The FDA ( Food and Drug Administration ) has announced 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.
Patients routinely take OSP products to cleanse the bowel before a colonoscopy 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. 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.

In 2006, the FDA issued a Science Paper and a Healthcare Professional sheet describing the risks associated with the use of OSP products for bowel cleansing. Since then, as part of the Agency’s postmarketing surveillance, the FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep. Of the reported cases, three 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.

OSP products should not be used by children under 18 years of age or in combination with other laxative products containing Sodium Phosphate. FDA is recommending that OSP prescription products be used with caution for bowel cleansing by the following at risk groups: people over 55 years of age; people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and people taking certain medicines that affect kidney function, such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs.

Source : FDA, 2008

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