SAFETY ASSESSMENT OF PHOSPHATE BINDERS IN RENAL FAILURE PATIENTS UNDERGOING HEMODIALYSIS: A PROSPECTIVE OBSERVATIONAL STUDY

Background: Hyperphosphatemia is a common complication among patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. Oral phosphate binders are the cornerstone of therapy for controlling serum phosphate levels; however, their use is associated with adverse drug reactions (ADRs) that may affect treatment tolerability and patient outcomes. Careful safety evaluation is therefore essential to optimize therapy and minimize treatment-related complications. Objective: To evaluate the safety profile of phosphate binders in renal failure patients undergoing maintenance hemodialysis by assessing the incidence and pattern of adverse drug reactions associated with calcium acetate and sevelamer. Methods: A prospective observational study was conducted over a period of six months in the Hemodialysis Department of a tertiary care hospital in Kottayam, Kerala. Fifty adult patients receiving maintenance hemodialysis and prescribed phosphate binders were enrolled. Demographic details, clinical characteristics, phosphate binder therapy, and adverse drug reactions were documented using a structured data collection form. ADRs were evaluated throughout the study period, and descriptive statistical analysis was performed using IBM SPSS version 22.0. Results: Among the 50 study participants, 15 patients received calcium acetate and 35 received sevelamer. Gastrointestinal adverse effects were the most frequently observed reactions. Hypercalcemia was reported only among patients receiving calcium acetate (n = 2). Diarrhea occurred in two patients receiving calcium acetate and two receiving sevelamer. Constipation was observed only with sevelamer (n = 2), whereas colicky abdominal pain (n = 1) and gastritis (n = 1) were reported only with calcium acetate. Overall, calcium acetate demonstrated a higher frequency of adverse drug reactions than sevelamer. Conclusion: Phosphate binders were generally well tolerated in patients undergoing maintenance hemodialysis. Most adverse drug reactions were mild and predominantly gastrointestinal in nature. Calcium acetate was associated with a greater incidence of adverse reactions, particularly hypercalcemia, whereas sevelamer demonstrated a comparatively favorable safety profile. Regular monitoring of adverse drug reactions and individualized selection of phosphate binders are essential to ensure safe and effective long-term management of hyperphosphatemia in hemodialysis patients.