Bowel Cleansers To Get Black Box Warning: FDA

Law360, New York (December 11, 2008, 12:00 AM EST) -- The U.S. Food and Drug Administration announced Thursday it would add a black box warning to two prescription bowel-cleansing products, Visicol and OsmoPrep, which have been found to cause severe kidney damage under certain circumstances.

The boxed warning will alert consumers of the two products about the risk of acute phosphate nephropathy. Both products, marketed by Salix Pharmaceuticals Inc., are taken to cleanse the bowels before colonoscopies and other medical procedures.

Also Thursday, the FDA expressed concern with over-the-counter bowel cleansers, saying they should be available...
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