The transfer order, filed June 23, 2009, consolidated 38 actions under Section 1407 in the Northern District of Ohio. The MDL was  assigned to the Honorable Ann Aldrich for coordinated or consolidated pretrial proceedings. According to the order, the Panel on Multidistrict Litigation determined all actions included in the suit share factual questions relating to oral sodium phosphate solution-based (OSPS) products manufactured and sold by Fleet. Since the MDL was formed, the number of cases transferred to the MDL has grown to more than 100.

Plaintiffs in these cases challenge the safety of the Fleet OSPS products and allege personal injuries stemming from their use of those products. In particular, plaintiffs allege high doses of OSPS products could lead to acute phosphate nephropathy, a type of kidney injury, and that Fleet knew of the risks associated with high doses of OSPS but downplayed or obscured those risks.

An April 20, 2010, Fleet and the Plaintiffs Executive Committee (PEC) for the MDL reached agreement in principle upon essential settlement terms. On June 14, 2010, the Insurers, Fleet and the PEC came to a common agreement on all principal terms, and outlined a full settlement agreement on these cases.

Read the MDL 2066 transfer order.

SOURCE: Fleet Attorney › Fleet Phospho-soda kidney damage lawsuits consolidated, settled in MDL

There is no debate that colonoscopies are vital for the early detection and treatment of cancers of the colon and rectum. Colorectal cancer is the third most deadly cancer among American men and women. The American Cancer Society recommends people begin regular colon screenings at age 50 or earlier if they have a family history of the disease or are presenting bothersome symptoms.

But the procedure is no cakewalk. It involves a one- to two-day prep of cleansing the bowel with a laxative solution that can make patients sick, if not uncomfortable. For the procedure, patients are sedated and a surgeon runs a thin, flexible scope into the colon to look for signs of cancer or polyps, which can be immediately removed.

Because of the uncomfortable nature of the exam, doctors worry that too few people actually have colonoscopies. And those who require follow-up exams may be less inclined to go.

Researchers analyzed data from 3,627 participants in a National Cancer Institute-sponsored trial and found “significant underuse” of surveillance colonoscopy among those considered high-risk for colorectal cancer. Within five years of an initial colonoscopy, only 58.3 percent of patients with advanced precancerous growths had a follow-up colonoscopy, which is typically recommended every three year for such patients.

But even more surprising, researchers also found what they called “substantial overuse” of surveillance colonoscopies among people considered low-risk for colorectal cancer.

“This is a clear example of an intervention not being utilized in relation to the risk,” said Dr. Robert Schoen, senior investigator of the study. The report appears in the latest issue of the journal Gastroenterology.

Source: Reuters

SOURCE: Fleet Attorney › Too many colonoscopies performed on those at low risk for colon cancer

That is one reason why colon cancer has become the second leading cause of cancer-related deaths among U.S. men and women combined. Colon cancer is highly treatable if caught early. But symptoms of colon cancer are often unnoticed or nonexistent until the disease progresses into later stages.

Regular colon screenings with a colonoscopy are recommended for people beginning at age 50 and earlier for people with a family history or who have symptoms such as blood in the stool. But colonoscopies are intimidating.

The process involves sending a probe into the colon while the patient is sedated. To prepare for the procedure, patients must spend at day or two cleansing their bowels, which can be uncomfortable and confining. But enduring such procedures to ensure good health is a small price to pay.

If people would have regular checkups and screenings, and heed the advice of their doctors, Graber says, more diseases could be diagnosed in their earlier, more treatable stages. Graber recommends that everyone adopt a more proactive approach to their health care by having an open dialog with their primary care physician about their general health and their personal and family medical history.

SOURCE: Fleet Attorney › People should be more proactive with their health

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

The study focused on the rate of interval colorectal cancer in patients participating in the Polyp Prevention Trial Continued Follow-up Study, a four-year multicenter, randomized, controlled trial designed to examine the effects of a low-fat, high-fiber, high-fruit and vegetable diet on the recurrence of colorectal adenomas, or precancerous polyps. The University of Pittsburg study on the occurrence of interval colorectal cancer appears in the January issue of GIE: Gastrointestinal Endoscopy, the monthly scientific journal of the American Society for Gastrointestinal Endoscopy.

“Despite regular colonoscopy, interval colorectal cancer may occur,” says study lead author Robert E. Schoen. “We set out to examine the rate at which these interval cancers appear.”

The study found that nine cases of colorectal cancer were diagnosed over 7,626 person-years of observation, or a rate of 1.2 per 1,000 person-years of observation. In patients involved in the study who developed colorectal cancer, 78 percent had a history of precancerous polyps. The majority – about 78 percent – were detected at an early stage and thus were considered highly curable.

Colonoscopies are the “gold standard” for detection of colorectal cancer. Screenings are recommended for all individuals beginning at age 50 or earlier for people with a history of colorectal cancer or who are exhibiting symptoms such as blood in the stool. During colonoscopy exams, doctors can detect and remove polyps, some of which can become cancerous if not removed.

SOURCE: Fleet Attorney › Study shows need for thorough polyp removal, continued surveillance

The study, which was conducted by researchers at Sungkyunkwan University School of Medicine in Seoul, Korea, found that when patients drank 2 liters of warm water just prior to a colonoscopy, doctors were able to examine an average of 98.4 percent of large intestine surface. Doctors reported only examining an average of 90.6 percent of large intestine surface in patients who drank 2 liters of cold water prior to the procedure, and 92.2 percent in patients who had no water at all.

Sixty-four participants included mostly male patients, each about 33 years of age, and generally of normal weight. The patients either drank warm water, cold water, or no water along with the standard sodium phosphate solution normally prescribed for colonoscopy preparation. Ten to 11 patients in each group had previous abdominal or gynecological surgery. Twenty-one in the warm water group, 17 in the cold water group, and 17 in the no-water group, had irritable bowel syndrome, a chronic condition that can cause pain, bloating and bowel irregularities.

Under normal circumstances, patients who undergo colonoscopies are generally sedated. However, for the study, patients agreed to forgo sedation during their exams. Those who consumed warm water, in particular those 40 years of age and younger and those with irritable bowel syndrome, reported less pain both during the exam and two hours after the procedure. Patients in the warm water group also required less time for insertion and withdrawal of the examination probe.

While the findings are promising, researchers say that more studies should be done to determine how drinking warm water affects the bowel.

SOURCE: Fleet Attorney › Drinking warm water prior to colonoscopy proves effective

The study looked at data from about 83,000 veterans with AKI. More than half of those patients needed dialysis at least temporarily, and many died prior to leaving the hospital. The Center for Health Quality, Outcomes and Economic Research study focused on veterans with AKI who did not require dialysis and who survived at least three months after leaving the hospital.

According to the data, 30 percent of the AKI patients died over the next two years. The researchers placed patients’ risk of death at about 40 percent higher for people with AKI compared to those without AKI. Patients with a severe form AKI were at an even higher risk for death.

