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

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

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

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

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

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 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

In December 2008, the Food and Drug Administration (FDA) issued a black box warning on prescription OSP products Visicol and Osmo Prep made by Salix Pharmaceuticals after numerous reports of a serious form of kidney injury known as acute phosphate nephropathy had been reported in patients following the use of the products. The FDA also expressed equal concern over the use of over-the-counter OSP solutions such as Fleet Phospho-soda and Fleet Accu-Prep. As a result of the warning, C.B. Fleet issued a recall of its over-the-counter OSP solutions.

Since the FDA issued its first alert in May 2006 about the potential risk of acute phosphate nephropathy in patients who used OSP products, steps have been taken to warn doctors of the potential risks in using OSP products. The warning also was added to a consensus document on bowel preparation issued jointly by the American Society of Colon and Rectal Surgeons, the American Society of Gastrointestinal Endoscopy, and the Society of American Gastrointestinal and Endoscopic Surgeons.

“Hopefully this will lead to increased awareness of the risk factors for (acute phosphate nephropathy) and more judicious, individualized selection of bowel purgatives,” the authors write. “Additional prospective studies are needed to more precisely determine the incidence of (acute phosphate nephropathy) so that physicians and patients can make informed decisions regarding the choice of bowel purgative.”

Source: JASN

SOURCE: Fleet Attorney › Thousands could be injured each year by OSP bowel cleansers

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