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

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

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

“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

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 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 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

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

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