What is a Virtual Colonoscopy?

If you are scheduled for a colonoscopy, you may want to ask your doctor whether you should have a traditional or a virtual one.

A colonoscopy is an exam that looks at the inside of the colon, which is a section of the large intestine. The test is used to detect abnormalities such as polyps, or cancer. It can also be used to diagnose causes of bleeding, diarrhea or chronic stomach pain.

For both the traditional and virtual exam, much of the preparation is similar. In order to be effective the colon must be clear of any bowel. A day or two before the exam, you will perform a bowel cleansing by using an enema or laxative. If you used an oral phosphate solution (OSP) such as Fleet, Osmoprep or Visicol for bowel cleansing in the past, you should be aware that some patients have suffered bowel prep renal failure (kidney damage) caused by these products.

The bowel cleansing solution, in addition to a liquid diet, flushes the bowels so the colon can be seen during the exam.

In a traditional exam, the doctor will insert a long flexible tube called a colonoscope into your colon through your anus.

The colonoscope has a camera that provides an image of the colon on a monitor that the doctor can view in real time. During the exam, the doctor can remove polyps or collect samples for biopsies.

While a traditional colonoscopy can be performed in a doctor’s office or clinic, a virtual colonoscopy is usually performed in a hospital where a CT scanner or MRI unit is located.

In a virtual colonoscopy, a thin, short tube is inserted in the anus to expand the colon with air. You will lie on a table that passes through one of the two imaging machines, which will produce cross-sectional pictures of the colon. For an MRI, a contrasting fluid will be inserted into the rectum to help highlight areas of the colon. The resulting computer generated images will provide three-dimensional views that can be studied for abnormalities.

When deciding between the traditional and virtual colonoscopies, each has advantages and disadvantages.

Traditional colonoscopies require anesthesia, but the colonoscope can remove polyps and collect samples at the time of the exam.

Virtual colonoscopies provide clearer images, but cannot detect pre-cancerous polyps smaller than 10 millimeters. Sedation is not required, and the exam takes less time. Since virtual colonoscopies are a newer technology, they are not as widely available, and may not be reimbursed by all insurance plans.

If you or your loved one has experienced kidney damage or nephrocalcinosis after using Visicol, Osmoprep or Fleet bowel prep please contact us to discuss your legal rights and one of our Phospho soda lawsuit attorneys will go over the process of bringing a claim.

Colonoscopies are examinations where doctors insert a long, flexible tube into the colon through the anus. A camera is attached to the tube, which allows doctors to see what the camera sees, on a monitor. Colonoscopies are frequently used to check for polyps and colon cancer. Doctors recommend that adults begin receiving regular colonoscopies as part of cancer screening after age 50.

But before you get ready to put on the exam gown, there are some questions you should ask the doctor first.

1. How long has he been performing colonoscopies? How often does he do them? Experts suggest that experienced doctors perform at least five procedures per week.

2. Ask your doctor to describe the procedure, and how long each portion takes. Although the insertion of the colonoscope and the examination are important, another critical part is when the colonoscope is being removed from the colon. This is the time when many polyps or abnormalities can be found. According to the New England Journal of Medicine, doctors who took six minutes to remove the colonoscope from the colon found more polyps than those who took less time.

3. Describe the preparation for the colonoscopy. In order to see clearly inside the colon, it will need to be flushed. Doctors will typically suggest a strong laxative or enema, along with a liquid diet, in order to clean the bowels. Doctors no longer suggest using the oral phosphate solution (OSP) Fleet Phospho-Soda as a bowel cleanser because its use has led to serious kidney injuries in some patients.

It is essential to follow the doctor’s orders on drinking clear liquids when using the bowel cleanser to avoid dehydration.

4. Should regular medications be taken the day of the colonoscopy? Make sure you ask whether you should take your regular medications prior to the colonoscopy. Some drugs may interact with medications given during the procedure. You will most likely be given a sedative and a pain reliever before the exam.

5. How long will you be at the hospital, clinic or office? Because you will be recovering from a mild anesthesia, you will need to have arranged for a ride home.

