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

“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

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 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

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 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