Before December 2008 when the FDA began requiring a black box warning on OsmoPrep, many lawsuits were filed concerning the risk of kidney damage from the product's use. Recently, a number of lawsuits have been filed claiming that kidney damage occurred before the black box warning was issued. Included in many of these lawsuits, are the gastroenterologist and the endoscopy center.
The black box warning indicates that older patients are at a greater risk of hypovolemia, bowel obstruction, active colitis, and kidney disease. It also states that patients taking diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and in some cases, NSAIDs are at an increased risk level.
Since 2005, OsmoPrep has been associated with acute kidney injury. Between 2006 and December 2008, the FDA received 20 reports of kidney damage allegedly caused by OsmoPrep.
Is There a Rising Tide of Bowel Prep Lawsuits?