Researchers say that the data was limited in that it did not include information on the serum creatinine test used to diagnose AKI, involved mostly men, did not include information on other causes of death, and did not take into account the long-term risk of chronic kidney disease which can lead to AKI. Researchers say the study’s results may help to inform further studies and improve patient care.

SOURCE: Fleet Attorney › Patients with acute kidney injury at greater risk for premature death

Colorectal cancer is the third most common cancer among men and women in the United States, and is among the most deadly of cancers. In an effort to improve those statistics, doctors began recommending that people have regular colon screenings, such as colonoscopies, to look for signs of the disease. Screenings are recommended beginning at age 50 or earlier for people who have a family history of colorectal cancer or are experiencing symptoms such as blood in the stool.

However, colonoscopies are intimidating. The procedure involves sending a tube with a camera on the end through the rectum and into the large intestines. Patients are sedated during the process, but they must prepare at least a day before the procedure by taking large amounts of laxatives to cleanse the bowel before a colonoscopy.

Between the uncomfortable prep required and the thought of the procedure itself, many people opt to go without. Studies show that less than 20 percent of the people who should be screened for colon cancer actually have a colonoscopy.

Which explains why companies like EDP Biotech are working tirelessly to find a more patient-friendly test. (Not to mention that approval of such a test would mean millions, if not billions, for the company that lands a suitable alternative to colonoscopies.)

EDP Biotech’s ColoMarker test involves adding a chemical to a small blood sample. The reading takes about 30 seconds, and the results are revealed on a computer screen. The test detects a certain marker in the blood that indicates if a patient is clear from colon cancer or needs further testing, perhaps by a colonoscopy.

In tests of 2,400 patients, the ColoMarker detected every case of colon cancer during treatable stages. The company is currently seeking FDA approval and hopes to have the ColoMarker available to the public in one to three years.

Source: WBIR.com

SOURCE: Fleet Attorney › Blood test to detect colon cancer seeks FDA approval

The newly released report includes data from the National Cancer Institute (NCI), part of the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), the American Cancer Society (ACS), and the North American Association of Central Cancer Registries (NAACCR). The data shows a 3 percent decrease in new colon and rectal cancer cases in men and a 2.2 percent decrease in women. Deaths from colon and rectal cancers dropped 3.9 percent in men and 3.4 percent in women.

Using modeling projections of colorectal cancer rates, authors of the report say that with accelerated cancer control efforts in the United States, such as quitting smoking and having regular colonoscopies, as well as more effective chemotherapy treatments for the disease, overall deaths from colorectal cancers could be reduced by 50 percent by 2020.

“This report shows that we have begun to make progress reducing colorectal cancer. Yet, colorectal cancer still kills more people than any other cancer except lung cancer,” said CDC Director Thomas Frieden, M.D. “Reducing smoking further can bring lung and other cancer rates down, and improved colorectal cancer screening can prevent colorectal cancer.”

SOURCE: Fleet Attorney › NCI report: new cases of colon, rectal cancer deaths declining

The new test can detect more than 50 percent of pre-cancers and 85 percent of cancers, compared to 85 and 90 percent of cancers with a colonoscopy, says Kevin Conroy with Exact Sciences Corp. There is no day-long prep required, as with colonoscopy procedures, and the cost of the test is far less expensive – $300 to $400 compared to $2,500 for a colonoscopy.

The new test is expected to undergo clinical trials in 2011 and be submitted for FDA approval in 2012. While Exact Sciences isn’t the only company working to develop more patient-friendly screenings for colorectal cancers, it is the only one that focuses on stool-based DNA testing for cancers of the colon and rectum.

“We’re taking it through an FDA clinical trial and then we intend to commercialize it broadly throughout the U.S., and then eventually globally,” Conroy said.

Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States, with more than 106,000 new cases of colon cancer and 40,000 new cases of rectal cancer reported in 2009, according to the American Cancer Society. Regular colon screenings are recommended for people beginning at age 50 and earlier for people with a family history of colorectal cancer or who are experiencing symptoms such as blood in the stool.

Source: Milwaukee-Wisconsin Journal Sentinel

SOURCE: Fleet Attorney › Less invasive alternative to colonoscopy set for 2011 clinical trial

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

The study looked at two different laxative solutions – polyethylene glycol (PEG) and oral sodium phosphate (OSP). PEG includes products such as Miralax but can be poorly tolerated when taken in large volumes to prepare the bowel for procedures such as colonoscopy. OSP is sold under prescription brands Visicol and Osmo Prep and OTC under brands such as Fleet Phospho-soda. OSPs have been linked to a serious kidney injury known as acute phosphate nephropathy and carry a black box warning issued by the Food and Drug Administration (FDA).

The authors of the clinical trial focused their study on an alternative solution, a 960-mL oral sulfate solution, compared with two liters of PEG in two similarly designed clinical trials. The first trial involved 387 patients who took the entire preparation the day before their colonoscopy. The second study included 364 patients who took half the preparation the day before the procedure and the second half the morning before the exam.

Colonoscopists described the preparations as adequate 94 percent of the time for sulfate and 95 percent of the time for PEG in patients who took the entire preparation the day before the exam. In the second study that split the preparation over two days, colonoscopists rated the preparations adequate 99 percent of the time for both groups.

Adverse events during the study were rare and were unlikely to be related to the preparation. Authors also reported no clinically significant changes in patients’ electrolyte levels or renal functions. Patients receiving sulfate also reported having slightly higher vomiting scores but the difference was likely not clinically meaningful, according to the study’s authors.

SOURCE: Fleet Attorney › Study finds new colon-cleansing prep safer, more effective

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

Proper cleansing of the bowel is necessary for doctors to see the colon clearly. Inadequate cleansing could prevent doctors from detecting polyps or other precancerous growths and may require repeat procedures. Doctors order a specific protocol for their patients, which usually involves a type of laxative that is either taken as a pill or a solution. Both are available over the counter or by prescription.

There are different types of laxatives available. One is a polyethylene glycol electrolyte solution. Brand names of this type of product include GoLYTELY and MoviPrep. This solution increases the amount of water in the intestinal tract to stimulate bowel movements. It also contains minerals that work to replace electrolytes that are passed from the body with the stool.

Another type of laxative – available in both solution and pill form – is oral sodium phosphate, or OSP. There are several brands of OSPs, including the prescription tablets Visicol and Osmo Prep, and over-the-counter solutions such as Fleet Phospho-soda. While effective, concerns have been raised recently over the safety of OSP.

Last year the Food and Drug Administration (FDA) issued a black box warning on prescription OSP products, and Fleet pulled its over-the-counter OSP products from shelves, after numerous reports of a serious kidney injury were linked to use of OSPs. While the elderly are at higher risk, in some cases the serious adverse events occurred in patients with no pre-existing health conditions that would have otherwise put them at higher risk for kidney injury.

