| OsmoPrep Claims |
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DECEMBER 11, 2008:
"Today, the U.S. Food and Drug Administration 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 (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures." |
C.B. Fleet said it would recall its Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System used to clear the bowels before a colonoscopy. The decision was made because the Food and Drug Administration said Thursday that this class of drugs should be available only by prescription, Fleet said.
BOULDER, Colo., Aug. 9 2007 /PRNewswire/ -- The following statement was released by Laszlo & Associates, LLC: Reports of renal failure and death following the use of Fleet(R) Phospho- Soda(R) as a bowel cleanser go back to the 1990s -- within a few years of when C.B. Fleet Co., Inc., the makers of the popular over-the-counter oral laxative, first began promoting a double dose bowel cleansing regimen.
"Today, the U.S. Food and Drug Administration 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 (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures."