Yesterday FDA sent out an alert about reports of acute phosphate nephropathy which is a type of acute kidney injury and its association with the use of oral sodium phosphate products for bowel cleansing prior to colonoscopy or other procedures. Over-the-counter and prescription products are included in this (Visicol and OsmoPrep and other oral sodium phosphate products such as Fleet Phospo-soda).
FDA has not been able to rule out that some of these patients were dehydrated prior to the ingestion of oral sodium phosphates or if they did not drink sufficient fluids after ingesting the oral sodium phosphates.
What is acute phosphate nephropathy?
On FDA’s website, it explains it is a form of acute kidney injury associated with deposits of calcium-phosphate crystals in the renal tubules. This can result in permanent renal function impairment. This injury is rare but a serious adverse event.
Who is at risk?
FDA says individuals who have an increased risk of acute phosphate nephropathy following the use of oral sodium phosphate products are those who are over 55 years old; those who are hypovolemic or have decreased intravascular volume; those who have baseline kidney disease, bowel obstruction, or active colitis; and those who are using medications that affect renal perfusion or function.
As a result of this warning, Los Angeles Times reports that C.B. Fleet Co. (maker of laxative products) said the company is voluntarily withdrawing its oral, over-the-counter bowel cleansing solutions. The company said it was going to recall its Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System used to clear the bowels before a colonoscopy.