› $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 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.
The U.S. Preventive Services Task Force, a government-appointed, independent panel of doctors and scientists, raised quite a ruckus with its recommendations on the frequency of mammograms and pap smears, bucking the American Cancer Society’s recommendations by suggesting that fewer screenings were necessary for otherwise healthy women. But the task force’s opinions on colonoscopies mirror those of ACS with at least one small exception – limiting colorectal exams for patients 75 years and older.
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.
A new study presented at the American College of Gastroenterology’s 74th Annual Scientific Meeting in San Diego, Calif., places new emphasis on the importance of adequate bowel preparation prior to colonoscopies. The news comes as clinicians are evaluating new bowel preparation solutions to replace popular ones that were pulled from the market or given a black box warning by the Food and Drug Administration (FDA).
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.
Most people dread colonoscopies. Not only does the procedure, which involves a physician running a flexible tube through your colon and intestines, sound uncomfortable, the prep can be a real pain in the you-know-what. This is one reason why, when your doctor orders a colonoscopy, you’ll want to be sure you cleanse your bowel thoroughly and effectively to ensure that your doctor has a clear view of your colon. If not, you may have to repeat the procedure and the prep along with it.
To hear your doctor recommend a “colonoscopy” can send chills down most peoples’ spines. The procedure, which involves a doctor sending a little camera fixed to the end of a flexible tube through the colon and into the intestines, can make even the strongest folks a bit uncomfortable. Some even fear that the procedure itself can cause harm. One study hopes to put those fears into perspective.
Many physicians who perform colonoscopies are beginning to ask their patient for a second cleansing of the bowel in the wee hours before their procedures to ensure the bowel is clean and reduce the need for a redo.
