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FDA RECOMMENDS CONSUMERS NOT USE OVER-THE-COUNTER ORAL SODIUM PHOSPHATES (Fleet Phospho-Soda) FOR BOWEL CLEANSING! |
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"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."
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Los Angeles Times, 12/12/08: C.B. Fleet recalls bowel cleansing solutions after FDA warning |
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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.
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The Washington Post, 12/11/08: FDA Puts Black-Box Warning on Bowel-Cleansing Drugs |
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Two prescription drugs used to cleanse the bowel before a colonoscopy may cause kidney damage, the U.S. Food and Drug Administration said Thursday.
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Reuters, 12/11/08: UPDATE 1-US FDA warns of kidney damage in bowel cleansers |
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Some sodium-based bowel cleansing products used before colonoscopies can cause kidney damage and must carry a stern warning on the packaging, the U.S. Food and Drug Administration said on Thursday.
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Newsobserver Raleigh Durham, 12/12/08: Bowel Cleaners Tied to Kidney Injury |
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The Food and Drug Administration Thursday ordered new warnings on prescription bowel cleansers marketed by Salix Pharmaceuticals, a Morrisville company that specializes in gastrointestinal treatments.
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