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

Since the late 1800s, Fleet Phospho-soda has been used as an over-the-counter medication to treat constipation. However, in the 1990s, doctors began prescribing Fleet Phospho-soda as a bowel cleansing agent to be used prior to colonoscopies and other gastrointestinal procedures. It is believed that this practice began at the direction of C.B. Fleet Company, the makers of numerous over-the-counter laxatives, and that C.B. Fleet Company informed doctors that patients could safely and effectively use the product in this manner.

Use of Fleet Phospho-soda as a bowel cleansing agent required doubling and, in some cases, tripling the amount of product that was needed for constipation in order to completely clean the bowels for the planned procedures. Use of the product in this nature caused some persons to develop phosphate toxicity and resulted in renal or kidney failure and injury.

It is unknown how many people have actually suffered renal failure from these products, but according to Ben Locklar, shareholder with Beasley Allen, the medical community did not learn about a possible connection between OSPs and renal failure until it was too late for many people. Though C.B. Fleet Company had received a number of adverse event reports associated with its products, the company was slow in notifying physicians and users of the dangers associated with the products’ use. In 2003, an article appeared in the New England Journal of Medicine, documenting the case of a woman with acute phosphate nephropathy following OSP bowel cleansing. Other articles making similar connections followed over the ensuing months.

Following additional study and review by physicians, and at the FDA’s urging, C.B. Fleet Company modified its label to encourage adequate hydration to help flush the product from the body and to help reduce the risks to users’ kidneys. In May 2006, the FDA issued an alert that identified OSP bowel cleansing agents as a cause of acute phosphate nephropathy (or nephrocalcinosis) and provided guidelines to health care providers about the higher risk patients and the need for adequate hydration.

Despites the FDA’s efforts, additional reports of renal failure were received, resulting in oral Fleet Phospho-soda being pulled from the market. Subsequently, the FDA required a warning for Visicol and Osmoprep, two other OSPs. These products are now only available by prescription.

Kidney failure may not manifest itself until months after a person has taken an OSP. If a person suffers renal failure after using one of these products, he/she should consider that the OSP played a role in the injury and should discuss this possibility with his/her physician. A medical test can help to make this determination.

As a result of the use of these dangerous products, untold numbers of people have suffered renal or kidney injury. To date, a large number of cases have been filed against Fleet Phospho-soda. It is anticipated that more cases will be filed as physicians and patients are made aware that renal failure could have resulted from the use of an OSP.

SOURCE: Fleet Attorney › Longtime laxative no longer available over the counter

Last December, the Food and Drug Administration (FDA) issued a warning to consumers and health care providers about prescription OSP products Visicol and Osmo Prep made by Salix Pharmaceuticals that had caused the serious kidney injury in patients. The agency expressed similar concern for over-the-counter OSP products made by C.B. Fleet such as Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System.

Those products were deemed safe to use in lower doses; however, the products were routinely used in higher doses to prep the bowel before procedures. In May 2006, the FDA issued an alert identifying OSP bowel cleansing agents as a cause of acute phosphate nephropathy and provided guidelines to health care providers about higher risk patients and the need for adequate hydration.

While some patients may have been told by their doctors that use of OSP products contributed to their kidney injury, “the focal point is that there are people who experienced renal failure but never heard that their bowel cleansing product caused it,” Locklar says. This is especially true for patients who became ill prior to the 2006 warning, but also for patients who used the over-the-counter products for personal bowel clearing or over a long period of time as a laxative.

These patients may have only suffered a minor injury or received medical treatment quickly after becoming ill. These patients may not have been formally diagnosed with acute phosphate nephropathy but may have been told by their doctors that they have elevated levels of creatanine, BUN and other indicators that could lead to kidney problems in the future.

Locklar points out that the condition is limited to only OSP products, and that other bowel prep products, such as GO LIGHTLY and Miralax that do not contain OSP have not been linked to kidney injury. However, he says, “anybody experiencing a reaction to any products, we need to talk to them.”

SOURCE: Fleet Attorney › Some may not realize OSP caused kidney injury