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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.
One year ago this month, the Food and Drug Administration (FDA) issued a black box warning on a common type of laxative known as oral sodium phosphate, or OSP, available both over-the-counter and by prescription. After years of investigation, the FDA finally alerted health care providers and the public of the risk of a serious kidney injury known as acute phosphate nephropathy associated with the use of OSPs.
Let’s face it. There is no comfortable way to prepare for a colonoscopy. You can call it a necessary evil, but colon screenings are necessary for early detection of colorectal cancer for people ages 50 and older, those with a family history, or individuals who are experiencing bothersome symptoms, such as blood in the stool. After all, early detection of precancerous lesions are associated with an up to 90 percent reduction in colon cancer, the country’s second-leading cause of cancer deaths.
Attorney Russell Todd Abney with Beasley Allen Law Firm has filed a lawsuit against C.B. Fleet Company, Inc., on behalf of Mary Little, a resident of Newton County, Georgia, claiming that the plaintiff suffered severe personal injuries as a result of ingesting Fleet’s over-the-counter product known as Fleet Phospho-soda.
Movie stars and celebrities may swear by them, but medical experts agree that colon cleansing should only be done when medically necessary.
“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.”
Could samples of your stool keep you from having a colonoscopy? Researchers at Baylor Medical Center think so. A team of doctors from Baylor pored through stool samples, analyzed long strands of DNA and were able to diagnose gastrointestinal cancers early, according to a report from KARE-TV 11.
Health Canada has ordered manufacturers of over-the-counter oral sodium phosphates (OSP), such as Fleet Phospho-Soda, to either re-label the products to remove any mention of bowel cleansing, or remove the products completely from the Canadian market.
On December 11, 2008, the Food and Drug Administration (FDA) issued a safety alert calling for a black box warning on prescription oral sodium phosphate (OSP) products used to prepare the bowel prior to colonoscopies following reports of a serious form of kidney injury in patients who had taken OSP products.
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.
When the Food and Drug Administration (FDA) issued a black box warning on prescription oral sodium phosphates (OSP) Visicol and Osmo Prep, medications used to clear the bowel before colonoscopies and other procedures, C.B. Fleet also removed its over-the-counter OSP solutions from store shelves. While safe when used in low doses as a laxative, those products, known over-the-counter by such brand names as Fleet Phospho-soda and Fleet Accu-Prep, when used in higher doses for bowel cleansing, have been linked to a serious form kidney injury called acute phosphate nephropathy. Despite the warnings issued here in the U.S., the products are still widely available in countries like Jamaica.
Two studies in the Journal of the American Society of Nephrology (JASN) suggest that at least 50 percent of patients undergoing a screening colonoscopy receive oral sodium phosphates (OSP) to prep their bowel. Which means as many as 7 million of the 14 million Americans who have regular screenings each year are at risk for a serious kidney injury that has been associated with the use of OSP. The article estimates that as many as 1,400 to 7,000 people could be injured each year by the product used routinely for bowel clearing.
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