: Wiley
Publication year: 2026
Journal: Basic and Clinical Pharmacology and Toxicology
Article number: e70271
Volume: 139
Issue: 2
ISSN: 1742-7835
eISSN: 1742-7843
DOI: https://doi.org/10.1111/bcpt.70271
Publication's open availability at the time of reporting: Open Access
Publication channel's open availability : Partially Open Access publication channel
Web address : https://doi.org/10.1111/bcpt.70271
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/527059159
Self-archived copy's licence: CC BY NC
Self-archived copy's version: Publisher`s PDF
The 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor rosuvastatin is a substrate of breast cancer resistance protein (BCRP). BCRP inhibition increases rosuvastatin plasma concentrations and may result in concentration-dependent muscle toxicity, at worst rhabdomyolysis. We investigated if concomitant use of rosuvastatin and drugs identified as in vitro BCRP inhibitors shows an increased number of rhabdomyolysis events based on pharmacovigilance data. From reports in the US Food and Drug Administration Adverse Event Reporting System for patients using rosuvastatin, we formed interaction (rosuvastatin with inhibitor) and non-interaction (rosuvastatin without inhibitor) groups for 71 BCRP inhibitors. These groups were further divided into subgroups with or without rhabdomyolysis. For each inhibitor, we calculated reporting odds ratio (ROR) and 95% confidence intervals (CIs). We identified 9777 individual rosuvastatin-related reports during 2013–2023, including 815 rhabdomyolysis reports. Of the 71 inhibitors, 19 had enough reports for analysis. Significantly increased RORs were obtained for the clinical BCRP inhibitors febuxostat (ROR 2.47, 95% CI 1.38–4.43) and ticagrelor (ROR 4.15, 95% CI 3.32–5.20). Amiodarone, erlotinib and rifampicin showed significantly increased RORs. Our findings support known interactions involving febuxostat and ticagrelor and suggest that also other BCRP inhibitors may increase the risk of rosuvastatin-induced rhabdomyolysis.
Downloadable publication This is an electronic reprint of the original article. |
Funding information in the publication:
The authors have nothing to report.