Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. The black box warning fell on prescription OSPs Visicol and Osmo Prep, both made by Salix Pharmaceuticals.

The ageny also issued a stern safety warning on over-the-counter OSP products. As a result of FDA warning C.B. Fleet Company pulled its OSPs, which include Fleet Phospho-soda and Fleet Accu-Prep from the shelves. While in small doses the Fleet products were deemed safe for use as a laxative, using them in larger doses as a bowel cleanser posed the same risk of kidney injury to consumers.

Those most at risk for developing the severe adverse event following use of OSPs include persons who are 55 years of age or older; who are hypovolemic or have decreased intravascular volume; who have a baseline kidney disease, bowel obstruction or active colitis; and who are using medications that affect renal perfusion or function such as diuretics or NSAIDS. Despite the risk factors, the FDA said that 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.

Over the years several lawsuits have been filed against the makers of OSPs by individuals who have suffered serious kidney injury as result of OSPs, including Mary Little, a resident of Newton County, Georgia. Little’s lawsuit states that Fleet was aware of the risks associated with its product and was obligated to discuss these risks with her physicians and her. By failing to do so, Little suffered serious personal injuries and related damages and is asking for compensation for injuries and emotional distressed caused by ingesting the Fleet product. Her case is being handled by attorney Russell Todd Abney with Beasley Allen Law Firm.

SOURCE: Fleet Attorney › December marks year anniversary of FDA OSP black box warning

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

During a colonoscopy, a doctor inserts a long tube with a camera on the end through the rectum and the intestines to look for polyps, signs of early colon cancer. The procedure can virtually remove the risk of colon cancer if detected early, making regular colon screenings a must for individuals age 50 and older and earlier for those with a family history or who are showing signs of colon cancer.

The second bowel cleaning some physicians recommend prior to a colonoscopy follows the day-before rigors of drinking a laxative solution or taking a pill that purges the bowels of its contents. Doctors have found that even after the bowel has been prepped the day before and no more food consumed, sometimes a collection of dead cells, bacterial secretions, mucus, bile and other debris collect in the bowels during the night and can interfere with the physician’s view during the procedure. The second cleansing is usually preformed about five hours before the colonoscopy is scheduled, requiring some patients to wake extra early to “get moving.”

But one word of caution about the bowel cleansing process. Take a close look at the laxative your are prescribed or told to purchase over-the-counter by your doctor. A type of laxative often used to cleanse the bowel before colonoscopies, called oral sodium phosphates, or OSPs, have been linked to serious kidney injury. In some cases, the injury has resulted in kidney failure. The finding has resulted in a black box warning on prescription brands of OSPs, such as Visicol and Osmo Prep, and the removal of over-the-counter Fleet OSPs. If you have experienced kidney injury days, weeks or even months after taking OSP products to cleanse the bowel, you may have a claim against the manufacturer.

Source: Boston.com

SOURCE: Fleet Attorney › Second bowel cleansing recommended for colonoscopies

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