6. When will you get the results of the colonoscopy? Some results may be known during the colonoscopy. During the procedure, doctors can remove polyps, cauterize to stop bleeding and collect specimens for biopsies. Full results from the colonoscopy are generally back within a week.

If you or a loved one has been affected by kidney damage after using Fleet Phospho-Soda, contact us. We represent Fleet recall clients on a contingency basis, which means there are no legal fees unless we win compensation on your case. If you have questions or would like a free no-obligation case review, please call toll free or fill out our short online contact form for the latest Fleet lawsuit news.

Too often, we wait until we have a more serious medical condition before we are willing to make better decisions for our health. But with some simple steps, we can improve both overall health and the wellbeing of specific organs. Take the colon, for instance. The colon, or large intestine, is the last part of the digestive system. Its main role is to eliminate waste from the body. Here are ways to keep it functioning efficiently.

1. Eat well. You’ve heard it before, but it’s true: diets high in fiber are good for you. That is especially true when it comes to the health of your colon. Foods with a lot of fiber, such as vegetables and fruits, provide vitamins and minerals. But they also contain portions that cannot be absorbed by the body. This provides roughage, which helps move material efficiently through the digestive tract. When the body’s wastes moves efficiently, it can help prevent problems like constipation, hemorrhoids, irritable bowel syndrome and diverticular disease.

Calcium has also been shown to improve colon health. A recent study indicated that people who ate a diet containing a large amount of calcium reduced their risk of colon cancer. Researchers believe that calcium may reduce the growth of abnormal cells in the digestive tract.

As with any healthy eating plan, it is helpful to reduce the amount of high fat proteins and processed foods.

2. Be active. A study published earlier this year showed that people who exercised reduced their risk for colon cancer. Participants in the study who were physically active were 24% less likely to develop colon cancer, regardless the type of exercise. Another study showed that even for those who were in remission from colon cancer, exercise reduced their risk of recurrence.

3. Schedule regular colonoscopies. If you are 50 or over, doctors recommend that you have a colonoscopy every 8 – 10 years. While many people are hesitant to schedule this exam, it is a very good way to find polyps and pre-cancerous cells. For some people, the preparation for the exam is the hardest part.

In order to have a clear view of the colon during the colonoscopy, the intestinal area needs to be clear of any bowel. Prior to the exam, patients are instructed to use a laxative, enema or bowel cleansing solution to flush the bowels. Patients are cautioned not to use an oral phosphate solution (OSP), particularly Fleet Phospho-Soda, which has caused kidney damage in some patients.

Simple steps such as diet, exercise and regular exams can help make sure your colon and the rest of your body stay healthy.

If you or a loved one has been affected by kidney failure after using Fleet Phospho-Soda, contact us. We represent Fleet lawsuit clients on a contingency basis, which means there are no legal fees unless we win compensation on your case. If you have questions or would like a free no-obligation case review, please call toll free or fill out our short online contact form and a Fleet recall attorney will help explain your legal options.

Frequently Asked Questions about Fleet Kidney Injuries

Many kidney diseases can occur slowly over a period of years, but a kidney injury can occur suddenly, leaving patients with the need for information, fast.

Here are answers to some of the most frequently asked questions.

What Do the Kidneys Do?

The kidney is a bean shaped organ located near the small of the back. People are usually born with two kidneys, with the right kidney positioned slightly lower than the left.

The kidney provides a filtering system that cleans the blood of toxins and waste as the blood passes through the body. The kidney produces a hormone called erythropoietin or EPO, which stimulates the bone marrow to produce red blood cells. By excreting excess salt, the kidney also helps regulate blood pressure.

What Causes an Injury?

Kidney injuries can happen as a result of an accident, like a car crash or a hard tackle on the football field. It can come from a knife or gunshot wound. It can also occur from a puncture during a medical procedure, or from the use of certain products. One specific type of kidney injury, acute phosphate nephropathy, has occurred when patients ingested Fleet Phospho-Soda, an oral enema, in preparation for colonoscopies.

What are Symptoms of Fleet Kidney Damage?

Depending on the severity of the injury, symptoms may be subtle or extreme. They may come on gradually over a period of weeks, or suddenly. At first, people may notice tiredness, lethargy and sleepiness. Because the kidney is unable to clean the blood’s toxins, the toxins stay in the body causing swelling initially in the legs and feet.

Patients may get headaches, lose their appetite and experience nausea or vomiting.

In extreme cases, a person with an untreated kidney injury may experience confusion, coma and even death.

What Can I Do About an Injury?

If you think you have a kidney injury, see your doctor immediately. She can perform tests that determine the kidney’s function and narrow down the problem. The kidney can heal from some injuries, but in some circumstances, it cannot function at the level your body needs.

What Happens if My Kidneys Cannot Recover Fully?

While your doctor can advise you on your specific options, many people who have kidneys that cannot function effectively use an artificial method of cleaning the blood, called dialysis.

Two types of dialysis are typically used. In hemodialysis, blood is extracted from the patient gradually from a needle in his arm. The blood flows into a dialysis machine where it is cleaned and then sent back into the body through another needle. In peritoneal dialysis, a solution is inserted into the patient’s abdomen through a catheter, and remains there for several hours. While it is there, it absorbs toxins through the abdomen wall. At the end of the waiting period (dwelling time), the solution is removed. If neither type of dialysis is possible, your doctor may also recommend a kidney transplant.

If you or your loved one has experienced kidney failure after using Fleet Phospho-Soda please contact us to discuss your legal rights and one of our Fleet class action lawsuit attorneys will go over the process of bringing a claim.

Fleet Kidney Damage due to Bowel Cleansing Preparation

During a colonoscopy exam, doctors will insert a long thin tube (colonoscope) with a small camera attached in the patient’s colon through the rectum. In order to see the colon clearly, it must be clear of any bowels. Patients preparing for a colonoscopy use a bowel cleansing solution one to two days prior to the procedure.

Studies have shown that a number of patients who used a particular bowel-cleansing laxative called Fleet Phospho-Soda developed acute kidney injury. This condition, which is called acute phosphate nephropathy, occurred when the sediments from the oral laxative remained in the kidney, hindering the kidney’s ability to do its job of filtering toxins from the blood. As a result, the toxins re-circulated through the body and the kidneys began to fail. Patients suffering irreversible kidney damage required dialysis or transplant.

The FDA has issued a warning about Fleet Phospho-Soda, and the company has removed it from stores as an over the counter preparation. The FDA now recommends that patients do not use any oral phosphate solution (OSP) for bowel cleaning before a colonoscopy.

Cleanliness of Colonoscope

The colonoscope can take pictures of the inside of the colon, which a doctor can view on a monitor during the exam. The colonoscope can also collect samples for biopsies, remove polyps or cauterize areas to stop bleeding. But questions arise on whether all of the parts of the instrument can be thoroughly cleaned. Over the last few years, a number of hospitals have notified patients that they may be at risk for infectious diseases such as hepatitis C, which was transferred from one patient to another via improperly cleaned colonoscopes.

Other Complications

After the procedure, patients may feel bloating, which comes from the insertion of air into the colon during the procedure. This feeling should subside within a few hours. Patients may also experience some bleeding, especially if a polyp was removed. A rare but serious complication occurs when the colonoscope punctures the colon or rectal wall. When this happens, surgical repair is required.

For more information please call us or fill out our online contact form and a Fleet Phospho-soda laxative attorney at Fields Law Firm will explain your legal options.

Acute phosphate nephropathy is a serious kidney injury. It’s called “acute” because it can develop suddenly. It is caused when one or both kidneys are unable to filter toxins from the blood efficiently, and Fleet kidney failure can occur.

What Causes Acute Phosphate Nephropathy?

Studies have shown that people who use a specific solution in preparation for a colonoscopy have developed acute phosphate nephropathy. Fleet Phospho-Soda has been commonly suggested as an over the counter bowel cleansing solution for patients to take before having a colonoscopy. Patients were instructed to take the oral solution, which produced loose stools and diarrhea. This flushed the colon and made it easier for doctors to see inside the colon during the colonoscopy exam.

