Product Liability:
Oral Sodium Phosphate
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Bowel Cleansing Oral Preparations Linked to Kidney Failure

Products used for bowel cleansing that contain sodium phosphate, such as Fleet Phospho-soda and Fleet ACCU-PREP have been associated with acute phosphate nephropathy, a type of acute kidney failure.

Available over-the-counter, these oral sodium phosphate (OSP) products are commonly used for bowel cleansing prior to colonoscopy, radiographic procedures, and surgery. Reports to the FDA, have indicated the patients have suffered from the following side effects:

  • Acute phosphate nephropathy – acute kidney failure
  • Severe electrolyte abnormalities
  • Cardiac arrhythmias

The renal impairment suffered by patients is often permanent and may require chronic dialysis. Patients at highest risk for developing kidney failure after using OSP products may be those with the following conditions:

  • Decreased intravascular volume – due to congestive heart failure, cirrhosis, or nephritic syndrome
  • Acute or chronic kidney disease
  • Advanced age
  • Taking medications that affect renal perfusion or renal function, such as diuretics, ACE inhibitors, Angiotensin receptor blockers (ARBs), and Nonsteroidal anti-inflammatory drugs (NSAIDS)

In May 2006, the Food and Drug Association issued an alert to doctors regarding kidney failure associated with the use of OSP products. A previous study, had documented 22 cases of acute phosphate nephropathy in patients who had taken the oral bowel cleansing solutions. Of the cases, 21 involved patients who had been given solutions such as Fleet Phospho-soda or Fleet Accu-Prep. One patient had taken Visicol tablets.

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