Reported Pericardial Toxicities Associated with Acute Myelogenous Leukemia Treatments: A Pharmacovigilance Analysis of the FDA Adverse Reporting Database

• Published in: Current problems in cardiology 2022-11, Vol.47 (11), p.101345-101345, Article 101345
• Main Authors: Janus, Scott E., Heisler, Andrew C., Al Jammal, Mustafa, Chahine, Nicole, Chami, Tarek, Hajjari, Jamal, Mously, Haytham, Badhwar, Anshul, Arora, Shilpkumar, Al-Juhaishi, Taha, Al-Kindi, Sadeer G., Hoit, Brian D.
• Format: Article
• Language: English
• ISSN: 0146-2806; 1535-6280
• DOI: 10.1016/j.cpcardiol.2022.101345

Acute myelogenous leukemia (AML) is one of the most common leukemias experienced in adults and conveys significant morbidity and mortality. While the traditional anthracycline based treatments of AML involves cytarabine, developments in alternatives (liposomal cytarabine, fludarabine, cladribine, azacitidine, decitabine), and targeted agents (midostaurin, gilteritinib, enasidenib, ivosidenib, gemtuzumab ozogamicin, and venetoclax) exist. Multiple cardiovascular adverse events, notably pericardial toxicity, have been observed in small studies; however, to date little is known about the comparative pericardial toxicity among these newer regimens. Due to the paucity of data, we sought to investigate the reported pericardial events and mortality associated with treatments for AML. Utilizing the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS), we identified all adverse events associated with FDA approved treatments for AML (2002-2022). Pericardial events were defined as pericarditis, pericardial effusion and tamponade. We excluded any individuals with age