SOURCE: Fleet Attorney › Prepping bowel for colonoscopy is ‘necessary evil’

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 involved videotaping without their knowledge seven experienced endoscopists during 8 to 10 colonoscopies. The same endoscopists were then videotaped with their knowledge during 8 to 10 more colonoscopies. Those colonoscopies were graded based on various parameters, such as quality of the examination and length of time taken.

The average inspection time for colonoscopies performed while physicians knew they were being videotaped was longer (7.3 minutes) than when endoscopists were not aware they were being taped (4.9 minutes). Overall quality scores were also higher in the videotaped-aware group, with 3.8 vs. 2.9 on a 5-point scale. Significant improvements were also noticed in examinations of folds, distension and clean up when doctors knew they were being taped.

While videotaping colonoscopy procedures is not standard, given the study outcomes, “perhaps systematic video recording of colonoscopies will be considered” in the future, Dr. Rex says.

SOURCE: Fleet Attorney › Videotaping colonoscopies results in better physician performance

Doctors have been working to improve the technology used during the screening, and according to reports at the annual meeting, their efforts have paid off. One improvement is a disposable device that is passed through the instrument channel of a standard colonoscope, called a Third Eye Retroscope, or TER. The scopes let doctors get a better view of the areas they may otherwise miss with standard screening equipment.

Studies on the use of TER have found the new technique gave doctors 13 percent improved diagnostic yield. In the study of 300 patients, researchers concluded that 15 of 136 precancerous growths and 34 of 257 polyps would have been missed had it not been for the TER.

Another plus is high-definition technology in colonoscopies are giving doctors an even better view of the colon than traditional “white light” colonoscopies. One study included 2,400 patients, half of whom underwent standard exams while the other half had high-definition exams. Thirty percent of precancerous lesions were found in the high-def group compared to 24 in the standard-def group. High-definition is not available at all facilities but should become more widely available as facilities upgrade to newer machines.

SOURCE: Fleet Attorney › Advances in technology improve accuracy of colonoscopies

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

Patients were referred to GIA by the InterFaith Health Clinic and The Free Medical Clinic of America, both Knoxville-based organizations that provide health care to the needy. More than half of the people screened had polyps removed. Of the 48 persons screened Saturday, a total of 25 had polyps removed and sent for testing, 16 women and nine men. Twenty-three had no polyps, 15 women and eight men. Polyps, which are typically benign, may contain a small area of cancer or develop into cancer if not removed.

Colon cancer is the second most deadly cancer. “This is a higher percentage than in the population as a whole,” said Dr. Bergein F. (Gene) Overholt of GIA. “This is a big step in the battle against colon cancer. It was a real privilege to serve this group of people.”

Overholt called on other U.S. gastrointestinal practices to replicate “GIA Screening Colonoscopy Day” to help those less fortunate and to make everyone aware of the need for colon screenings. “The national health care debate has focused attention on the role of physicians and other health care professionals,” he said. “I think this can be a great demonstration of the concern medical professionals have for the well-being of their patients.”

Other screening sponsors include Anesthesia Associates of Knoxville, Mercy Health Partners, Premier Surgical Associates, The Endoscopy Center, GI Pathology of Memphis, Boston Scientific, Interactive Optics, the American Cancer Society and Braintree Laboratories Inc.

SOURCE: Fleet Attorney › GI clinic gives free colonoscopies to the needy

As more cases of the condition were reported to the Food and Drug Administration (FDA), the agency last December issued a black box warning on prescription brands of OSP, such as Visicol and Osmo Prep. C.B. Fleet, makers of over-the-counter OSPs, also pulled their products from store shelves. While the Fleet products were deemed safe when taken in low doses as a laxative, Fleet had recommended doctors to tell their patients to use the over-the-counter OSPs in higher doses to prep the bowel prior to colonoscopies.

Unfortunately, OSPs are still the preferred type of bowel cleanser among many gastroenterologists and patients, The Renal Fellow Network says, which points out that more traditional polyethylene glycol-based colonoscopy prep products such as Go-Lytely are much easier to take but less often used for bowel cleansing.

The black box warning on OSP products cautions patients and health care providers not to have elderly patients use the products as they are at higher risk for developing the condition. But studies show that even younger, healthier individuals have fallen ill after taking the products. Perhaps consumers need to be the ones looking out for their own safety. If your doctor prescribes or recommends you take an OSP product, ask for alternatives. There are plenty of other laxatives on the market. The effort just may save your life.

SOURCE: Fleet Attorney › Take your health into your own hands; Don’t use OSP 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

Kidney injury is a devastating disorder that often occurs as a complication of other serious illnesses and sometimes even treatments. For example, one form of kidney injury known as acute phosphate nephropathy, has been associated with the use of oral sodium phosphates (OSP), a type of laxative often given to patients to cleanse the bowel prior to colonoscopies. Incidents of the injury have skyrocketed in the past decade as more patients have regular colon screenings.

The new test will enable doctors to predict a patient’s outcome in a matter of hours as opposed to one to three days for existing methods of testing for kidney injury.

“The icing on the cake is that the NGAL test is designed to be used on apparatus that already exists in laboratories and hospitals. In this way we have secured that the test will be affordable and readily available to doctors worldwide,” says Thea Olesen, CEO of BioPorto.

The test will be presented this month at ASN Renal Week in San Diego, the yearly meeting point for kidney specialists from all over the world.

SOURCE: Fleet Attorney › New test can identify kidney injury earlier

Dr. Rina Rosin-Arbesfeld of Tel Aviv University’s Sackler School of Medicine has reformulated an antibiotic that has reduced the sizes of polyps in about 80 percent of mice. On average, the mice that were given the drug lived about 30 percent longer than mice that were not treated with the antibiotic. Dr. Rosin-Arbesfeld hopes these findings will lead to a preventative therapy in the suppression of polyp growth, and in stronger doses, in combination with chemotherapy and radiation, to fight existing cancers.

“Our new drug may be able to slow down polyp growth so that it never manifests to full-blown colon cancer,” says Dr. Rosin-Arbesfeld.

Using out-of-circulation and old generation antibiotics, such as that used in Dr. Rosin-Arbesfeld’s research, means that treatment with the antibiotics will not interfere with antibiotics currently used to treat bacterial infections. And it should also speed up the approval process for clinical trials, as it has previously been on the market. TAU’s commercial transfer company, Ramot, has filed for a patent for the new use and discussion is already underway with potential partners about experimental human trials of the drug.

Source: Science Blog

SOURCE: Fleet Attorney › New drug shows promising results in treatment, prevention of colon cancer

“Sometimes it is necessary for people preparing to undergo a medical procedure or examination, such as a colonoscopy or a colon x-ray,” says to Dr. Mark Larson, a gastroenterologist at Mayo Clinic in Rochester, Minn., in the Hartford Courant. “But unless a doctor has recommended it as a preparation for such procedure, I strongly discourage people from colon cleansing. It can cause traumatic injury to the colon and result in long-term medical problems.”

