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Kidney Damage Caused by OsmoPrep, Lawsuit Claims

Dec 28, 2009 | Parker Waichman LLP

An OsmoPrep lawsuit has been filed in a North Carolina court alleging that the prescription bowel cleansing product caused four people to suffer acute kidney damage.

Oral sodium phosphate (OSP) products like OsmoPrep are used to cleanse the intestines prior to a colonoscopy.    OsmoPrep is manufactured by Salix Pharmaceuticals, as is Visicol, another prescription OSP product.  In addition, over-the-counter OSP products, such as Fleet Phospho-soda, made by C.B. Fleet, have been used for the same purpose. 

In December 2008, the U.S. Food & Drug Administration (FDA) ordered that  a black box warning - its most serious safety notice - be added the prescribing information of  OsmoPrep.  The agency also ordered that the same warning be placed on Visicol, another prescription bowel cleansing product made by Salix.The FDA mandate was prompted by 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. 

At that time, the agency also warned about possible kidney problems associated  with over-the-counter OSP products, such as Fleet Phospho-soda, and recommended that consumers not use over-the-counter OSPs for bowel cleansing.  Following the FDA warning, C.B. Fleet announced it was issuing a voluntary recall of over-the-counter Fleet Phospho-soda products. 

The OsmoPrep lawsuit alleges  that Salix Pharmaceuticals, Ltd., and Salix Pharmaceuticals, Inc. were aware of the risks of serious kidney damage at the time of first marketing OsmoPrep and up until health regulators mandated the black box warning.  The plaintiffs in this lawsuit claim to have suffered acute phosphate nephropathy because of their  use of OsmoPrep, resulting in the need for dialysis. 

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