Mesalamine-Associated Cardiac Adverse Events in Elderly (65-85 years) Patients with Ulcerative Colitis: A FAERS 2020-2026
Mesalamine is widely considered as first line treatment for maintaining remission in patient with mild-to -moderate ulcerative colitis. While treating elderly (65-85 years old patient with mesalamine,certainly cardiovascular disorders occur consequence as adverse events and life threatening.
Introduction: Mesalamine is widely considered as first line treatment for maintaining remission in patient with mild-to -moderate ulcerative colitis. While treating elderly (65-85 years old patient with mesalamine,certainly cardiovascular disorders occur consequence as adverse events and life threatening.
Objectives: The objective of this study was to evaluate the mesalamine associated cardiac disorder while treating elderly ulcerative colitis patients.
Methods: FAERS reports collected from January 1,2020 to April 14 ,2026 were retrospectives analysed.Extracted variables included age(65-85 years),sex,year of report,seriousness,clinical outcome,adverse event category and concomitant medication .Descriptive statistics were used to summarize frequencies and percentages. The clopper-Pearson analysis was used due to the small samples size.
Result: A overall case report in cardiac disorder due to mesalamine were reported for 2020 to 2026 is 4,770 adverse events through FAERS. while treating ulcerative colitis elderly patients (65-85 years) were total of 36 case reports were analysis. Most of patient survived (35/36,97.2%) out of 36 cases, hence one fatal case (2.8%) was non-serious. The confidence interval (CL) for mortality 95% CL≈0.07% to 14.5%.Since highest annual reporting frequency occurred in 2023 (18/36,22.2%) and 2021 (5/36,13.9%). Cardiovascular disorders (47%) were most frequently reported in adverse events category, followed by dermatological (14%), respiratory (11%), gastrointestinal(8%),neurological(8%),renal(6%)and hematological disorders(6%).
Frequently co-reported medications included vedolizumab (36%), budesonide (8%), infliximab (6%), and others (31%).
Conclusion: Mesalamine associated adverse event reports in elderly ulcerative colitis patient were predominantly serious but rarely fatal. The highest hike report observed in 2023 dynamically treatment cardiovascular events and concomitant medication exposure were prominent,continous vigilance on elderly patient while receiving mesalamine therapy.
Keywords: Mesalamine,Ulceratives Colitis,FAERS,Elderly,Adverse Event,Arrhythmias.
Supporting Image/Graph/Illustration
Mr Dil Prasad Subba1
Mesalamine is widely considered as first line treatment for maintaining remission in patient with mild-to -moderate ulcerative colitis. While treating elderly (65-85 years old patient with mesalamine,certainly cardiovascular disorders occur consequence as adverse events and life threatening.