Colon cleansing is the process of releasing the contents from the bowel and intestines. It is a required preparation prior to colonoscopies and other medical procedures so that the physician has a clear view of the bowels. The process usually takes at least a day. Common methods of colon cleansing include enemas or the swallowing of a pill or solution that induces the colon to purge its contents. While the process is prescribed by physicians, some people believe that there are benefits to regularly cleansing the bowel to rid the body of toxins.

However, Dr. Larson explains that the colon and intestines naturally eliminate waste material and bacteria. Excessive colon cleansing may actually harm the bowel’s ability to function properly by weakening the colon muscles, thus making them less efficient. And the argument that the process eliminates nasty toxins? Dr. Larson says there is simply no scientific data to back up that claim.

Another concern is that some products used to cleanse the bowel may actually cause serious kidney problems. Oral sodium phosphates, also known as OSPs, have been linked to a serious form of kidney injury known as acute phosphate nephropathy. Prescription OSP brands Visicol and Osmo Prep made by Salix Pharmaceuticals now carry an FDA black box warning about the serious kidney injury. Over-the-counter OSP brands, such as Fleet Phospho-soda and Fleet Accu-Prep, were promptly pulled off the market for similar concerns.

The safest bet, Dr. Larson says, is to exercise regularly and maintain a healthy diet with plenty of fluids and fiber. If constipation is an issue, talk to your healthcare provider. And if ordered by your doctor to cleanse your bowel for a medical procedure, be sure the laxative you are taking is safe.

SOURCE: Fleet Attorney › Colon cleansing carries risk of traumatic injury, medical problems

Colonoscopies can be lifesavers, identifying colon and rectum polyps even before they become cancerous. Doctors recommend patients begin regular colon screenings at age 50, or earlier if they have a family history of or symptoms suggestive of colorectal cancer, such as blood in the stool.

Somewhere between age 75 and 85, your doctor may discuss ceasing your regular colonoscopy screenings. This is because the risk of complications increases among older patients. Serious complications are rare, but include perforations during the exam and adverse reactions to the laxatives used to cleanse the bowel prior to colonoscopy.

Earlier this year the Food and Drug Administration (FDA) issued a black box warning on some products used to prep the bowel prior to procedures such as colonoscopies. Those products, called oral sodium phosphates, or OSPs, were available both as a pill prescribed by doctors and solutions available over-the-counter, such as those made by Fleet.

While the FDA deemed that the over-the-counter OSP products were safe when used in lower doses as a laxative, when used in higher doses to cleanse the bowel many patients began to suffer from serious kidney injuries. The kidney injuries often occurred within a day or two, but sometimes as much as weeks or months later. One diagnosis specifically for patients who suffered ill effects from OSPs is acute phosphate nephropathy.

While the reaction most often occurs in older patients, younger ones are not immune. As a result of the black box warning on prescription OSPs Visicol and Osmo Prep, Fleet withdrew its over-the-counter OSP solutions from the market.

Since then, numerous lawsuits have been filed against the makers of OSP products for not fully warning about the risk of serious kidney injury. “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,” says Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

SOURCE: Fleet Attorney › Colonoscopy prep important, but beware of OSP solutions

Colonoscopies serve an important purpose – identifying colon polyps even before they are cancerous, in some cases virtually eliminating one’s chances of getting colorectal cancer. Because most cancers of the colon and rectum don’t present symptoms until the later stages, when it is most deadly, doctors recommend patients receive regular colon screenings by colonoscopy beginning at age 50 or earlier if they have a family history or are showing suspicious symptoms.

The procedure is generally safe. One of the biggest concerns expressed by patients is colonoscopic perforation (CP), or bowel perforation caused by equipment used during the colonoscopy exam. While CP is an important part of the benefit-harm calculation of colonoscopy, especially those who do not present symptoms, the risk of CP is rare, occurring in only 1 out of 1,700 procedures.

One study pulled data from more than 10,000 patients undergoing either a colonoscopy or flexible sigmoidoscopy at the Faculty of Medicine Siriraj Hospital in Bangkok, Thailand, between January 2005 and July 2008. It found that over that 3.5-year period only 15 CPs occurred among 10,124 patients who underwent the procedure, or 0.15 percent. Variables such as patient gender, emergency endoscopy, anesthetic method, and the specialty or experience of the endoscopist did not seem to play a role in the outcomes. However, patients over 75 years of age and those who received therapeutic endoscopy were at higher risk of CP.

Older patients also are more likely to suffer from a severe adverse reaction to a type of laxative that is either prescribed to patients or sold over-the-counter to cleanse the bowel prior to a colonoscopy. That type of laxative, known as oral sodium phosphate, or OSP, has been linked to a serious form of kidney injury known as acute phosphate nephropathy. Prescription brands of OSP, such as Visicol and Osmo Prep, now carry a black box warning, and over-the-counter OSP products, such as those made by Fleet, have been pulled from store shelves. While older patients and women are at higher risk from kidney injury from OSPs, younger patients have also experienced kidney problems often weeks or months following use of the OSPs.

SOURCE: Fleet Attorney › Study puts colonoscopy risks into perspective

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

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

Pauly Polyp, developed by Theda Care, uses humor and a bit of attitude to convince people age 50 and older to get a colonoscopy. When you enter the site, aptly titled “I Don’t Want A Colonoscopy,” you enter “Excuse Central.” Just type in an excuse and Pauly Polyp sympathizes, but then offers a helpful tip, “Colorectal cancer is the second leading cause of cancer-related deaths in the United States. Schedule your colonoscopy today and kick colorectal cancer in the end.”

If you need to convince a loved one to get screened, consider sending him a Pauly Polyp e-card:

You spend a lot of time
In the bathroom anyway.
Get a colonoscopy.

Though the cards are humorous, they drive home the message that having colonoscopies are critically important.

Want a more intimate relationship with Pauly Polyp? Friend him on Facebook or follow him on Twitter.  As one Pauly Polyp fan writes, “If you are faced with the colonoscopy, don’t sweat it. The day before sucks. The procedure itself is a breeze.”

The fan is right. Colonoscopies are generally safe procedures, but do keep in mind that some risks have been associated with some products used to cleanse the bowel prior to colonoscopy. These products, known as oral sodium phosphates, or OSPs, are available by prescription under the brand names Visicol or OsmoPrep, and were available over-the-counter in solution from by Fleet. Earlier this year the Food and Drug Administration (FDA) issued a black box warning on OSPs after studies linked the use of the products to a serious kidney injury known as acute phosphate nephropathy.

Just make sure to talk to your doctor about the risks, and your concerns.

SOURCE: Fleet Attorney › Pauly Polyp encourages regular colon screenings

The New England Journal of Medicine says that a colonoscopy colorectal cancer screening is one of the few preventive services shown to reduce future health care costs.

“We know screening for colorectal cancer is good health policy, and makes good economic sense,” commented ACG President Dr. Eamonn Quigley. “When screening procedures detect colon cancer early, nine of ten patients beat the disease.  In the absence of screening, colon cancer is usually found too late and many patients die.  Those are starkly different outcomes that we have the power to change.”

