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Kidney Injuries Following Colonoscopies - FDA Acts

Visicol and OsmoPrep, prescription oral sodium phosphate (OSP) medications that many people take as a bowel prep before a colonoscopy, have been linked to acute phosphate nephropathy, a type of acute kidney injury. This problem recently prompted the Food & Drug Administration (FDA) to order that the drugs' makers include black box warnings on their labels about kidney risks. The FDA also said it had seen similar kidney problems in people who used over-the-counter OSP products as bowel preps, and recommended they not be used for this purpose.

In response to the FDA warning, C.B. Fleet Company immediately announced a voluntary recall of its OTC products: Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System.

"Though rare, these are serious adverse events associated with the use of oral sodium phosphates-both prescription and over-the-counter products," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

  • are 55 years or older,
  • are dehydrated,
  • have a history of kidney problems,
  • have delayed bowel emptying,
  • have active colitis, or

take certain medications that affect kidney function, such as diuretic (fluid) pills, angiotensin converting enzyme (ACE) inhibitors (medications that lower blood pressure), angiotensin receptor blockers (ARBs, used to treat high blood pressure, heart or kidney failure), and possibly nonsteroidal anti-inflammatory drugs (NSAIDS, like ibuprofen or other arthritis medications).

What Are The Symptoms?

Acute phosphate nephropathy can result in a decrease in kidney function. Symptoms can include malaise, lethargy, drowsiness, decreased amount of urine, and swelling of the ankles, feet and legs. Early stages may not be associated with any symptoms, and may only be detected by blood tests to measure kidney function (serum creatinine and blood urea nitrogen). It is important to have your doctor follow your kidney function closely, especially if you are at increased risk of developing this side effect. The kidney problems may occur within a few days or weeks after taking the OSP product.

Do I Have A Legal Case - Am I Entitled To Compensation?

You may be entitled to compensation for kidney injuries related to the use of prescription or over the counter OSP products prior to your colonoscopy. Please contact us right away for a free and confidential initial telephone review of your specific circumstances.

To date the available data does not show a risk of acute kidney injury when over the counter OSP products are used at laxative doses, in accordance with the current labeling (up to 3 tablespoons per day). Acute kidney injury has occurred only when the OTC OSP products have been used at higher doses associated with colonoscopy prep.

Related FDA links: