Study Design and Data Collection
This is a retrospective, pharmacovigilance study of adverse event analysis of the U.S. Food and Drug Administration’s Adverse Event Reporting System (FEARS) database. FAERS is an online publicly available post-marketing pharmacovigilance database that records millions of adverse events, medication error reports, and product quality complaints submitted by healthcare professionals, manufacturers, and consumers worldwide for approved drugs and biologic products. Reports are evaluated by clinical reviewers in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The database includes data regarding the suspected pharmaceutical agent, indication for its use, patient characteristics, as well as the reported adverse event including its date of occurrence, nature, and outcome, among others. Since the data is anonymized, approval by an ethics committee (i.e. IRB approval) was not required for this analysis. We aimed to evaluate the cardiovascular adverse events associated with newly FDA-approved multiple-myeloma therapeutic agents from the approval till May 2021. Queries for the specific adverse event terms were performed according to the Medical Dictionary for Regulatory Activities. The terms used include “atrial fibrillation”, “congestive cardiac failure, cardiac failure congestive”, “ventricular dysfunction”, “systolic dysfunction”; “diastolic dysfunction”, “cardiac disfunction”, “cardiac failure”, “cardiomyopathy”, “myocardial infarction”, “angina pectoris”, “coronary artery disease”, “coronary artery occlusion”, “angina unstable”, silent myocardial infarction, “acute coronary syndrome” and were organized in these main groups.