New Warnings on Colon Preps

(December 14, 2008) - The Food and Drug Administration (FDA) wants new warnings on the drugs that people take before a colonoscopy. (Read about "Colonoscopy") The Boxed Warning for the prescription oral sodium phosphate (OSP) products Visicol and OsmoPrep will 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.

FDA says it is equally concerned about the risks associated with the use of OSP products that are available over-the-counter (OTC), for example, Fleet Phospho-soda, when used at higher doses for bowel cleansing. FDA says he available data do not show a risk of acute kidney injury when these OTC products are used at the lower doses for laxative use. However, when used for bowel cleansing, these products have the same risks as prescription OSP products. FDA plans to amend the labeling conditions for OTC OSP products to address this concern with bowel cleansing use. In light of the continued receipt of reports of acute phosphate nephropathy, FDA is recommending that consumers not use over-the-counter OSPs for bowel cleansing.