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

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

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

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

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

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

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

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

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

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