FDA Warning on Acute Kidney Injury associated with Bowel Cleansing

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Group Warning on bowel cleansing prior to colonoscopy or other

procedures.

FDA has become aware of reports of acute phosphate nephropathy, a

type of acute kidney injury, associated with the use of oral sodium

phosphate products (OSP) for bowel cleansing prior to colonoscopy or

other procedures. These products include the prescription products,

Visicol and OsmoPrep, and OSPs available over-the-counter without a

prescription as laxatives (e.g., Fleet Phospho-soda). In some cases

when used for bowel cleansing, these serious adverse events have

occurred in patients without identifiable factors that would put them

at risk for developing acute kidney injury.

FDA is requiring the manufacturer of Visicol and OsmoPrep, the two

OSPs available by prescription only, to add a Boxed Warning to the

labeling for these products. FDA is also requiring that the

manufacturer develop and implement a risk evaluation and mitigation

strategy (REMS), which will include a Medication Guide, to ensure

that the benefits of these products outweigh the risk of acute

phosphate nephropathy, and to conduct a postmarketing clinical trial

to further assess the risk of acute kidney injury with use of these

products. FDA recommends, in light of the risk of acute phosphate

nephropathy, over-the-counter laxative OSP products should not be

used for bowel cleansing. Consumers should only use OSPs for bowel

cleansing pursuant to a prescription from a healthcare professional.

Read the MedWatch 2008 safety summary, including a link to the FDA

Drug Information Page, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#OSP