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.

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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
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article

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

1 citations
Clinical Pharmacology & Therapeutics
Pharmacovigilance and Adverse Drug Reactions
1.31
article

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

article en
1 citations

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.

Clinical Pharmacology & TherapeuticsVol. 119(2)
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)
Openalex Percentile: Top 16%
Pharmacovigilance and Adverse Drug Reactions
1.31
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