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Using Pharmacovigilance Data for Signal Detection of Drug Interactions for Rosuvastatin
Ronja Levomäki1, Päivi Hirvensalo2, Aleksi Tornio2,3
1Pharmaceutical Sciences Laboratory, Department of Natural and Health Sciences, the Faculty of Science and Engineering, Åbo Akademi University, Turku, Finland.
Basic & Clinical Pharmacology & Toxicology
|July 3, 2026
Summary
Combining rosuvastatin with certain drugs inhibiting breast cancer resistance protein (BCRP) may increase the risk of rhabdomyolysis. Pharmacovigilance data revealed elevated risks with febuxostat and ticagrelor, suggesting caution with other BCRP inhibitors.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Safety
Background:
- Rosuvastatin, a statin, is metabolized by breast cancer resistance protein (BCRP).
- Inhibition of BCRP can elevate rosuvastatin levels, potentially leading to muscle toxicity, including rhabdomyolysis.
- Understanding drug interactions with BCRP inhibitors is crucial for patient safety.
Purpose of the Study:
- To investigate the association between concomitant use of rosuvastatin and BCRP inhibitors and the incidence of rhabdomyolysis.
- To analyze pharmacovigilance data for potential safety signals related to rosuvastatin-BCRP inhibitor interactions.
- To identify specific BCRP inhibitors that significantly increase the risk of rosuvastatin-induced rhabdomyolysis.
Main Methods:
- Utilized the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
- Analyzed rosuvastatin-related adverse event reports from 2013-2023.
- Compared rhabdomyolysis occurrence in patients taking rosuvastatin with and without BCRP inhibitors, calculating Reporting Odds Ratios (RORs).
Main Results:
- Identified 9777 rosuvastatin-related reports, with 815 involving rhabdomyolysis.
- Out of 71 BCRP inhibitors, 19 had sufficient data for analysis.
- Significantly increased RORs for rhabdomyolysis were observed with febuxostat (ROR 2.47) and ticagrelor (ROR 4.15), as well as amiodarone, erlotinib, and rifampicin.
Conclusions:
- Concomitant use of rosuvastatin with specific BCRP inhibitors, notably febuxostat and ticagrelor, is associated with an increased risk of rhabdomyolysis.
- The findings support known interactions and highlight the potential for other BCRP inhibitors to elevate this risk.
- Clinical vigilance and consideration of drug-drug interactions are recommended when prescribing rosuvastatin with BCRP inhibitors.
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