PO-03-238 CARDIAC ARRHYTHMIA IN THE PATIENT ON RITUXIMAB. A PHARMACOVIGILANCE STUDY FROM 2010-2022 FAERS DATABASE

Abstract

Rituximab is a commonly used monoclonal antibody in most hematological diseases. Cardiac arrhythmia is one of the most common causes of morbidity and mortality in a hematological patient, given the increased cell turnover and electrolyte imbalance, especially after the treatment. Therefore, we explore potential arrhythmic complications related to the most commonly used drug. Given the high risk of cardiac complications in the age group between 65 and 85, we sought to study Rituximab’s arrhythmic complications and outcomes in this patient population. We conducted a retrospective analysis of all reported cases of arrhythmic complication in patients using Rituximab, utilizing data reported to the FDA and registered in the FDA Adverse Event Reporting System (FAERS) database over the past 12 years. We included patients between the 65 to 85 age group; these cases were identified and classified using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. A total of 28,595 patients aged 65 to 85 were reported to use Rituximab from 2010 to 2022. Among 2797 patients with cardiac complications, 31% (n=883) developed cardiac arrhythmias. 70% (n=619) of the reported cases were hospitalized, and 24% (n=149) died. Most deaths were in males, 60% (n=88) Fig.2. Commonly reported arrhythmia is shown in Fig1. The most frequently reported arrhythmia was atrial fibrillation at 72% (n=635), with a mortality rate of 16%. Furthermore, even incidence of ventricular arrhythmia was low at 6% (n=50), the mortality rate was high at 36%. Despite the relatively lower number (3%) of the total reported cases, the development of arrhythmia in patients using Rituximab was associated with increased hospitalization and mortality. Physicians should be aware of cardiological and rhythmic disorders for a commonly used medication like Rituximab. This might help with the early reorganization of the arrhythmia and finally improve the overall outcomes.