When patients ingest Fleet Phospho-Soda, it travels to the kidney to be filtered. However, researchers believe that the kidney is unable pass it from the body through urine, and the phosphates remain in the kidney. This hinders the filtering system, which causes decreased kidney function or kidney failure.

Patients developed acute phosphate nephropathy anywhere from a few hours to several weeks after using the bowel cleansing solution.

Who is Most Likely to Be Affected by Acute Phosphate Nephropathy?

Some patients who were affected by this kidney injury had no underlying medical issues, but some did.

Patients with a higher risk were 55 years old or older, had a history of kidney problems or colitis. Some patients who were dehydrated or who were taking medications such as diuretics, medicines to treat blood pressure or anti-inflammatory drugs were also more susceptible.

What are Symptoms of Acute Phosphate Nephropathy?

Because the kidneys do so much for the body: cleaning the blood, helping to regulate hormones and blood pressure, when they don’t work, it affects the entire body.

Common symptoms include:

Tiredness
Sleepiness
Lethargy
Decrease in urine
Swelling of legs or feet

How Do You Treat Acute Phosphate Nephropathy?

Treatment options will depend on the severity of the kidney injury. If you are diagnosed with acute phosphate nephropathy, your doctor will be your best source for options. Treatment may include short or long term dialysis or kidney transplant.

If you have been affected by acute phosphate nephropathy, you may be entitled to legal action. A Fleet lawsuit attorney at Fields Law Firm can help you determine your legal options. We are currently helping individuals and families bring individual claims against the manufacturer for kidney damage.

What to Expect From a Colonoscopy

Have you been to the doctor lately, and she suggested you have a procedure called a colonoscopy? Perhaps you’ve had unusual stools, chronic diarrhea or unexplained stomach pain. Or maybe you’re age 50 or over and this is a routine test.

For whatever reason, if you are scheduled for a colonoscopy, here is what you can expect from the procedure.

What is a Colonoscopy?

A colonoscopy is a test that looks inside the colon, which includes the large intestine and the rectum. It can be done in a doctor’s office, clinic or hospital, and uses a long flexible tube called a colonoscope, which is inserted in the rectum. The colonoscope has a tiny camera attached, which allows doctor to see images from the camera on a monitor during the exam.

How do I prepare for a colonoscopy?

Typically the day or two before the procedure, you will be given a solution that will have a laxative or enema effect, in order to clean out the bowels. The solution will result in loose stools and perhaps diarrhea, so you’ll want to stay home where you can relax and be comfortable.

Although doctors may offer various suggestions of solutions, be sure to steer clear of Fleet Phospo-Soda. This is an oral solution that may have caused kidney damage in some patients who used it prior to a colonoscopy. Ask your doctor for other options.

During the bowel cleansing period, and up until the exam, you will be on a clear, liquid diet. After the exam is complete, you’re typically allowed to resume eating your normal food.

When you schedule your exam, it’s a good idea to arrange for someone to pick you up afterwards.

What happens during the exam?

When you arrive for your colonoscopy, you will change into a gown and will be given a mild sedative through an IV. Most patients remain awake, but relaxed during the exam. Your vital signs (heart rate, breathing, etc.) will be monitored throughout the procedure. You’ll lie on the exam table, typically starting on your left side. The doctor will insert the colonoscope and will monitor it as it travels through the colon. The colonoscope itself is about three feet long and thin, about 1 inch wide. The doctor will slightly inflate the colon with air as the tube travels along. You may be asked to adjust your position to make it easier for the colonoscope to navigate the turns in the colon.

During the exam, the doctor can take pictures of the colon, collect tissue or samples and remove small growths. The doctor will then slowly remove the tubing, checking again for any abnormalities.

The exam may take 30 minutes to an hour.

Afterwards, you will be allowed recovery time. If this was done as an outpatient procedure, you may be released. Results from the colonoscopy are usually available within a week.

Free no-obligation consultation for filing a Fleet Phospho-Soda Lawsuit. There is never any charge to speak to one of our attorneys. If you or a family member has suffered kidney damage after using Fleet OSP products please contact us today.

