Lawsuits

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

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

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

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

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

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

“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

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

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

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

Brian didn’t follow the advice of a doctor and admits that he later learned that a water-only diet wasn’t the best idea for prepping his bowel for cleansing. A fruit juice diet would have been a better option, he says. But from the looks of it, it appears that the professional cleanse did its job.

Some may choose to go about cleansing through other means, like taking supplements or high doses of over-the-counter laxatives. Whatever your choice, be advised that some products have recently fallen under an FDA warning because of the risk of a rare but serious form of kidney disease associated with oral phosphate products.

The warning was associated with the prescription brand names Visicol and OsmoPrep, but the FDA voiced similar concerns with over-the-counter laxatives such as Fleet Phospho-soda made by C.B. Fleet. While safe in lower doses to treat occasional constipation, the products are not safe at higher doses that are often used for colon cleansing.

Click below to watch the video. The video is not graphic, but may disturb the squeamish. It’s also pretty long, at about 20 minutes run time.

Source: YouTube, DepressingProspects

SOURCE: Fleet Attorney › Colon cleanse video gives a glimpse of what to expect

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