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Statins Safety Signals: From Precautions to Proportionate Evidence‐Based Labeling

Year: 2026

Type: article

Abstract: The recent Cholesterol Treatment Trialists' Collaboration meta-analysis provides the most comprehensive randomized evidence to date regarding statin-associated adverse drug reactions, substantially narrowing the list of harms confidently attributable to statins. Beyond its clinical implications, the analysis highlights important challenges in pharmacovigilance and regulatory risk communication. Precautionary labeling based on low-certainty evidence may inadvertently amplify nocebo effects, reduce adherence to preventive therapies, and contribute to avoidable cardiovascular burden, particularly among vulnerable populations.

Source: Clinical Pharmacology & Therapeutics

DOI: 10.1002/cpt.70419

Authors: Médéa Locquet, Jonathan Douxfils, Patrizio Lancellotti, Jean‐Michel Dogné

Institutions: University of Namur, Namur Research Institute for Life Sciences, University of Liège, Centre Hospitalier Universitaire de Liège

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W7171554735