It is the racial minorities, uninsured Americans and Medicare patients who should be tested but are not being screened appropriately, according to the ACG. ACG is committed to national policy changes to improve access to colorectal screening and increased use of these proven prevention strategies, including reversing Medicare’s massive cuts to reimbursement for these tests since the benefit was first introduced, as well as to payments in the ambulatory surgery centers where many screening tests are performed.

“We can point to impressive milestones indicating a trend moving in the right direction, yet much work remains,” Dr. Quigley said. “We will continue to champion the lifesaving potential of colonoscopy and work to expand access to lifesaving screening tests.”

SOURCE: Fleet Attorney › ACG applauds Obama’s support of colorectal screenings

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

Detox was once considered a medical procedure performed in hospitals or clinics designed to rid the body of dangerous and sometimes life-threatening levels of alcohol, drugs or poisons. Businesses picked up on the “healthier living through detox” idea, promoting various cleansings to eliminate toxins in the body that they say cause a host of nasty symptoms such as headaches, bloating, joint pain, fatigue and depression. But some of the body cleansing practices come with serious warnings.

Colon cleansing is perhaps the most talked about method of detox. The practice is used to cleanse the bowel prior to medical procedures such as colonoscopies. Some people follow a similar practice to relieve constipation or to cleanse their colon for health reasons. Solutions or pills – available both by prescription and over the counter – are taken by the consumer to induce a series of bowel movements designed to empty the intestines.

However, Dr. Reyes says there are serious risks associated with colon cleansing. For starters, the practice can cause dehydration, electrolyte imbalance, impaired bowel function, and disruption of the intestinal flora. But an even more serious condition has been linked to some colon cleansing products called oral sodium phosphates, or OSPs. OSP products include prescription brands Visicol and Osmo Prep, and over-the-counter brands such as Fleet Phosopha-soda, and have been linked to a serious kidney injury known as acute phosphate nephropathy.

The bottom line, says Dr. Reyes, is that the human body is well equipped to ward off environmental toxins. “If you’re generally healthy, concentrate on giving your body what it needs to maintain its robust self-cleaning system – a healthful diet, adequate fluid intake, regular exercise, sufficient sleep, and all recommended medical checkups,” he says. “If you experience fatigue, pallor, unexplained weight gain or loss, or changes in bowel function that persist for days or weeks, visit your doctor instead of a detox spa.”

SOURCE: Fleet Attorney › Some detox practices carry serious risks

Beginning at age 50, or earlier for those with symptoms of colorectal cancer or a family history of the disease, we should have regular colonoscopies. However, half of the Americans who should have a colonoscopy don’t have the procedure because it is just too, well, gross. “It’s just the idea that someone is going to be examining the rectal area. They’re just uncomfortable with it,” says patient Adwinna Heads.

The team of researchers put their minds – and hands – to samples of fecal matter to see if a non-invasive technique could identify cancer early. Early on, colorectal cancers have no symptoms at all, which makes it such a deadly disease. What the researchers found is that they could diagnose early stage colorectal cancers in patients based on stool samples alone. This finding suggests that people who have the stool sample test performed may be able to avoid colonoscopies all together.

That is good news considering many people are squeamish about the procedure. Not only does it involve a day of preparation in close proximity to a toilet, it also requires another day for the procedure to be performed. The invasive process has few risks, but some bowel cleansing solutions used in the preparation have been linked to a serious kidney injury known as acute phosphate nephropathy. The type of product is known as oral sodium phosphate (OSP) and is in prescription brand tablets Visicol and Osmo Prep, as well as OTC products such as Fleet Phospho-soda and Fleet Accu-Prep.

SOURCE: Fleet Attorney › Stool sampling may detect gastrointestinal cancers early

The study focused on a trend in the United Kingdom toward reduced sedative use during a colonoscopy in an effort to improve safety. Researchers recruited 109 patients, both male and female, to undergo colonoscopies. One hundred and three procedures were performed. Forty-three of the patients in the study received midazolam, is a very short-acting benzodiazepine that has potent anxiolytic, amnestic, hypnotic, anticulvulsant, skeletal muscle relaxant, and sedative properties.

Every two minutes during the exam patients were asked to grade their level of discomfort from 0 to 10 with 0 being the least uncomfortable and 10 being the most uncomfortable. The mean overall numeric rating scale score was 4.7. Men scored a mean rating of 4.0 and women a 5.2. The median peak score was 7. Discomfort was usually highest at the beginning of the procedure, while in the sigmoid colon.

The study found that discomfort scores were higher in patients with irritable bowel syndrome and diverticular disease. Patients who received midazolam were also more likely to express discomfort than those who received buscopan, an anti-spasmodic that works by relaxing the muscles in the wall of the gut, or nitrous oxide, an anesthetic and analgesic commonly known as laughing gas. Patients who had a preceding gastroscopy also expressed greater discomfort.

Researchers say the results also indicate that midazolam neither relieves discomfort nor makes patients forget the procedure, but some patients, such as those with a previous gastroscopy, females, and those with irritable bowel or diverticular disease may benefit from increased analgesia.

SOURCE: Fleet Attorney › Study of factors that contribute to discomfort during colonoscopy

The research sprang from a national program launched in the UK in 2006 to screen all men and women ages 60-69 with a fecal occult blood test (FOBT), a test to identify blood in the stool. Researchers found that less than 60 percent of eligible people were being tested.

To determine one’s attitude toward colorectal screenings, the researchers asked more than 11,000 people their impressions of FOBT, colonoscopies and whether they were exhibiting any symptoms of colorectal cancer. What they found was that 14 percent of the people reacted negatively about colorectal cancer screenings in general. Thirteen percent said the FOBT was “unacceptable” and 55 percent said colonoscopies were just as bad. Those who were most turned off by the procedures were men, older people and people of South Asian decent.

Those with the best attitudes about colorectal screenings were those who suffered from at least three symptoms usually associated with colorectal cancer and those of Black Caribbean decent.

The survey results pave the way for “culturally relevant screening strategies” to be developed,  Dr. Taskila said.

SOURCE: Fleet Attorney › South Asians more likely to shun colorectal cancer screenings

The company claims the products “flush out up to 30 pounds” and “detoxify your body,” but adds the disclaimer that “these statements have not been reviewed by the Food and Drug Administration (FDA).” The company also does not reveal what type of laxative is in the product. And that is concerning.

Earlier this year the FDA issued a black box warning on prescription oral sodium phosphates, or OSPs, a type of laxative used to cleanse the bowel before procedures such as colonoscopies, following several reports of a serious kidney injury following use of OSPs.

OSPs are also sold over-the-counter and are safe in lower doses as a laxative, but many people use the solutions in higher doses to cleanse the bowel. The black box warning on prescription brands Visicol and Osmo Prep prompted C.B. Fleet to pull its line of over-the-counter OSP products from the market. If the colon cleanse company is falsely making claims from big name celebrities, one can only wonder what type of laxative is in their pills.

