oral sodium phosphates (osp) linked to kidney failure
fda issues highest warning for prescription osp products and additional warnings for over-the-counter osps
On December 11, 2008, the U.S. Food and Drug Administration (FDA) issued a Safety Alert calling for a black box warning to consumers and health care providers that a serious form of kidney injury, acute phosphate nephropathy, had been associated with the use of prescription OSP, namely Salix Pharmaceuticals’ Visicol and Osmo Prep. These products are generally prescribed prior to a colonoscopy or other medical procedure.
The FDA expressed equal concern of the use of over-the-counter (OTC) products such as Fleet Phospho-soda and Fleet Accu-Prep solutions for bowel clearing, though it emphasized that using the OTC products in low doses as a laxative did not pose a risk of acute kidney failure. However, the FDA plans to amend the labeling conditions for OTC OSP products to address this concern with bowel cleansing use.
In some cases, when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.
In response to the FDA’s stern safety warning, C.B. Fleet Company Inc. announced a voluntary recall of its over-the-counter Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System. On February 13, 2009, C.B. Fleet ceased the sale of its Fleet Prep Kit 1 product.
In a news release, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said, “Though rare, these are serious adverse events associated with the use of oral sodium phosphates — both prescription and over-the-counter products.
“In some cases, these serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk for developing kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products or they did not drink sufficient fluids after ingesting OSP products.”
As a result of the recent consolidation and settlement of Fleet Phospho-soda cases under MDL 2o66, Beasley Allen is no longer reviewing these cases.