Attorney Russell Todd Abney

In October 2007, Little ingested the product in preparation for a colonoscopy without knowing that the solution had been linked to permanent kidney damage and renal failure. After using Fleet, a type of laxative known as oral sodium phosphate, or OSP, Little began having complications and suffered from acute renal failure. According to the complaint, the condition has caused her to suffer extensive pain, emotional distress and a reduction in her ability to enjoy life.

Though Fleet was aware of the risk of serious kidney injury associated with the use of its OSP products to cleanse the bowel prior to procedures such as colonoscopy, the company did nothing to warn consumers, according to the complaint. In December 2008, the Food and Drug Administration, responding to numerous reports of kidney injury associated with OSPs, issued a black box warning for prescription brands Visicol and Osmo Prep, made by Salix Pharmaceuticals. In turn, Fleet, which sold over-the-counter OSP products that are not as closely regulated by the FDA, pulled its products off store shelves.

The Little lawsuit states that Fleet, which was aware of the risks, was obligated to discuss with Little, her physicians and other consumers and physicians the risk of severe kidney injury. As a direct result of the defendants’ “malicious and/or intentional conduct,” Little suffered severe personal injuries and related damages. Little and her husband, Willie, are asking for compensation for injuries and emotional distress caused by ingesting the Fleet product.

Read the Little complaint.

SOURCE: Fleet Attorney › Woman who suffered serious kidney injury files suit against Fleet

OSP products include the prescription brands Visicol and Osmo Prep, as well as OTC brands including Fleet Phospha-soda. Over-the-counter OSP products are considered safe if used in low doses to treat constipation. But Fleet began marketing the product in higher doses as a bowel cleanser, which prompted the same risk of kidney damage and the form of kidney injury known as acute phosphate nephropathy.

OSPs work by pulling fluid from the body and out the colon, causing a laxative effect. While the body is purging itself of fluids, calcium-phosphate crystals can form in the kidneys, blocking the renal tubes. Symptoms of OSP-related kidney damage can come immediately or take as long as a few days or few weeks to surface. These symptoms include lethargy, drowsiness, decreased urine output, and swelling of the legs, ankles and feet. Often, the diagnosis isn’t immediately linked to use of OSP.

To date, more than 50 lawsuits have been filed against Fleet by people who suffered kidney injury from use of OSPs, including one recently settled in Virginia in which the lone plaintiff was awarded $10 million.

SOURCE: Fleet Attorney › Lawsuits mount against maker of over-the-counter bowel cleanser

Prepping for a colonoscopy is considered by some to be the most uncomfortable part of the procedure. It is important to cleanse the bowel thoroughly so the physician who is conducting the colonoscopy can see the colon clearly. Your doctor will tell you how to prep for your colonoscopy, but in general, there are two main types of preparations – polyethylene glycol and oral sodium phosphates.

Polyethylene glycol – This type of laxative is available by prescription only and is sold under the brand names GoLYTELY, GlycoLax, Fortrans, TriLyte, Colyte, Halflytely, MiraLAX and MoviPrep. The solution is usually taken by mouth but is sometimes given in the hospital through a tube inserted into the nose. The solution acts as a laxative, causing mild diarrhea that flushes all solid material from the colon.

Oral sodium phosphates (OSP) – This saline laxative product, also known as OSP, is available by prescription under the brand names Osmo-Prep and Visicol and was once available over-the-counter under brand names such as Fleet Phospho-soda and Fleet Accu-Prep. The solution is taken by mouth according to doctors’ or the labels’ instructions. OSPs work by drawing liquid from the body into the colon, which can cause severe dehydration.

Earlier this year the Food and Drug Administration (FDA) issued a black box warning on the prescription OSP products, Osmo-Prep and Visicol, warning of the risk of a rare but serious kidney injury known Acute Phosphate Nephropathy. The FDA also raised concerns about over-the-counter OSP products which led C.B. Fleet to recall its over-the-counter products. They are now available by prescription only.

While some patients, such as the elderly and those with kidney problems, may be at higher risk for the kidney injury, even healthy individuals have been diagnosed with Acute Phosphate Nephropathy following use of OSPs.

Before a colonoscopy, be sure to discuss options in bowel cleansers with your doctor and whether using OSP products is right for you.

SOURCE: Fleet Attorney › Weigh bowel cleaning options before colonoscopy