SOURCE: Fleet Attorney › Oprah, Oz sue colon cleanse company over false advertising

Sure, the procedure can cause anxiety. Just the thought can make you cringe. And then there’s the process one has to endure to cleanse the bowel even before the procedure begins, a practice that can take a day or more. This involves taking a pill or drinking a solution that forces the intestines to purge their contents.

While an important procedure, it is not without its comics. This week, Sacramento Arts & Entertainment Examiner N.E. Frances, who was preparing for her own colonoscopy, compiled a list of humorous colonoscopy videos. If you’re preparing for a colonoscopy and are feeling a little anxious, check out the colonoscopy humor here.  It’s guaranteed to take at least a little of the stress out of the procedure.

Humor aside, colonoscopies do serve an important purpose. Colorectal cancer is the third leading cause of cancer-related deaths in the United States among men and women combined. Caught early, the disease can be curable, which is why regular colonoscopies are important. Colon screenings are recommended for people beginning at age 50 and younger for those who have a family history or are exhibiting symptoms, such as blood in the stool.

Risks from the procedure are low – about 0.35 percent.

Some patients may also suffer from complications from their bowel-cleansing solution. Recently, the Food and Drug Administration (FDA) issued a black box warning on prescription Oral Sodium Phosphates (OSP) such as Visicol and Osmo Prep because some patients who used the products suffered from a severe kidney injury known as acute phosphate nephropathy. Over-the-counter OSP solutions, such as those made by C.B. Fleet, have been pulled from the market. While the risks with OSPs is higher among older patients, most doctors have turned to other, safer laxatives to prep the bowel before colonoscopy.

Don’t be afraid to talk to your doctor about any concerns you may have about the bowel cleansing process, or the colonoscopy procedure.

SOURCE: Fleet Attorney › Humor takes the anxiety out of colonoscopies

Researchers pored over data from more than 3,600 colonoscopies performed at their center and found that the polyp detection rate was higher in the mornings. Specifically, polyps were found in 29 percent of patients who had procedures in the morning compared to 25 percent of patients who had their colonoscopies in the afternoon. Evidence also indicated that detection rates declined in the afternoons.

Researchers say it is unclear why patients who have the procedure in the morning are more likely to have their polyps detected; however, one theory is that physicians may be less attentive or less vigilant in the afternoons than they are in the mornings. Another factor is that men, older patients, and patients with a history of polyps were more likely to have their procedures in the mornings. Those factors could likely have skewed the data, they say.

What the data does indicate is that the notion should be investigated more, researchers add. If physician fatigue does appear to contribute to fewer polyps being detected, then clinics may make changes in how colonoscopies are scheduled, with fewer in the afternoons or as the day progresses.

Source: Reuters

SOURCE: Fleet Attorney › Could morning colonoscopies be more thorough than afternoon ones?

Health Canada

The move follows a U.S. Food and Drug Administration (FDA) investigation into OSPs, products commonly used to cleanse the bowel before colonoscopies, which found people who use the products were at greater risk of suffering from a serious kidney injury known as acute phosphate nephropathy. The investigation resulted in black box warnings on prescription OSP brands, Visicol and Osmo Prep. And, C.B. Fleet voluntarily recalled its over-the-counter OSP products as well.

Health Canada’s warning is a result of more than 50 “adverse reactions” from people who used OSP products and suffered electrolyte disturbances, kidney injury, gastrointestinal symptoms, cardiovascular and neurological problems, or allergic reactions.

Health Canada says the over-the-counter OSPs are considered safe when used in lower doses to treat constipation, and thus can still be sold in Canada as long as the label does not list using the medication at higher doses for bowel cleansing.

Products in question include Phoslax, Fleet Phospho-Soda Oral Laxative, and Phosphate Solution, also sold under the brand names Option + Phosphates Solution, Pharmasave Phosphates Solution and Reserve Phosphates Solution. Fleet Phospho-Soda Oral Laxative has been voluntarily discontinued in Canada by the manufacturer. Option + Phosphates Solution has been re-labeled and will soon be back on the market. Pharmasave Phosphates Solution and Reserve Phosphates Solution may soon be re-labeled and available to consumers at a later date.

Source: CTV.ca

SOURCE: Fleet Attorney › Canada orders makers of common OTC laxatives to re-label

Colorectal cancers often present no symptoms in the early stages, which is why screenings are important. Signs and symptoms of the disease may include

• A change in bowel habits, including diarrhea or constipation or a change in the consistency of your stool for more than a couple weeks;
• Rectal bleeding or blood in your stool;
• Persistent abdominal discomfort, such as cramps, gas or pain;
• Abdominal pain with a bowel movement;
• A feeling that your bowel doesn’t empty completely;
• Weakness or fatigue;
• Unexplained weight loss.

Some symptoms of colorectal cancer, such as blood in your stool, may indicate other conditions, so it is important to discuss your symptoms with your doctor. He may order a colonoscopy to rule out any serious problems. Discuss with your doctor any concerns you have about the procedure.

While generally safe, the elderly are more susceptible to problems from the procedures, most notably, a type of solution used to clean the bowel prior to colonoscopies, oral sodium phosphate (OSP), has been linked to a serious kidney injury. The prescription products, Visicol and Osmo Prep, now fall under an FDA black box warning and Fleet, makers of over-the-counter OSP products, have pulled them from the shelves.

Sources:
American Cancer Society
Mayo Clinic

SOURCE: Fleet Attorney › Understanding the symptoms of colorectal cancer

Colorectal cancer is the third most common cancer diagnosed in both men and women and the second leading cause of cancer-related deaths among men and women combined in the United States, according to the American Cancer Society. The lifetime risk of developing colorectal cancer is about 1 in 19. Currently, the best defense against colorectal cancer is routine colonoscopies.

While colonoscopies carry few risks, the elderly do experience a higher percentage of complications from the procedure. Preparing for the colonoscopy may also present problems for some patients. Earlier this year the Food and Drug Administration (FDA) placed a black box warning – its strongest warning possible – on prescription oral sodium phosphate (OSP) products used to cleanse the bowel prior to colonoscopy, Visicol and Osmo Prep. The products have been associated with a rare kidney injury known as acute phosphate nephropathy.

The same concern was placed on over-the-counter OSP products such as those made by Fleet. The FDA warning prompted Fleet to remove its OSP products from store shelves.

Source: Technology Review

SOURCE: Fleet Attorney › Vaccine may eliminate need for routine colon screenings

When researchers looked at data from all patients, rates showed a decrease of 2.8 percent in men and 2.2 percent in women. But when data was narrowed to just patients ages 20 to 49, the rates increased 1.5 percent in men and 1.6 percent in women.

Researchers then broke the data down into 10-year age groups (20-29, 30-39, 40-49) and noticed an annual increase of 5.2 percent in men and 5.6 percent in women who were in their 20s. However, among the group under 50, the actual number of cases of colorectal cancer were higher among those ages 40-49.

