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

Colonoscopies serve an important purpose – identifying colon polyps even before they are cancerous, in some cases virtually eliminating one’s chances of getting colorectal cancer. Because most cancers of the colon and rectum don’t present symptoms until the later stages, when it is most deadly, doctors recommend patients receive regular colon screenings by colonoscopy beginning at age 50 or earlier if they have a family history or are showing suspicious symptoms.

The procedure is generally safe. One of the biggest concerns expressed by patients is colonoscopic perforation (CP), or bowel perforation caused by equipment used during the colonoscopy exam. While CP is an important part of the benefit-harm calculation of colonoscopy, especially those who do not present symptoms, the risk of CP is rare, occurring in only 1 out of 1,700 procedures.

One study pulled data from more than 10,000 patients undergoing either a colonoscopy or flexible sigmoidoscopy at the Faculty of Medicine Siriraj Hospital in Bangkok, Thailand, between January 2005 and July 2008. It found that over that 3.5-year period only 15 CPs occurred among 10,124 patients who underwent the procedure, or 0.15 percent. Variables such as patient gender, emergency endoscopy, anesthetic method, and the specialty or experience of the endoscopist did not seem to play a role in the outcomes. However, patients over 75 years of age and those who received therapeutic endoscopy were at higher risk of CP.

Older patients also are more likely to suffer from a severe adverse reaction to a type of laxative that is either prescribed to patients or sold over-the-counter to cleanse the bowel prior to a colonoscopy. That type of laxative, known as oral sodium phosphate, or OSP, has been linked to a serious form of kidney injury known as acute phosphate nephropathy. Prescription brands of OSP, such as Visicol and Osmo Prep, now carry a black box warning, and over-the-counter OSP products, such as those made by Fleet, have been pulled from store shelves. While older patients and women are at higher risk from kidney injury from OSPs, younger patients have also experienced kidney problems often weeks or months following use of the OSPs.

SOURCE: Fleet Attorney › Study puts colonoscopy risks into perspective

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

“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’