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oral sodium phosphates (osp) linked to kidney failure

fda issues highest warning for prescription osp products and additional warnings for over-the-counter osps

On December 11, 2008, the U.S. Food and Drug Administration (FDA) issued a Safety Alert calling for a black box warning to consumers and health care providers that a serious form of kidney injury, acute phosphate nephropathy, had been associated with the use of prescription OSP, namely Salix Pharmaceuticals’ Visicol and Osmo Prep. These products are generally prescribed prior to a colonoscopy or other medical procedure.

The FDA expressed equal concern of the use of over-the-counter (OTC) products such as Fleet Phospho-soda and Fleet Accu-Prep solutions for bowel clearing, though it emphasized that using the OTC products in low doses as a laxative did not pose a risk of acute kidney failure. However, the FDA plans to amend the labeling conditions for OTC OSP products to address this concern with bowel cleansing use.

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.

In response to the FDA’s stern safety warning, C.B. Fleet Company Inc. announced a voluntary recall of its over-the-counter Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System. On February 13, 2009, C.B. Fleet ceased the sale of its Fleet Prep Kit 1 product.

In a news release, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said, “Though rare, these are serious adverse events associated with the use of oral sodium phosphates — both prescription and over-the-counter products.

“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. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products or they did not drink sufficient fluids after ingesting OSP products.”

lawsuit update

As a result of the recent consolidation and settlement of Fleet Phospho-soda cases under MDL 2o66, Beasley Allen is no longer reviewing these cases.

Fleet Phospho-soda kidney damage lawsuits consolidated, settled in MDL

Judge Dan Polster of the United States District Court for the Northern District of Ohio recently issued a settlement order consolidating Fleet Phospho-soda laxative litigation. The order is Oral Sodium Phosphate Solution (OSPS) MDL 2066. The settlement will resolve most cases involving injuries caused by Fleet Phospho-soda. The transfer order, filed June 23, 2009, consolidated 38 actions under Section 1407 in the Northern District of Ohio. The MDL was  assigned to the Honorable Ann Aldrich for coordinated or consolidated pretrial proceedings. According to the order, the Panel on Multidistrict Litigation determined all actions included in the suit share factual questions ... Read More

Too many colonoscopies performed on those at low risk for colon cancer

People considered “low risk” for colorectal cancer are having too many colonoscopies, and not enough patients considered “high risk” for the disease are having timely follow-up procedures, according to researchers with the University of Pittsburgh School of Medicine. There is no debate that colonoscopies are vital for the early detection and treatment of cancers of the colon and rectum. Colorectal cancer is the third most deadly cancer among American men and women. The American Cancer Society recommends people begin regular colon screenings at age 50 or earlier if they have a family history of the disease or are presenting bothersome ... Read More

People should be more proactive with their health

“In the emergency room, I end up diagnosing a lot of cancer,” says Dr. Mylissa Graber, medical director of the emergency department at West Palm Beach’s Good Samaritan Medical Center. “People don’t go to the doctor, don’t follow up on getting their tests done, and show up when (diseases) are pretty advanced,” she said to the Palm Beach Post. That is one reason why colon cancer has become the second leading cause of cancer-related deaths among U.S. men and women combined. Colon cancer is highly treatable if caught early. But symptoms of colon cancer are often unnoticed or nonexistent until ... Read More

Lawsuits citing kidney injury from OsmoPrep commence

Lawsuits began last month for four people who say the prescription bowel cleanser OsmoPrep caused them kidney damage that resulted in dialysis. OsmoPrep, made by Salix Pharmaceuticals, is a type of laxative called oral sodium phosphate, or OSP, used to cleanse the intestines prior to procedures such as colonoscopy. Salix Pharmaceuticals began marketing OsmoPrep in 2006. The drug generated more than $30 million in sales in 2008. 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 ... Read More

Study shows need for thorough polyp removal, continued surveillance

A new study by researchers from the University of Pittsburgh School of Medicine and Epidemiology confirms the need for continued colonoscopy surveillance in patients at risk for colorectal cancer, especially those with a history of precancerous polyps. It also highlights the importance for polyps, especially those that are precancerous, to be completely removed since cancer may develop at the site of polyp removal if residual tissue remains. The study focused on the rate of interval colorectal cancer in patients participating in the Polyp Prevention Trial Continued Follow-up Study, a four-year multicenter, randomized, controlled trial designed to examine the effects of ... Read More

Drinking warm water prior to colonoscopy proves effective

A new study published in the American Journal of Gastroenterology suggests that drinking warm water prior to having a colonoscopy may help the bowel to relax and improve one’s comfort level during the procedure as well as offer more complete results, according to a Reuters Health report. The study, which was conducted by researchers at Sungkyunkwan University School of Medicine in Seoul, Korea, found that when patients drank 2 liters of warm water just prior to a colonoscopy, doctors were able to examine an average of 98.4 percent of large intestine surface. Doctors reported only examining an average of 90.6 ... Read More

Patients with acute kidney injury at greater risk for premature death

People who suffer from acute kidney injury (AKI), a sudden loss of kidney function, are more likely to die prematurely after leaving the hospital even after their kidney function has recovered, according to a study conducted by researchers with the Center for Health Quality, Outcomes, and Economic Research. The data will be published in an upcoming issue of the Journal of the American Society of Nephrology (JASN). The study looked at data from about 83,000 veterans with AKI. More than half of those patients needed dialysis at least temporarily, and many died prior to leaving the hospital. The Center for ... Read More

Blood test to detect colon cancer seeks FDA approval

Yet another biotech company is diligently working to find a safer, less invasive test besides a colonoscopy to detect cancers of the colon and rectum. EDP Biotech Corporation of West Knoxville, Tenn., has announced that it is seeking FDA approval of a blood test to detect colon cancer at its earliest and most treatable stages. Colorectal cancer is the third most common cancer among men and women in the United States, and is among the most deadly of cancers. In an effort to improve those statistics, doctors began recommending that people have regular colon screenings, such as colonoscopies, to look ... Read More

NCI report: new cases of colon, rectal cancer deaths declining

The rate of new colorectal cancer cases and deaths from colorectal cancers has declined, according to a report from leading health and cancer organizations. Colorectal cancer is the third most common cancer among men and women, and the second leading cause of cancer deaths in the United States. The newly released report includes data from the National Cancer Institute (NCI), part of the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), the American Cancer Society (ACS), and the North American Association of Central Cancer Registries (NAACCR). The data shows a 3 percent decrease in new colon ... Read More

Less invasive alternative to colonoscopy set for 2011 clinical trial

A Madison, Wis., company is developing a less invasive way of screening for colon cancer that it hopes will take the place of uncomfortable colonoscopies and increase the number of people willing to be screened for colorectal cancers. Exact Sciences Corp., has developed a DNA-based test that can detect colorectal cancer through a stool sample. Even more convenient than a colonoscopy for the patient, the test can be administered at home and sent to a lab for analysis. The new test can detect more than 50 percent of pre-cancers and 85 percent of cancers, compared to 85 and 90 percent ... Read More