People are recommended to begin colorectal screenings beginning at age 50, or earlier for people with a family history or with symptoms of colorectal cancer. Colon screenings are usually performed in an outpatient basis following bowel cleansing with the use of prescription or over-the-counter tablets or solutions.

Be advised that some products for bowel cleansing, namely oral sodium phosphate (OSP) such as Visicol and Osmo Prep, now fall under a black box warning as the use of the products increase one’s risk of a serious kidney injury known as acute phosphate nephropathy. OTC OSP products such as those made by C. B. Fleet also have been linked to the condition.

Source: Cortlandt Forum

SOURCE: Fleet Attorney › Colorectal cancer rates rise among young adults

The randomized controlled trial involved 134 people with both chronic kidney disease and metabolic acidosis, a condition in which there is an acid-alkali imbalance in the blood resulting in high blood acidity and low bicarbonate levels in the blood. Kidney failure and metabolic acidosis can be caused by various conditions and even solutions, including oral sodium phosphate (OSP) products, such as over-the-counter Fleet solutions and prescription brands Visicol and Osmo Prep, used to cleanse the bowel prior to colonoscopy, radiological procedure or colon-rectal surgery.

Participants in the study also did not suffer from other medical conditions such as morbid obesity, cognitive impairment, chronic sepsis, congestive heart failure, or uncontrolled blood pressure.

The baking soda, or sodium barcarbonate, treatment was taken by participants daily over a two-year period, and urine samples were taken every two months to check creatinine levels. Creatinine is a waste product that healthy kidneys remove. Measuring how much creatinine is in the urine gives an idea how severe is one’s kidney disease.

Researchers found that only 9 percent of people given the sodium bicarbonate supplements suffered from rapidly progressing chronic kidney disease, compared to 45 percent of those who did not take the supplement. Only 6.5 percent of participants who took the supplement developed end-stage renal failure requiring dialysis, compared to 33 percent of patients who did not take the supplement. The supplements also showed to improve nutritional benefits with no unusual adverse events reported.

The researchers have called for a double-blind, placebo-controlled, multicenter trial to provide stronger evidence of the oral bicarbonate supplement for people with chronic kidney disease.

Source: NHS

SOURCE: Fleet Attorney › Baking soda may help those with kidney problems ward off dialysis

A colonoscopy is a screening for colon and rectal cancers which, if detected early, is highly curable. It is recommended that individuals start screenings at age 50, or sooner for those at higher risk of colorectal cancer or with a family history of the disease.

The study found that a low number of people – about 6.9 per every 1,000 – who had colonoscopies experienced a serious gastrointestinal event, such as perforation or bleeding within 30 days of having a colonoscopy. Among those who experienced a gastrointestinal event, the risk was more than twice as high among adults older than 85 than among those ages 66 to 69. Patients with a history of chronic health problems, such as stroke, chronic obstructive pulmonary disease, atrial fibrillation or congestive heart failure were more likely that those without those conditions to experience a serious gastrointestinal event following a colonoscopy.

The solutions used to prep the bowel prior to colonoscopy may also cause greater risk for the elderly. Earlier this year, oral sodium phosphate (OSP) products Visicol and Osmo Prep received a black box warning from the Food and Drug Administration after receiving numerous reports of a serious kidney injury following use of OSP products. The agency also warned against over-the-counter OSP products, like those made by Fleet.

Use of OSP may cause a form of kidney injury known as acute phosphate nephropathy. Reports show that the elderly may be at greater risk of developing the condition than younger individuals.

The U.S. Preventive Services Task Force advises against colonoscopies among adults over age 85 because the risks of the procedure appear to outweigh the benefits.

Source: Cancer Consultants

SOURCE: Fleet Attorney › Elderly at greater risk of complications following colonoscopy

The black box warning fell on Salix  Pharmaceuticals’ prescription OSP brands Visicol and Osmo Prep, and serious warning was placed on over-the-counter OSP products such as Fleet Phospho-soda and Fleet Accu-Prep. The serious adverse event that was occurring in patients repeatedly over the years was a serious form of kidney injury now known as acute phosphate nephropathy.

Phosphate nephropathy occurs when the kidneys have been severely damaged by the formation of phosphate crystals within the renal tubes. The deposits may result in reduced kidney function. The pieces of calcium may also lead to the formation of stones, or nephrolithiasis. The calcium pieces can damage the nephron and can cause acute renal failure. When the kidney damaged by phosphate nephropathy is biopsied, the pathological findings are typical of nephrocalcinosis.

Imaging tests such as films and CT scans of the abdomen can help identify the disorder. Other tests can help determine the severity. Prognosis varies depending on the extent of complications and the cause of the disorder. Possible complications include acute renal failure, chronic renal failure, kidney stones and obstructive uropathy. Affected individuals may experience suddenly decreased urine output and decreased consciousness.

SOURCE: Fleet Attorney › Severe kidney injury linked to use of OSP products

“In retrospect, multiple risk factors for this condition … were identified,” according to a case review published by the National Center for Biotechnology Information (NCBI). The woman had hypertension; used diuretics and AT-II receptor blocker; was of female gender and advanced age; and experienced volume depleting due to vomiting and nausea. “If these factors had been taken into consideration prior to prescribing this drug, acute and chronic renal failure would have been prevented.”

But, even patients without risk factors have experienced serious kidney injury following use of OSP products, which earlier this year prompted the Food and Drug Administration (FDA) to issue a black box warning on prescription OSP products such as Visicol and Osmo Prep. The agency expressed similar concern for over-the-counter OSP products, such as Fleet Phospho-soda and Fleet Accu-Prep. In turn, manufacturer C.B. Fleet issued a recall of its over-the-counter products.

Despite the warnings, authors of the NCBI article issued this opinion: “On the basis of the current state of knowledge the evidence seems to be quite compelling not to prescribe these drugs in patients with one or more associated risk factors. It could even be argued that these drugs should not be prescribed at all.”

SOURCE: Fleet Attorney › OSP products ‘should not be prescribed at all’

According to the Jamaica Observer, several pharmacies still carry the over-the-counter products. Sources within the Ministry of Health say that the decision not to recall the drug in that country is likely because the over-the-counter OSPs are regulated as a “pharmacy only” drug, meaning they should only be sold under the supervision of a registered pharmacist. Reporters checked several pharmacies and noticed the procedure was not in place and that the solutions were widely available outside the pharmacies’ dispensaries.

Facey Commodity Ltd., Jamaican distributors of Fleet OSP products, says Fleet’s recall of its OSP products was not a worldwide recall. “The reason for that recall was that it was readily available and easily accessible to all and sundry in the States. It was being sold over-the-counter,” a Facey Commodity Ltd. spokesperson told the newspaper. “The difference is that here, according to the registration, it is only sold by pharmacists. It’s not registered in the island to be sold outside the dispensary.”

C.B. Fleet has asked that consumers there not purchase the products for bowel cleansing but to consult with their physicians for alternatives.

