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”
Due to the continued reports of kidney problems, the FDA is requiring two manufacturers of prescription sodium phosphate drugs known as Visicol and OsmoPrep to take several steps. The manufacturers of OsmoPrep and Visicol will be required to: add a new “boxed warning” to the products’ labels to warn of the risk of acute phosphate nephropathy. conduct a new clinical trial to study the problems further, provide a medication guide for patients, and “implement a risk evaluation and mitigation strategy to ensure that the benefits of using these products outweigh their risks.”
FDA publications advised doctors and other healthcare professionals to:
- “Avoid use of OSP in patients with kidney disease, impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities.
- “Avoid exceeding the recommended OSP doses and avoid concomitant use of laxatives containing sodium phosphate.
- “Use OSP with caution in patients taking diuretics, ACE inhibitors, ARBs, and NSAIDs.
- “Encourage patients to take the correct OSP dose and drink sufficient quantities of fluids during bowel cleansing. Two published articles suggest that using an electrolyte rehydration solution may decrease the electrolyte abnormalities and hypovolemia associated with OSP bowel cleansing.
- “Obtain baseline and post-procedure labs (electrolytes, calcium, phosphate, BUN, and creatinine) in patients who may be at increased risk for a serious adverse event, including those with vomiting and/or signs of dehydration.
- “Use hospitalization and intravenous hydration during bowel cleansing to support frail patients who may be unable to drink an appropriate volume of fluid or may be without assistance at home.”
Official FDA “Patient Safety News” Videos (April 2009)
- Windows Media Player format (with audio and closed-captioning text)
- RealMedia format and other links (scroll down to Show #85, April 2009)
- “Patient Safety News” Transcript
More Information:
FDA Questions & Answers about Oral Sodium Phosphate
December 11, 2008 FDA press release regarding OSP injuries
Consumer Updates on OSP products from the Food & Drug Administration
For More Information Kidney Problems with Fleet Laxatives (updated June 18, 2009)
Information for healthcare professionals
Tags: defectiveDrugs, kidneyInjury
