The U.S. Food & Drug Administration (FDA) has issued an urgent, nationwide warning of serious, life-threatening kidney injuries including acute phosphate nephropathy linked to prescription and over-the-counter laxatives including Visicol, OsmoPrep and Fleet Phospho-soda.
What’s the problem?
On December 11, 2008 the FDA notified the manufacturers of oral sodium phosphate products (OSP) that they are required to add a “Boxed Warning” to their products labeling that warns consumers of the risk of developing acute phosphate nephropathy, a type of acute kidney injury.
Some of the oral sodium phosphate products included within this warning include popular prescription OSP’s including Visicol and OsmoPrep, as well as some over-the-counter laxatives (e.g., Fleet Phospho-soda). These products are used for bowel cleansing prior to colonoscopy or other procedures.
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).