› $150,000,000 verdict in personal injury case
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 of the hottest topics in nephrology over the past few years has been the epidemiologic and histopathologic studies that suggest a link between oral sodium phosphate (OSP) colonoscopy preparations and a serious form of kidney injury known as acute phosphate nephrology, according to The Renal Fellow Network.
As more cases of the condition were reported to the Food and Drug Administration (FDA), the agency last December issued a black box warning on prescription brands of OSP, such as Visicol and Osmo Prep. C.B. Fleet, makers of over-the-counter OSPs, also pulled their products from store shelves. While the Fleet products were deemed safe when taken in low doses as a laxative, Fleet had recommended doctors to tell their patients to use the over-the-counter OSPs in higher doses to prep the bowel prior to colonoscopies.
A study by a group of Italian researchers shows that virtual colonoscopies that use computer tomography scans are almost as effective at detecting tumors and precancerous lesions as standard colonoscopies, which requires threading a camera through the colon. The study, published in The Journal of the American Medical Association, suggests that the new procedure may offer an alternative to people who are too embarrassed or afraid to undergo a standard colonoscopy.
The Food and Drug Administration (FDA) black box warning on oral sodium phosphates (OSPs) came late last year, but as early as 2003, doctors were beginning to make the link between OSP pills and solutions used to clear the bowel before colonoscopies and serious and permanent kidney injuries. As more and more reports of kidney damage and even complete kidney failure began to pour in to the FDA, the agency finally issued a mild warning in 2005. The black box warning on prescription OSP products would come three years later, after 21 more reports of serious kidney injuries. Soon after that FDA warning, C.B. Fleet quickly pulled its over-the-counter OSP products off the market.
Internet commercials for colon cleansing products featuring the images, names and voices of Oprah Winfrey and her friend Dr. Oz are a hoax, says Winfrey and Oz, and they have filed a lawsuit in New York Federal Court to take the ads down, according to TMZ. The lawsuit claims the company is trying to cash in on the false premise that the products have been tested or recommended by Winfrey and/or Oz when they, in fact, have not. Winfrey and Oz claim the company, which sells products such as Colon Pro Cleanse, Power Colon Cleanse and Colon Max, “turn out to be credit card scams or other fraudulent schemes.”
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.
While overall colorectal cancer rates are steadily decreasing, colorectal cancer rates among younger patients are on the rise, according to data collected from the 13 Surveillance, Epidemiology, and End Results (SEER) cancer registries nationwide and studied by the American Cancer Society.
A 62-year-old woman preparing for a colonoscopy followed her doctor’s orders and took a large dose of an oral sodium phosphate (OSP) solution to cleanse her bowel before the procedure. It wasn’t an unusual order. Many physicians either prescribe OSP pills or solutions for their patients or recommend over-the-counter OSP products. However, the patient’s kidneys began to fail. Doctors were able to partially resolve the problem, but the woman was left with stage 4 chronic kidney disease.
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.