SOURCE: Fleet Attorney › Recalled over-the-counter OSP products still on shelves in Jamaica

Even if patients aren’t diagnosed with the type of renal failure associated with OSP use, known as Acute Phosphate Nephropathy, they may still be at risk from conditions due to electrolyte abnormalities, according to an article, Is Bowel Preparation Before Colonoscopy a Risky Business for the Kidney? published in MedScape CME.

OSPs are saline laxative solutions that work by drawing liquid from the body into the colon, which can cause severe hydration. Hydrating during use is optimal, but isn’t always the answer to keeping patients safe.

All patients who take the standard dose of OSP will develop hyperphosphatemia, an electrolyte disturbance in which there is an abnormally elevated level of phosphate in the blood. Patients with increased gastrointestingal absorption of phosphate or decreased renal excretion may develop severe hyperphosphatemia. Fatal cases of hyperphosphatemia have been reported inpatients receiving more than the standard dose of OSP and in those with renal failure.

All patients will also experience another electrolyte imbalance called hypocalcemia, or low serum calcium levels in the blood. Elderly patients are particularly prone to the condition.

A third type of electrolyte disturbance is hypokalemia, a condition in which the concentration of potassium in the blood is low. Potassium is essential for many body functions including muscle and nerve activity. A serious increase or decrease of potassium may promote heart arrhythmias.

Mild hypernatremia, or elevated sodium levels known also as dehydration, is common after OSP use, particularly in the elderly. Severe elevations of sodium can lead to seizures, coma and even death. At least two patients have experienced hyponatremia, or abnormally low sodium levels in the blood, following use of OSP, likely caused by excessive free water intake.

The MedScape CEM summary advises health care professionals: “In addition to educating patients about the possibility of renal damage, physicians should routinely watch for considerable weight loss during bowel preparation and correct the fluid deficit as needed. Carrying out a renal function panel, which includes serum phosphorus level, is prudent after colonoscopy. Alternative bowel cleansing agents are needed because calcium phosphate precipitation is inevitable after OSP use even in the normal kidney.”

SOURCE: Fleet Attorney › Bowel cleanser blamed for renal failure, electrolyte abnormalities

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

The colon hydration is administered by a trained technician in a private room at a spa and takes about 45 minutes. During that time, the patient lies on a table on his back and sides. The method offers a more soothing environment than a hospital setting with less discomfort than the traditional method. Advocates say this makes colon hydration much easier to handle than drinking large doses of laxatives and staying at home, near the bathroom.

Colon hydrotherapy may catch on with more hospitals and physicians, especially since many of the products used to cleanse the bowel prior to colonoscopy have fallen under a black box warning by the Food and Drug Administration (FDA) for causing serious kidney injury called acute phosphate nephropathy in some patients who used oral sodium phosphate products (OSP) for bowel cleansing.

The prescription OSP products in question include Salix Pharmaceuticals’ Visicol and Osmo Prep. The FDA also raised serious concerns over over-the-counter OSP products, including Fleet Phospho-soda made by C.B. Fleet. Shortly after the FDA warning in December 2008, C.B. Fleet pulled its over-the-counter products from the market.

SOURCE: Fleet Attorney › Colon hydration offers alternative to OSP for bowel prep

Currently, C.B. Fleet faces 38 lawsuits that allege the pharmaceutical company did not do enough to warn consumers and health care providers of the risk of serious kidney injury when using its products. The lawsuits were consolidated last week into one federal court to speed the pretrial process.

C.B. Fleet chief scientific officer Chris McDaniel says several thousands of cases of the company’s OSP products have been returned to the company’s Lynchburg, Virginia, headquarters. The company contends that the products are still safe if used as directed, in low doses as a laxative or in higher doses for bowel cleansing prior to procedures such as colonoscopy. In larger doses, the labeling says consumers should drink at least 72 ounces of water to avoid dehydration during use over two days. It also warns individuals who had kidney problems not to use the solutions.

“Fleet’s priority is to ensure the safety of our customers and consumers in general,” McDaniel said. “… We would have to consider whether we felt comfortable that the product would be used safely and according to the labeling that we put out with the product.”

Source: The News & Advance

SOURCE: Fleet Attorney › C.B. Fleet wants to put recalled products back on market

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

The colonoscopy has been considered a gold standard in the detection of ulcers, colon polyps, tumors, and areas of inflammation or bleeding. During a colonoscopy, a thin, flexible tube called a colonocsope with a video camera attached at the end is inserted into the rectum and colon, which allows your doctor to look at the lining of the large intestine.

During the colonoscopy, doctors can collect tissue samples, and abnormal growths, like polyps, can be removed. During the screening tests, doctors can check for cancer or precancerous cells in the polyps collected from the colon or rectum.

Before having a colonoscopy, patients must clean out their colons. A clear liquid diet is ordered and prescription or over-the-counter medications are usually taken to help loosen the stool and encourage elimination.

The procedures are extremely beneficial, but patients should be aware of some risks associated with the bowel-clearing products often used to prior to colonoscopies. Two prescription oral sodium phosphate (OSP) products from Salix Pharmaceuticals – Visicol and Osmo Prep – recently fell under a black box warning by the Food and Drug Administration (FDA) after reports of a serious form of kidney injury in patients who had used the products.

The FDA expressed similar concern over over-the-counter OSP solutions, such as Fleet Phospho-soda and Fleet Accu-Prep, that are often used at higher doses to cleanse the bowel before colonoscopies. As a result, maker C.B. Fleet has pulled those products from the shelves, making them only available by prescription.

You should discuss any concerns with your doctor.

Sources:
American Cancer Society
WebMD

SOURCE: Fleet Attorney › Colonoscopies beneficial for finding cancer early

A clean and productive colon is key to preventing non-digestible bacteria and toxins that linger in the intestinal wall from reabsorbing into the body. That means, for optimal health one should eliminate waste two to three times a day – or within six to 18 hours after every meal.

The best way to get things moving? A healthy plant-based diet high that’s high in fiber. This, too, helps reduce one’s risk of heart disease, cancer, diabetes and “other 21st Century diseases,” according to Alive, without the discomfort of colon cleansing treatments and the threat of serious complications.

“Eating the right foods can clear your colon of debris,” according to Alive. Plant-based foods are the best pick. Choose from vegetables, fruits, beans, seeds, nuts and whole grains that are high in fiber. A high-fiber diet contains plenty of non-digestible product that sweeps through the colon and naturally cleans it out.

That sweeping motion massages and exercises the intestinal tract, which stimulates the peristalsis. It also retains water, which helps to soften stools, making them easier to pass. Foods with both soluble and insoluble fiber are best for the colon and include items such as flax seed and oats.

Most people only consume 10 grams of fiber a day, but experts recommend between 20 to 35 grams for optimal health. To increase your fiber intake, aim to have five or more servings of fruits and vegetables and six or more of whole grains every day.

SOURCE: Fleet Attorney › High fiber diet is safest way to clean colon