In December 2008, the Food and Drug Administration (FDA) issued a black box warning on OSP products, specifically Salix’s OsmoPrep and its similar drug Visicol, after receiving numerous reports of a serious kidney injury occurring after use of the products. The injury is known as acute phosphate nephropathy. Those most at risk of developing the serious kidney injury are the elderly and those with preexisting kidney problems, however some people with no risk factors have fallen ill from OSPs. An FDA black box warning is the most serious warning the FDA can issue and is placed on products that carry a risk of severe adverse events or death.

Following the FDA warning, over-the-counter OSP solutions such as Fleet Phospho-Soda made by C.B. Fleet, were pulled from store shelves. While the FDA says the products are safe when used in lower doses as a laxative, in higher doses the solutions posed the same risk as the prescription OSP products.

Source: CNN

SOURCE: Fleet Attorney › Lawsuits citing kidney injury from OsmoPrep commence

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

ACS and the task force recommend colon screenings beginning at age 50 with one of three tests – colonoscopy every 10 years, a sigmoidoscopy every five years, and a stool blood test annually. ACS also recommends a CT colonography or “virtual colonscopy” and a barium enema every five years. But the Preventive Services Task Force recommends stopping the regular screenings at age 75 unless advised by a physician. It also recommends against screenings for adults older than 85, as “there is moderate certainty that the benefits of screening do not outweigh the harm.” ACS has no recommendations on an upper age limit for colorectal screenings.

Cancer screenings are recommended based on their potential for saving lives by detecting disease early. However, such tests can be physically and emotionally trying, especially for the elderly, which leaves physicians and patients weighing the risks of the screenings against the benefits.

Not only do colonoscopies carry a higher risk of complications such as colon perforation among the elderly, the bowel preparation can also be uncomfortable and sometimes dangerous for older patients. For example, the Food and Drug Administration (FDA) issued a black box warning on oral sodium phosphates, or OSPs, a type of laxative used to clear the bowel before procedures such as colonoscopies, after numerous patients developed a serious kidney injury following use of OSPs. The solutions are no longer recommended for use among older patients as they were more likely to develop the condition than younger patients.

The recommendations are primarily for people who do not have a family history of colorectal cancer. Every patient’s situation is unique, and both ACS and the task force suggest patients discuss their options with their physicians.

Sources:
American Medical News
Associated Press

SOURCE: Fleet Attorney › Task force advises stopping colonoscopies for elderly

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

The study performed at the VA Medical Center in Phoenix, Ariz., cites inadequate bowel preparation by the patient prior to colonoscopies as resulting in earlier follow-up colonoscopies than when adequate cleansing is performed.

“Endoscopists’ ability to detect colonic legions, especially the flat or depressed ones, is greatly linked to the quality of bowel preparation. For years, we have emphasized the importance of adequate bowel preparation for patients to help ensure the detection of adenomas during colonoscopy, especially on the right side of the colon,” explains Dr. Veronika Karasek. “This new finding suggests that endoscopists are taking into consideration the quality of preparation when recommending a follow-up interval, regardless of the findings of the examination.”

As gastroenterologists consider the importance of bowel preparation, they are also evaluating new formulations of bowel preparation products for their patients. In December 2008, the FDA issued a black box warning on prescription brands of a type of laxative known as oral sodium phosphates, or OSPs. Fleet, maker of a popular over-the-counter brand of OSP, also pulled its products from shelves. OSPs were linked to a serious type of kidney injury known as acute phosphate nephropathy.

During the seminars, researchers at the American College of Gastroenterology presented papers evaluating new bowel preparation formulations and approaches.

In a pilot study led by Dr. Ron Palmon at the Mt. Sinai School of Medicine, researchers evaluated the safety and efficacy of Polyethelne Glycol (PEG) plus ascorbic acid (Moviprep) compared to magnesium citrate for bowel preparation before colonoscopy. The randomized study included 90 patients and found that overall colon preparation was excellent or good for 92 percent of those receiving the PEG and ascorbic acid solution, as well as 86 percent of those receiving the magnesium citrate formulation. Sixty-two percent of the patients given the PEG and ascorbic acid formulation indicated that it was easy to fairly easy to take, compared to 82 percent of those given the magnesium citrate formulation.

The study also showed a significant improvement in the quality of bowel preparation when using split dosing with either preparation. Split-dosing involves doses given both the night before a procedure and a few hours prior – versus traditional dosing, given the day before.

“Both PEG with ascorbic acid and magnesium citrate provided good to excellent colon cleansing in almost all the patients we evaluated,” explained Dr. Palmon. “The fact that patients were, for the most part, able to tolerate these products and found them relatively easy to administer suggests that they may be an alternative to phosphosoda. Regardless of which formulation a clinician chooses to recommend, we must all reinforce how vital proper procedure preparation is to colonoscopy.”

SOURCE: Fleet Attorney › Researchers consider new options in colonoscopy prep products

Two years ago, nephrologists and other health care providers who attended the ASN Renal Week seminars heard talks about an emerging concern in the field. Diagnostic test preparations, such as products used to cleanse the bowel prior to colonoscopies, were identified as causing damage to the kidneys.

During the 2007 conference, Dr. Glen S. Markowitz of Columbia University provided an update on the risks of acute and chronic renal failure related to the use of oral sodium phosphate solution, also known as OSPs. This product is widely used to prepare the bowels before procedures such as colonoscopy or surgery. Dr. Markowitz point out that there was a special concern about a rare but serious type of renal failure called acute phosphate nephropathy associated with the use of OSPs.

A year after the 2007 Renal Week conference, the Food and Drug Administration (FDA), after receiving several reports of kidney injury associated with use of OSPs, issued a black box warning on prescription brands of the product, such as Visicol and Osmo Prep. Fleet, makers of over-the-counter OSP solutions, followed suit by pulling their products from store shelves.

The 2009 ASN Renal Week conference will be held in San Diego, California. The annual scientific meeting includes presentations of original research such as free communications and posters, as well as a wide array of symposia, conferences and courses on a full range of topics from basic science to clinical practice and public policy.

SOURCE: Fleet Attorney › 2009 ASN Renal Week is Oct. 27-Nov. 1

Colorectal cancer has the second highest overall cancer death rate. But it is easily treated if caught early. The best way to screen for colorectal cancer is through regular colonoscopies. U.S. health experts recommend people get regular colonoscopies beginning at age 50, or earlier if they have a family history or are showing signs of colorectal cancer, such as blood in the stool. But only about half of the people who should have the procedure actually have it done. Researchers say it is because the procedure is embarrassing, uncomfortable and may cause injury.

Both the standard and virtual colonoscopy require patients to first thoroughly cleanse their bowel. Doctors usually prescribe a laxative or recommend an over-the-counter product that is taken a day or two before the procedure. One of the most common laxatives used to cleanse the bowel is a product known as oral sodium phosphate, or OSP.

OSP is known by the prescription brand names Visicol and Osmo Prep, and OTC brands made by companies such as C.B. Fleet. Earlier this year, the Food and Drug Administration (FDA) issued a black box warning on the products after studies showed a link between OSPs and a serious kidney injury known as acute phosphate nephropathy. The condition can cause the kidneys to fail and some patients have had to rely on dialysis treatments.

Source: Montreal Gazette

SOURCE: Fleet Attorney › Virtual colonoscopy shows promising results