Severe kidney injury has been reported following use of over-the-counter Fleet laxative products, leading to an FDA warning and a manufacturer recall of the oral sodium phosphate (OSP) products.

Laxative products marketed as “Fleet Phospho-soda,” “Fleet ACCU-PREP,” “Fleet EZ Prep,” and “Fleet Phospho-soda E-Z Prep Bowel Cleansing System” have been recalled by the manufacturer after the U.S. Food and Drug Administration (FDA) warned that use of the products has led to more than 20 reports of acute kidney injury caused by OSP products.  The FDA instructed healthcare professionals to stop using of the products for bowel cleansing.

The FDA reports that use of the oral laxative Phospho-soda products made by C.B. Fleet Company can cause serious kidney damage known as “acute phosphate nephropathy,” a form of acute renal failure. The condition is also known as “nephrocalcinosis.”  Acute phosphate nephropathy is a build-up of calcium-phosphate crystals, which can create permanent renal impairment requiring chronic dialysis.

Symptoms of acute kidney injury include: malaise, lethargy, drowsiness, decreased urine volume, and swelling of the ankles, feet, and legs, according to the FDA.

The FDA has issued a warning to healthcare professionals to alert them to this problem with the use of the Fleet “Phospho-soda” and “ACCU-PREP” oral sodium phosphate (OSP) products for bowel cleansing.

According to the FDA, the OSP products associated with the kidney damage problems “are commonly used for bowel cleansing prior to colonoscopy, radiographic procedures, and surgery.”  Fleet marketed these products as over-the-counter medications.  However, the FDA has recently stated that this type of medication should only be issued with a prescription when used for bowel cleansing.  It was this warning about over-the-counter use that led to the recall of the Phosph-soda

Doctors and other healthcare providers have been using the Fleet laxative products associated with these problems in spite of published reports of acute phosphate nephropathy as early as 2003. More than 20 incidents were reported in a published case series in 2005. FDA warnings were first issued in May 2006, and continued, with increasing urgency, through the latest warning of serious adverse events in December 2008, which led to the manufacturer recall.

Fleet began pulling the laxative products from store shelves shortly after the December 2008 FDA warning, but is considering options for putting the products back on the market, according to a statement by Fleet’s chief scientific officer, Chris McDaniel, in a June 29 article in The News & Advance newspaper in Lynchburg, Virginia.

Those most at risk of developing kidney failure problems after using the Fleet laxatives, according to the FDA, include patients who are:

• age 55 and above, or
• have kidney disease, or
• suffer from bowel obstruction, or
• have active colitis, or
• are dehydrated, or
• are taking “diuretics, ACE inhibitors, ARBs, and possibly NSAIDS”

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