A colonoscopy is a medical procedure used to check the large intestine for polyps and abnormalities. To prepare for the colonoscopy procedure, affected patients were instructed to use a bowel cleansing solution called Fleet Phospho-Soda, which is an oral sodium phosphate (OSP) once available over the counter.

When used as directed, Fleet Phospho-Soda flushed the colon of feces, making it easier for doctors to see inside. However, in the days and weeks following the bowel cleansing, some patients experienced a serious injury to their kidneys, called acute phosphate nephropathy. This led to decreased kidney functions, and, in some cases, the need for dialysis or transplant.

The kidney acts as a filter for the body, screening out toxins in the blood. Think of boiling a pot of spaghetti in hot water and then draining it in a colander. The colander will filter out the spaghetti, allowing the water to flow out cleaner. A healthy kidney works like the colander—it can get rid of the spaghetti-or toxins in the blood. The toxins are then taken out of the body through urine.

Researchers believe that when patients used Fleet Phospho-Soda, debris from the solution built up in the kidney. As a result, the filtering system in the kidney (called the nephrons) was not able to filter blood effectively, and so those toxins were re-circulated in the body.

In addition to filtering toxins, the kidney also helps produce hormones that regulate blood pressure, produces a hormone that helps make red blood cells and balances the body’s fluid content.

Because of the kidney’s vital role in the body, when it’s not functioning at an acceptable level, symptoms can be pervasive, including tiredness, shortness of breath, decreased urine output and swelling in the legs. More serious symptoms include confusion, seizures and coma.

Some kidney failures can be reversed, but at advanced stages, kidneys may not be able to recover their full functionality.

The Food and Drug Administration warned that Fleet Phospho-Soda should not be used as an over the counter bowel cleansing solution, and Fleet has complied.

If you or your loved one has experienced kidney failure after using Fleet Phospho-Soda please contact us to discuss your legal rights and one of our Fleet colonoscopy lawsuit attorneys will go over the process of bringing a claim.

Fleet Phospho-Soda, which is a solution used to clean the bowels prior to a colonoscopy, has caused serious kidney damage in some users. The FDA issued a warning of these dangers, and Fleet’s manufacturer, C.B. Fleet, has issued a recall of the Phospho-Soda from drugstore shelves. The solution is now available only by prescription.

Fleet Phospho-soda was originally sold as an over the counter oral solution and was recommended to patients to use the day before a colonoscopy. Patients were instructed to mix the powder with a clear liquid and drink it, while following a clear liquid diet that day. Patients may have been instructed to take one or more doses at specific intervals.

By using Fleet Phospho-soda, patients lost fluid through bowel movements, which effectively flushed the bowels and made it easier for doctors to see the colon more clearly to check for polyps or any abnormalities.

While the treatment worked for this purpose, some people who used Fleet Phospho-soda have had a serious kidney injury, leading to decreased kidney function, dialysis and transplant.

Researchers have examined the connection between oral sodium phosphates (OSPs) and kidney damage for several years, and believe that the fluctuation of fluid during the bowel cleansing may be one cause of the Fleet kidney damage.

Although some of the affected patients had underlying medical issues, others did not. Because people who ingest the treatment lose a lot of fluid through the bowel cleansing, they are instructed to replace the fluid with clear liquids. The Food and Drug Administration (FDA) says it is possible that some patients may not have done this effectively and became dehydrated.

Some patients developed a serious kidney injury called acute phosphate nephropathy, which can occur when calcium-phosphate crystals enter the area of the kidney that filters blood (renal tubules) and impairs the kidney’s function.

Symptoms of the injury appeared one day to several weeks after the procedure, and included lethargy, decreased urine, nausea and swelling of the legs.

Acute phosphate nephropathy can be treated, but the damage cannot always be reversed. If the damage to the kidney is too great, the organ is unable to function properly. At this point of kidney failure, the patient will need to consider additional treatment options such as dialysis or a kidney transplant.

If you or a loved one has been affected by kidney damage after using Fleet Phospho-Soda, contact us. We represent Fleet lawsuit clients on a contingency basis, which means there are no legal fees unless we win compensation on your case. If you have questions or would like a free no-obligation case review, please call toll free or fill out our short online contact form.

Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) – Healthcare Professional Sheet text version

FDA ALERT [12/11/2008]: FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSPs or they did not drink sufficient fluids after ingesting OSP.

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. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OSPs. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued.

Individuals who appear to have an increased risk of acute phosphate nephropathy following the use of OSPs include persons: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).

As a result of new safety information received, FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products.

FDA acknowledges that OSP products, in addition to use for bowel preparation, have a long history of safe use as non-prescription products as laxatives (i.e. for relief of constipation) and accordingly, they will continue to be available over-the-counter for this use. However, in light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional. FDA intends to amend the labeling conditions for OSP products available in the OTC setting to address this concern with bowel cleansing use and to improve the safe use of OSPs that are available over-the counter. FDA’s amendment to remove the professional labeling for bowel cleansing for these OSPs available over-the-counter will be published in a future Federal Register notice.

This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.
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To report any unexpected adverse or serious events associated with the use of these drugs, please contact the FDA MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.

Information for healthcare professionals to consider when ordering an OSP bowel preparation for their patients:

Acute phosphate nephropathy presents as acute kidney injury with minimal proteinuria and a bland urine sediment in patients recently exposed to OSP. Renal biopsy typically reveals acute and/or chronic renal tubular injury (depending on time to diagnosis), calcium-phosphate crystal deposition in the distal tubules and collecting ducts, and no other pattern of histological injury.

When prescribing OSPs for bowel preparation, healthcare professionals should consider the following points:

• Provide easy to understand instructions to the patient about how to prepare for the procedure, and tell them what symptoms to be aware of in order to help them recognize, and possibly mitigate the risk of acute kidney injury.
• Instruct patients of the need to drink sufficient quantities of clear fluids before, during and after bowel cleansing. There are publications suggesting that use of an electrolyte or carbohydrate-electrolyte replacement solution may help decrease the electrolyte abnormalities and hypovolemia associated with OSP bowel cleansing.
• Avoid exceeding the maximum recommended OSP doses.
• Avoid concomitant use of laxatives containing sodium phosphate.
• Avoid use of OSPs in children under 18 years of age.
• Use OSPs with caution in patients over 55 years of age.
• Use OSPs with caution in patients with dehydration, kidney disease, delayed bowel emptying, or acute colitis.
• Use OSPs with caution in patients taking medicines that affect kidney function or perfusion, such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly non-steroidal anti-inflammatory drugs (NSAIDs).
• In patients who may be at increased risk for acute phosphate nephropathy, including those with vomiting and/or signs of dehydration, obtain baseline and post-procedure labs (electrolytes, calcium, phosphate, BUN and creatinine). For smaller, frail individuals, also monitor glomerular filtration rate.
• Consider hospitalization and intravenous hydration during bowel cleansing to support frail patients who may be unable to drink an appropriate volume of fluid or who may be without assistance at home.

Data Summary

In May 2006, FDA posted on its website an Information for Healthcare Professionals sheet and a Science Paper describing cases of acute phosphate nephropathy associated with the use of prescription and over-the-counter OSP laxatives when used for bowel cleansing. At the time of posting, there were no cases of acute phosphate nephropathy associated with OsmoPrep as it had just been approved. Since that time, FDA has continued to receive adverse event reports and there have been reports in the literature describing OSP-associated acute kidney injury.

Since May 2006, FDA has continued to receive reports of acute phosphate nephropathy with both prescription and products available in the OTC setting. Twenty unique cases of acute kidney injury associated with the use of OsmoPrep were reported to FDA’s Adverse Event Reporting System (AERS) database. The onset of the kidney injury occurred from several hours to 21 days after OSP use. Three of these patients had a kidney biopsy, the results of which revealed acute phosphate nephropathy. Concomitant use of an ACE inhibitor or angiotensin receptor blocker was noted in 11 cases, diuretic use in 6 cases, NSAID use in 4 cases, and 1 patient received a contrast dye. Five cases were reported to be life-threatening and ten resulted in hospitalization. Of these 20 cases, 4 patients required dialysis for an unspecified period of time and one patient died from complications of pneumonia. Nine patients were reported to have renal impairment that continued for at least 2 to 4 weeks; the duration of renal impairment is unknown for 7 patients.

