GREENSBORO, N.C., Dec. 23 /PRNewswire/ -- Suits were commenced Dec. 23, 2009 in North Carolina for four users who allege kidney damage due to the use of OsmoPrep, a prescription drug used to cleanse the intestines in preparation for a colonoscopy. (Holshouser et al v. Salix Pharmaceuticals, Ltd. and Salix Pharmaceuticals. Inc.)
The actions are against two Morrisville, N.C., pharmaceutical companies, Salix Pharmaceuticals, Ltd., and Salix Pharmaceuticals, Inc. ( SLXP). The company, which specializes in marketing gastrointestinal drugs, began selling OsmoPrep in 2006. It had over $30 million in sales in 2008.
OsmoPrep contains two types of sodium phosphates, which work by drawing water in the bowels. A large number of pills are taken the day before and the day of the colonoscopy. Salix also sells a product, Visicol, with similar chemicals and has the same purpose.
In December 2008, after receiving a number of reports of kidney injury, the FDA required Salix to place a black box warning on the product, as to serious kidney damage occurring after use of OsmoPrep and also Visicol. A black box warning is the most strict type of warning that the FDA can force a drug supplier to use in its labeling.
Also as a condition for continuing to market OsmoPrep, the FDA required Salix to perform what is known as a REMS evaluation--Risk Evaluation and Mitigation Strategies. These are designed to determine which population is more at risk in using the product, such as older person, those who are dehydrated or have pre-existing kidney damage, and those concurrently on other drugs.
The liquid form of these oral phosphates had been used in Fleet Phospho-Soda, an over-the-counter product manufactured by C. B. Fleet in Virginia. Fleet withdrew this product from the market in December 2008 in response to a similar request from the FDA to enhance its warnings.
The four plaintiffs in this suit
|SOURCE Rheingold, Valet, Rheingold, Shkolnik & McCartney LLP|
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