Clin Pharmacol Ther. 2025 Dec 21. doi: 10.1002/cpt.70180. Online ahead of print.
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.
PMID:41422480 | DOI:10.1002/cpt.70180
