Bowel-Clearing Drugs Injure Kidneys

FDA Puts Black Boxed Warning on Drugs

The US Food and Drug Administration (FDA) announced today that it will add a Boxed Warning to the prescription oral sodium phosphate (OSP) 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.

The FDA 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. The 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.

The 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.

Since 2006, the FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep. Of the reported cases, 3 were biopsy-proven cases of acute phosphate nephropathy. The onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use.

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Published on Dec-12-08