Phospho Soda - Safety Issues

Safety Issues

The use of Phospho soda has been known to lead to Acute Phosphate Nephropathy. According to the U.S. Food and Drug Administration (FDA), "Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OSPs . The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued."

Fleet’s Phospho-soda products have been linked to kidney damage since the 1990s.

On December 11, 2008, the FDA issued a Safety Alert stating that "FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury ... The agency is equally concerned about the risks associated with the use of OSP products that are available over-the-counter (OTC), for example, Fleet Phospho-soda, when used at higher doses for bowel cleansing."