Prucalopride-associated acute tubular necrosis

Abstract

We report the first case of acute renal failure secondary to prucalopride, a novel agent for the treatment of chronic constipation. The 75 years old male patient was initiated on prucalopride after many failed treatments for constipation following a Whipple’s procedure for pancreatic cancer. Within four months of treatment his creatinine rose from 103 to 285 μmol/L (eGFR 61 decrease to 19 mL/min per 1.73 m²). He was initially treated with prednisone for presumed acute interstitial nephritis as white blood casts were seen on urine microscopy. When no improvement was detected, a core biopsy was performed and revealed interstitial fibrosis and tubular atrophy. The presence of oxalate and calcium phosphate crystals were also noted. These findings suggest acute tubular necrosis which may have been secondary to acute interstitial nephritis or hemodynamic insult. The use of prednisone may have suppressed signs of inflammation and therefore the clinical diagnosis was deemed acute interstitial nephritis causing acute tubular necrosis. There are no previous reports of prucalopride associated with acute renal failure from the literature, including previous Phase II and III trials.

Keywords: Prucalopride, Acute kidney tubular necrosis, Renal insufficiency, Constipation, Adverse drug event

Core tip: Prucalopride is a novel agent used in the treatment of chronic constipation. We report the first case of acute renal failure secondary to prucalopride four months after treatment initiation. A core renal biopsy after prednisone therapy revealed interstitial fibrosis and tubular atrophy. These findings suggested acute tubular necrosis secondary to acute interstitial nephritis. There are no previous reports of prucalopride associated with acute renal failure from the literature, including previous Phase II and III trials. This case reports highlights the need for monitoring renal function in all patients treated with prucalopride.