Drugs Used In Preparation For A Colonoscopy Alleged To Cause Kidney Damage
A lawsuit has been filed against pharmaceutical company Salix Pharmaceuticals Inc. (“Salix”) alleging that its OsmoPrep medication, used to cleanse the intestines in preparation for a colonoscopy, causes kidney damage. The lawsuit filed on behalf of four individuals alleges that the plaintiffs sustained a variety of serious kidney injuries, including acute phosphate nephropathy, and that some of the injuries resulted in the need for dialysis.
In December, 2008, the Food and Drug Administration (“FDA”) placed a “black box” warning – the most severe warning possible – on OsmoPrep and on another Salix bowel cleanser, Visicol. The FDA stated that OsmoPrep and Visicol carry the risk of kidney damage and directed Salix to develop a risk evaluation and mitigation strategy (REMS), distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of these products, and to conduct a post-marketing clinical trial to further assess the risk of acute kidney injury. The lawsuit alleges, however, that Salix was aware of the two drugs’ dangers before the FDA ordered the “black box” warning.
If you or someone you know were given OsmoPrep and/or Visicol and have suffered kidney damage, please contact us to discuss your legal options.