The Food and Drug Administration (FDA) has issued a warning that the use of oral sodium phosphate (OSP) products for bowel cleansing has, in some patients, caused a rare but serious and potentially fatal form of kidney failure (renal insufficiency) referred to as acute phosphate nephropathy. Three over-the-counter OSP products used for bowel cleansing prior to colonoscopies, radiographic procedures, and surgeries are Fleet Phospho-soda solution, Fleet Accu-Prep solution, and Visicol tablets.
Serious side effects of Fleet Phospho-soda solution, Fleet Accu-Prep solution, and Visicol tablets include severe electrolyte abnormalities, cardiac arrhythmias, and renal (kidney) failure. Users of these products who already have renal insufficiency and bowel perforation are at an even greater risk for suffering these serious side effects, and patients who have misused or overdosed on sodium phosphate are also at a greater risk for serious side effects. Patients of advanced age and those taking diuretics, ACE inhibitors, ARBs (angiotensin receptor blockers), and NSAIDS (nonsteroidal anti-inflammatory drugs) are also at-risk groups and are more prone to developing the above-mentioned side effects.
In mid-May, 2007, a woman filed a $10 million personal injury lawsuit against the C.B. Fleet Company, maker of Fleet Phospho-soda Bowel Prep Solution. The lawsuit alleges that the Fleet solution interacted with her medication prescribed for hypertension (high blood pressure) and caused kidney damage and failure. The suit further alleges that Fleet was well aware of the potential life-threatening danger of their OSP products but did nothing to protect users of these products. Currently, there are 21 documented cases of patients diagnosed with acute phosphate nephropathy following use of an OSP solution for bowel cleansing prior to a colonoscopy, radiographic procedure, or surgery.
