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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.
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.
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.
Both men and women age 50 and older, and any one regardless of age who experiences problems such as blood in the stool, intestinal pain, internal hemorrhoids, should have a colonoscopy to screen for colon cancer. If caught early, colon cancer is curable, making regular screenings imperative.
An estimated 106,100 people will be diagnosed with colon cancer and 40,870 with rectal cancer this year, according to the American Cancer Society. It is the second leading cause of cancer-related death. But the good news is that the death rate is dropping. One reason is that regular screenings have allowed doctors to find more colorectal cancers sooner, thus making the disease easier to cure.
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