ATTORNEY ADVERTISING
December 11, 2008- The U.S. FDA announced that it will add a boxed warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy, an acute kidney injury.
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:
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:
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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