Tag Archives: oral sodium phosphate

FDA Requires Black Box Warnings for Bowel Cleansers Visicol and OsmoPrep

On November 11, 2008 the Food and Drug Commission issued an alert about the safe use of bowel cleansing products that contain oral sodium phosphate. The FDA is requiring that the manufacturers of prescription Visicol® and OsmoPrep® put Black Box warnings on the labels for these products.  In addition, the FDA intends to change labeling for over-the-counter oral sodium phosphate bowel preps including Fleet Phospho-Soda. New FDA labeling for over-the-counter sodium phosphate products will say that they should not be used for bowel cleansing and will address their safe use as laxatives. The alert follows more than 20 reports of acute phosphate nephropathy, a kidney injury that can cause permanent