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The Rising Misuse of Pharmacovigilance Reporting Systems: A Threat to Evidence‐Based Medicine

Year: 2025

Type: article

Abstract: In recent years, different national and international regulatory authorities, notably the FDA, have made their adverse event repositories publicly available, offering user-friendly dashboards. This has led to a large increase in low-quality, poorly reported research using adverse event reporting databases (e.g., FDA's Adverse Event Reporting System [FAERS]). Such publications producing thousands of statistical associations erroneously presented as "safety signals" can create unscientifically grounded alarm with considerable impact on healthcare provider practices and patient behaviors.

Source: Clinical Pharmacology & Therapeutics

DOI: 10.1002/cpt.70180