Oral sodium phosphate (OSP) laxative and bowel cleansing products manufacturered by C.B. Fleet have been linked to severe kidney damage. The FDA says that it has received more than 20 reports of acute kidney injury and has warned doctors to stop using the product in certain circumstances. The manufacturer recalled the products, Fleet Phospho-soda, Fleet ACCU-PREP, Fleet EZ Prep, and Fleet Phospho-soda E-Z Prep Bowel Cleansing System, and several lawsuits seeking $10 million in damages per plaintiff have already been filed.

Reports of kidney damage

The FDA has reported that oral laxative Phospho-soda products made by C.B. Fleet Company, which are commonly used for bowel cleansing prior to colonoscopy, radiographic procedures and surgery, can cause serious kidney damage medically known as acute phosphate nephropathy or nephrocalcinosis. It is a form of acute renal failure caused by the build-up of calcium-phosphate crystals, which can create permanent renal impairment requiring chronic dialysis. Over 20 reports of such damage have already been reported. Symptoms of acute kidney injury include malaise; lethargy; drowsiness; decreased urine volume and swelling of the ankles, feet, and legs.

FDA warning

Based on the information it has received, the FDA issued a letter to doctors in December 2008 warning them to:

• Avoid use of OSP in patients with kidney disease, impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities.
• Avoid exceeding the recommended OSP doses and avoid concomitant use of laxatives containing sodium phosphate.
• Encourage patients to take the correct OSP dose and drink sufficient quantities of fluids during bowel cleansing.
• Obtain baseline and post-procedure labs (electrolytes, calcium, phosphate, BUN, and creatinine) in patients who may be at increased risk for a serious adverse event, including those with vomiting and/or signs of dehydration.
• Use hospitalization and intravenous hydration during bowel cleansing to support frail patients who may be unable to drink an appropriate volume of fluid or may be without assistance at home.
• Use OSP with caution in patients taking diuretics, ACE inhibitors, ARBs, and NSAIDs.

To view a video on this topic from the FDA, please click here.

Product recall

Fleet recalled the the following products in December 2008:

• Fleet Phospho-soda
• Fleet ACCU-PREP
• Fleet EZ Prep
• Fleet Phospho-soda E-Z Prep Bowel Cleansing System

Although the company has said it is in negotiations with the FDA to convert the products from over-the-counter (OTC) to prescription only, no agreement has been reached.

Lawsuits filed

Several product liability lawsuits have been filed against against the company alleging that it knew about the dangers associated with the drugs from as far back as 1990, but did not adequately warn consumers. It is estimated that nearly 40 lawsuits have been filed in federal courts and those have been consolidated in the Northern District of Ohio. Although each case is unique, one plaintiffs' attorney told Virginia's News & Advance that he expects each plaintiff who experienced kidney damage due to OSPs to seek approximately $10 million in damages.

If you've been injured due to OSPs, contact an Oral Sodium Phosphates attorney to discuss your situation. You may be entitled to compensation for your injuries.