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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.
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.
The American Society of Nephrology (ASN), a group that leads the fight against kidney disease in the U.S., holds its annual meeting and scientific exposition next week as part of ASN Renal Week, October 27 – November 1, 2009. The national Renal Week was originally formed as a way to disseminate information on new advances in the science of nephrology. Since then, the educational activities have greatly expanded to meet the needs of both practicing nephrologists and renal scientists.
Each year, more than 13 million patients suffer from acute kidney injury, of which more than 30 percent die. The prevalence of kidney injury has risen to epidemic proportions. Over the past 60 years, little progress has been made to improve the statistics of this condition. But Denmark-based company BioPorto Diagnostics has developed a groundbreaking test called NGAL that can diagnose acute kidney injury early, adding valuable time for doctors to take proactive steps at an early stage that will prevent kidney injury from turning into the very dangerous state of kidney failure.
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.”
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