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REMS for oral sodium phosphates

Executive Summary

FDA is directing manufacturers of Rx oral sodium phosphate products Visicol and OsmoPrep to develop a Risk Evaluation and Mitigation Strategy, agency says Dec. 11. The firms will distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of the products and conduct a post-marketing clinical trial to further assess risk. The agency also added a boxed warning on the risk to labeling. Patients routinely take OSP products to cleanse the bowel before a colonoscopy and other medical procedures. FDA plans to amend the labeling conditions for over-the-counter versions of the OSP products to address this concern with bowel cleansing use
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