The Newly Available FAERS Public Dashboard: Implications for Health Care Professionals

MedWatch reports, after their receipt, are deposited into various databases for further analysis by the Food and Drug Administration (FDA).The FDA's Adverse Event Reporting System (FDA AERS or FAERS) is one such database which contains reports of adverse events (AEs) associated with drugs, biologics, and certain other medicinal products.1 The FDA received more than 1.8 million new AE reports in 2017, and the number of reports in FAERS exceeds 15.9 million.1 Drawing meaningful and actionable conclusions regarding safety of medicinal products from FAERS data is a challenging, intricate, and ongoing process, and the FDA thus far had refrained from making the FAERS data publicly available (notwithstanding availability of these data via FDA's quarterly data files or by making freedom of information requests).In a landmark move, the FDA recently made the FAERS data publicly available through an online dashboard.1 Anyone with access to Internet via a computer (or smartphone) can browse through the AEs reported for various medicinal products from 1968 till the latest quarter (June 30, 2018).Open availability of this resource has several implications for health care professionals (HCPs), as listed below: