{
  "abstract": "The US Food and Drug Administration’s Adverse Event Reporting System (FAERS) is an indispensable pharmacovigilance resource, yet it is increasingly used in ways that go beyond its design, particularly in the academic literature and hospital formulary debates. Researchers and clinicians may treat FAERS outputs as if they were incidence data or comparative risk estimates, which can lead to overconfident conclusions about the relative safety of drugs or formulations. This editorial focuses on common methodological and interpretive errors made by researchers when using FAERS—especially in comparative safety assessment—and outlines how FAERS can be used appropriately as a hypothesis-generating tool rather than a definitive source for clinical decision-making.1–8",
  "authors": [
    {
      "affiliations": [
        "Independent Researcher, Athens, Greece"
      ],
      "name": "Elvira Meni Maria Gkrinia"
    },
    {
      "affiliations": [
        "Department of Basic and Clinical Pharmacology and Toxicology, University of Rijeka, Faculty of Medicine, Rijeka, Primorje-Gorski Kotar County, Croatia"
      ],
      "name": "Andrej Belančić"
    },
    {
      "affiliations": [
        "Department of Clinical and Experimental Pharmacology, Faculty of Medical Sciences, University of Kragujevac, Serbia, Kragujevac, Serbia"
      ],
      "name": "Slobodan M Janković"
    }
  ],
  "title": "Putting FAERS data into perspective: cautionary considerations for comparative safety assessment",
  "uid": "7332829b-598f-5f8e-b87a-5cd63bd3d728"
}