Four users of <"http://www.yourlawyer.com/topics/overview/Fleet_Phospho_soda_Recall">OsmoPrep, a prescription oral sodium phosphate (OSP) product, have filed suit against Salix Pharmaceuticals, Ltd., and Salix Pharmaceuticals, Inc. The OsmoPrep lawsuit, which was filed in Burke County, N.C., alleges that the four plaintiffs suffered acute kidney damage due to the use of this bowel cleansing product.
The complaint alleges that Salix was aware of the risks of serious kidney damage at the time of first marketing OsmoPrep and up until health regulators forced Salix to include a black box warning on its label regarding the risk of acute kidney damage. The plaintiffs in this lawsuit claim to have suffered acute phosphate nephropathy because of their use of OsmoPrep, resulting in the need for dialysis.
OsmoPrep, which was first marketed in 2006, contains two types of sodium phosphates, which work by drawing water in the bowels. In addition to OsmoPrep, Salix makes a second prescription OSP product called Visicol. Both OsmoPrep and Visicol are used to cleanse the intestines prior to a colonoscopy. To achieve this, a large number of pills are taken the day before and the day of the colonoscopy
The risk of kidney damage from OSP products has been suspected for some time. In 2006, the U.S. Food & Drug Administration (FDA) issued a Science Paper and a Healthcare Professional sheet describing the dangers associated with the use of OSP products for bowel cleansing. Between the issuance of those publications, the FDA 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. These reports prompted the FDA to order that a black box warning – its most serious safety notice – be added the prescribing information of Visicol and OsmoPrep in December 2008.
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.