The popular over-the-counter bowel cleansing product Fleet Phospho-soda, has been linked to acute phosphate nephropathy (a type of acute kidney injury).
UPDATE: On December 11, 2008, the U.S. Food & Drug Administration (FDA) in association with the manufacturer of Fleet Phospho-soda, C.B. Fleet Company initiated a nationwide recall of the popular bowel cleansing solution. The recall was initiated after the FDA added the strongest safety warning available to oral phosphate drugs that are used before colonoscopies, following reports of kidney damage in several patients.
According to the FDA, it has received more than 20 reports of a serious form of kidney failure among patients taking the bowel-cleansing drugs. Some of the products affected by this action include the following: Visicol and OsmoPrep – both prescription tablets made by Salix Pharmaceuticals and Fleet Phospho-soda, made by C.B. Fleet Company Inc.
FDA Video: Stronger Warnings for Bowel Cleansing Agents
In April 2009, the U.S. Food & Drug Administration issued a warning on Bowel Cleansing Agents and the development of acute phosphate nephropathy, a rare but serious type of kidney injury. Included below is a video issued from the FDA regarding the warning.
Read the Full Transcript: Stronger Warnings for Bowel Cleansing Agents
What is acute phosphate nephropathy?
Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OSPs. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued.
Individuals who appear to have an increased risk of acute phosphate nephropathy following the use of OSPs include persons: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme ACE inhibitors, angiotensin receptor blockers ARBs, and possibly nonsteroidal anti-inflammatory drugs NSAIDs).