C.B. Fleet Company announced a Fleet Phospho-soda recall in December 2008, for their over-the-counter oral sodium phosphate laxative, which was being widely marketed for use at higher doses as bowel prep before a colonoscopy or other procedures.
Please note that the lawyers at Saiontz & Kirk, P.A. are no longer taking on new cases involving Fleet Phospho-Soda. The content on this page is provided for informational purposes only.
The use of oral sodium phosphate solutions like Fleet Phospho-soda have been linked with an increased risk of kidney injury, known as Acute Phosphate Nephropathy, which could lead to renal failure, the need for dialysis treatment, a kidney transplant or even death.
Although Fleet has known about the risk of their over-the-counter product for years, they did not issue a recall for Fleet Phospho-soda until after thhe FDA issued a warning on December 11, 2008
The product liability attorneys at Saiontz & Kirk, P.A. reviewed potential Fleet Phospho-soda recall lawsuits throughout the United States on behalf of individuals diagnosed with a kidney injury or renal failure after using the oral sodium phosphate solution to clean out their bowels before a colonoscopy.
KIDNEY PROBLEMS WITH FLEET PHOSPHO-SODA
The FDA has identified 21 cases of severe kidney injury among individuals who used oral sodium phosphate solutions like Fleet Phospho-soda and Fleet Accu-Prep, which can develop between several hours and 21 days after using the product for colonoscopy prep.
In 2006, the FDA issued an alert about the risks of kidney problems with oral sodium phosphate products, recommending that prescription products be used with caution among patients with impaired kidney function. Although it was known that the use of high doses of the non-prescription Fleet Phospho-soda posed the same kidney risk, C.B. Fleet failed to adequately warn of the problems.
In December 2008, the FDA indicated that they are requiring the makers of two prescription oral sodium phosphate drugs, Visicol and OsmoPrep, to add black box warnings about the risk of acute phosphate nephropathy and to develop a risk evaluation and mitigation strategy so that patients are made aware of the risks and benefits of using these products instead of other alternatives for bowel cleansing.
The same day, C.B. Fleet announced a Phospho-soda recall, since the FDA determined that oral sodium phosphate products should only be available for bowel prep by prescription. The recall was issued for:
- Fleet Phospho-Soda Oral Saline Laxative, Unflavorded 1.5 oz
- Fleet Phospho-Soda Oral Saline Laxative, Ginger-Lemon, 1.5 oz
- Fleet Phospho-Soda EZ-Prep Bowel Cleansing System
The company had previously agreed to stop selling Fleet Phospho Accu-Prep in 2006.
FLEET PHOSPH SODA ATTORNEYS
Fleet Phospho Soda products have been used for over 100 years and continue to appear to be safe when used at lower doses as a laxative. However, in the 1990s, C.B. Fleet started marketing the over-the-counter laxative for use at higher doses as part of bowel prep for those undergoing a colonoscopy or colon surgery.
The FDA never determined that double-dosing Fleet Phospho Soda for bowel prep is safe, and it was marketed at doses higher than permitted for over-the-counter oral laxatives containing sodium phosphate.
The Fleet Phospho-soda attorneys at Saiontz & Kirk, P.A. reviewed potential cases for individuals who have been diagnosed with:
- Acute Phosphate Nephropathy
- Kidney Failure or Kidney Disease
New cases are no longer being accepted by Saiontz & Kirk, P.A. This page is maintained for informational purposes only.