Introduction: Statins' widespread use in cardiovascular disease management raises concerns about adverse drug reactions (ADRs). Comparative ADR profiles across different statin types remain lacking, necessitating further investigation to refine patient management.
Areas covered: The FDA Adverse Event Reporting System (FAERS) database (2004Q1-2024Q2) was leveraged to extract healthcare professional reports where statins were the 'principal suspected' causative agent. A systematic analysis of ADRs for statins (Atorvastatin, Simvastatin, Rosuvastatin, Pravastatin, Lovastatin, Fluvastatin, Pitavastatin) was performed using Ratio of Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Intersection analysis delineated similarities and differences in ADR profiles across various statin types.
Expert opinion: This study identified common ADRs across all statin types, including elevated Blood Creatine Phosphokinase, Chromaturia, and elevated Hepatic Enzymes. Furthermore, a shared ADR of elevated Blood Urea was observed across all statins except Pitavastatin. Specific ADRs, potentially attributable to their distinct pharmacokinetic properties and chemical structures, including hearing loss associated with Atorvastatin, skeletal-related ADRs with Rosuvastatin, and premature labor with Pravastatin. This pharmacovigilance study utilizing spontaneous reporting data revealed previously underrecognized statins safety signals. Findings suggest distinct reporting patterns among statins, warranting dedicated investigations into their clinical considerations.
Keywords: FDA adverse event reporting system; Statins; adverse reactions; precision monitoring; risk signal detection.