The Rising Misuse of Pharmacovigilance Reporting Systems: A Threat to Evidence‐Based Medicine
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.
Institutions
- Uppsala Monitoring Centre (SE)
- Université de Bordeaux (FR)
- Inserm (FR)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- London School of Hygiene & Tropical Medicine (GB)
- Bordeaux Population Health (FR)
- Springer Nature (New Zealand) (NZ)
- GlaxoSmithKline (Sri Lanka) (LK)
- Université Grenoble Alpes (FR)
- University of Bologna (IT)
Publication Details
- Journal
- Clinical Pharmacology & Therapeutics
- Published
- 2025-12-21
- DOI
- https://doi.org/10.1002/cpt.70180
- Citations
- 1
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 1.31