Fleet Phospho-Soda Recalled

Prior to a colonoscopy, patients must undergo a bowel cleansing using medications containing sodium phosphate. In December 2008, the U.S. Food and Drug Administration announced it will require a boxed warning on the prescription oral sodium phosphate (OSP) products Visicol and OsmoPrep, used for colonoscopy preparation, to warn consumers about the risk of acute phosphate nephropathy, or acute kidney injury, caused by the products.

The FDA has issued warnings about the use of over-the-counter (OTC) OSP products, including Fleet Phospho-soda, when used at higher doses for bowel cleansing. The FDA received reports of 20 unique cases of kidney injury associated with the use of the OSP products.  In response to the FDA's safety alert, C.B. Fleet Company issued a recall in 2008 of its OTC products Fleet Phospho-soda and Fleet Phospho-soda EZ Bowel Cleansing System. 

Acute phosphate nephropathy, a type of acute renal failure, is a rare, but serious adverse event associated with oral sodium phosphate bowel cleansing. When acute phosphate nephropathy occurs, renal impairment is often permanent and may require chronic dialysis.  Individuals at increased risk typically are of advanced age or have decreased intravascular volume or kidney disease.  In some cases, however, the serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk for developing kidney injury.

Physicians are advised to optimize safety for patients by being familiar with the risk profile of OSP products used for bowel cleansing, and to avoid use of OSP in patients with kidney disease, impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities.

If you have any concerns with colon cleansing products talk to your healthcare provider.  You can also report any serious adverse events associated with the use of these drugs directly to the FDA on MedWatch.

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