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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
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.
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
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
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
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
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
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
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
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
