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Tuesday, May 5, 2009
New FDA warning: Oral Sodium Phosphate (OSP) Kidney Failure
In December 2008, the FDA announced that the use of oral sodium phosphate products is associated with acute phosphate nephropathy, an acute kidney failure. The oral sodium phosphate products in question are used for bowel cleansing prior to colonoscopy and other procedures. The FDA now requires that oral sodium phosphate products available by prescription carry a boxed warning. Meanwhile, the maker of an over-the-counter oral sodium phosphate product has announced a recall of that product.
Oral Sodium Phosphate Kidney Failure
The FDA has announced that a boxed warning will be added to oral sodium phosphate products, warning of the risk of acute phosphate nephropathy—an acute kidney injury. The announcement comes after more than 20 reports of the condition were linked to the use of oral sodium phosphates. The products receiving the boxed warning are prescription products Visicol and OsmoPrep, which are used for bowel cleansing prior to colonoscopy and other procedures. The FDA has also recommended that another product, Fleet Phospho-soda, should only be used as a laxative and not as a bowel cleanser.
The FDA reports that of the 20 cases of acute phosphate nephropathy associated with the oral sodium phosphates, five cases were reportedly life-threatening and 10 resulted in hospitalization. Furthermore, four patients required dialysis and one patient died from complications of pneumonia. The onset of acute phosphate nephropathy was between seven hours and 21 days following the use of the oral sodium phosphate.
According to the 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." It is a rare and serious adverse event.
People at highest risk of acute phosphate nephropathy are those over the age of 55, those who are hypervolemic or suffer from decreased intravascular volume, those who have baseline kidney disease, bowel obstruction or active colitis, and those who are taking medications that affect renal function.
In addition to a boxed warning, the makers of Visicol and OsmoPrep have been required to develop and implement a risk evaluation and mitigation strategy to ensure that the benefits of those products outweigh the risks.
Meanwhile, CB Fleet, maker of the Fleet Phospho-soda and the Fleet Phospho-soda EZ-Prep Bowel Cleansing System, has voluntarily recalled those two products. The FDA has recommended that those products not be used for bowel cleansing.
Oral Sodium Phosphate (OSP) Kidney Failure Legal Help
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