OsmoPrep Lawsuits Filed Over Kidney Damage From Colonoscopy Drug

Four users of OsmoPrep, a prescription drug used to clear out the bowels before colonoscopy examinations, have filed acute phosphate nephropathy lawsuits against Salix Pharmaceuticals. The complaints come approximately one year after the FDA added a black box warning about the risk of kidney damage from side effects of the oral sodium phosphate drug.

The OsmoPrep lawsuits were filed on December 23 in Burke County North Carolina by four plaintiffs who allege that the drug maker failed to adequately warn consumers about the risk of kidney damage from side effects of OsmoPrep.

OsmoPrep is an oral sodium phosphate product that was introduced in 2006. Also referred to as “The Tablet Prep”, OsmoPrep is marketed as an easier alternative colonoscopy prep because users do not have to drink a lot of bad-tasting liquid. A large number of tablets are taken the day before the colonoscopy to clean out the bowels before the examination.

On December 11, 2008, the FDA required new warnings for OsmoPrep and Visicol, another prescription oral sodium phosphate product. The “black box” warning, which is the strongest warning that can be placed on a prescription medication, was required after the agency received a number of reports of acute phosphate nephropathy, including at least 20 unique OsmoPrep kidney damage reports. The FDA indicated that the onset of kidney injury from OsmoPrep varied, occurring from within several hours of use to up to 21 days later.

In addition to the black box warning labels for OsmoPrep and Visicol, the FDA also indicated that over-the-counter oral sodium phosphate laxatives should not be used at double doses to clear out the bowels, due to the same concerns about the risk of kidney damage. This resulted in a recall of Fleet Phospho-soda, a laxative that was heavily marketed for the unapproved use as a bowel cleanser.

More than 100 Fleet Phospho-soda lawsuits have been filed against the maker of the laxative, C.B. Fleet Co., alleging that plaintiffs developed the oral sodium phosphate kidney damage after using double doses of the laxative for colonoscopy prep according to instructions provided by the manufacturer. All federal lawsuits over Fleet Phospho-soda kidney damage have been consolidated for pretrial litigation as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Ohio.

The new lawsuits over OsmoPrep contain similar allegations against Salix, with Plaintiffs claiming that the company was aware of the kidney side effects with OsmoPrep, yet failed to adequately warn consumers.