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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“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

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

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

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

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

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

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

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

Many colon cleansing products claim to produce rapid weight loss, but studies have shown that the weight loss from colon cleansing is from fasting and water loss, not the melting away of fat that would be most beneficial. Along with water loss, Endyke says, “is a risk of electrolyte imbalances, dehydration, and a weakening of the colon muscle from stimulant laxatives, resulting in a dependence on the product for regular bowel movements.”

In some cases, use of colon cleansing products can be dangerous to your health. Earlier this year the Food and Drug Administration (FDA) issued its sternest safety warning for prescription oral phosphate drugs used to cleanse the bowel before procedures such as colonoscopies after receiving numerous reports of a rare but serious form of kidney failure, known as acute phosphate nephropathy or nephrocalcinosis, among patients who used the drugs. The prescription drugs that fell under the warning include Visicol and OsmoPrep.

That warning translated to a concern about over-the-counter laxatives such as Fleet Phospha-soda made by C.B. Fleet. While considered safe for use in low doses to treat occasional constipation, the products have been recommended for use in larger doses by doctors for patients prior to procedures. Colon cleansing enthusiasts have also turned to the products, and the FDA has raised concerns about the safety of those products. As a result, C.B. Fleet has pulled those products from store shelves and has made them available by prescription only.

Endyke says the body has an elaborate defense and removal system that involves not only the gastrointestinal system but also the skin, immune system, kidneys and liver that work to ride the body of natural and synthetic chemicals we ingest daily. Her suggestion for keeping your colon clean – “eating several fruits and good portions of vegetables, as well as cereal fibers, and whole grains daily.”

Source: Taunton Daily Gazette

SOURCE: Fleet Attorney › Colon cleansing products may be hazardous to your health