Recently published observational, retrospective studies (see below) attempt to assess the incidence of subclinical (without symptoms) kidney injury after OSP use for bowel preparation. It is not entirely clear how the observations in these studies relate to other cases of acute phosphate nephropathy that become evident because of the development of clinical symptoms which lead physicians to conduct testing. These studies only assess changes in serum creatinine in a cohort of people who received OSP for bowel cleansing, in an attempt to determine whether lesser degrees of kidney injury occur in a population of patients receiving OSP. Brunelli et al. conducted a retrospective, case-control study of outpatients undergoing colonoscopy, comparing those who subsequently developed kidney injury, defined as a 25 percent or > 0.5 mg/deciliter increase in serum creatinine, to those who did not. The Brunelli study found no statistically significant association between acute kidney injury and exposure to OSP, but did find a significant interaction indicating increased risk for kidney injury from OSP in patients who were simultaneously receiving ARBs or ACE inhibitors. The Brunelli study also found that risk factors for the development of acute kidney injury included female gender, heart failure, and diuretic use. In addition, another observational retrospective cohort study by Hurst et al. revealed an increased risk of acute kidney injury, defined as > 50% increase in baseline serum creatinine, in patients undergoing bowel cleansing using OSP products compared to polyethylene glycol or PEG preparations. However, a recent study by Russmann et al. evaluated the risk of impaired kidney function after colonoscopy and revealed that in patients without preexisting kidney disease, the risk of renal impairment, defined as calculated glomerular filtration rate less that 60 mL/minute, after colonoscopy appears to be similar for sodium phosphate and PEG users. There are limitations in the design of all of these studies, such as the lack of a consistent definition of acute kidney injury and the exclusion of patients with baseline serum creatinine values above a threshold value. As a consequence, no definitive conclusions can be drawn and prospective studies are needed to further assess subclinical changes in kidney function.

Under its new authorities provided in the Food and Drug Administration Amendments Act of 2007, FDA is requiring the manufacturer of the two prescription OSP products, Visicol and OsmoPrep to add a Boxed Warning to the labeling for their products and to implement a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of the drugs will outweigh the risk of acute phosphate nephropathy. FDA is also requiring that the manufacturer conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these drugs.

Since these risks are associated with all OSPs used for bowel cleansing, whether they are available by prescription or in the over-the-counter setting, FDA is also taking measures to ensure the safe use of OSPs that are available without a prescription. To accomplish the latter, FDA intends to amend the labeling conditions for OSP products available in the OTC setting to address this concern with bowel cleansing use and to improve the safe use of OSPs that are available over-the counter. FDA’s amendment to remove the professional labeling for bowel cleansing for these OSPs available over-the-counter will be published in a future Federal Register notice.
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Brunelli SM, Lewis JD, Gupta M, et al. Risk of kidney injury following oral phosphosoda bowel preparations. J Am Soc Nephrol 18: 3199-3205; 2007

Hurst F, et al Association of oral sodium phosphate purgative use with acute kidney injury. J Am Soc Nephrol 18: 3192-3198 2007

Markowitz GS, Radhakrishnan J and D’Agati VD. Towards the incidence of acute phosphate nephropathy. J Am Soc Nephrol 18: 3020-3022; 2007

Russman S, Lamerata L, et al Risk of impaired renal function after colonoscopy: A cohort study in patients receiving either oral sodium phosphate or polyethylene glycol. Am J Gastroenterol 102:2655-2663; 2007

Heher EC, et al Adverse renal and metabolic effects associated with oral sodium phosphate bowel preparation. Clin J Am Soc Nephrol 3: 1494-1503; 2008

We represent all Fleets phospho soda recall, Visicol and OsmoPrep clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation case review please call toll free at 1-888-343-5375 or fill out our short online contact form and a Fleet lawsuit attorney will contact you to answer any of your questions.