Bowel Prep & Kidney Problems
In December 2008, the U.S. Food and Drug Administration (FDA) ordered the makers of Visicol and OsmoPrep to include black box warnings on the drugs’ labels regarding acute kidney risks associated with prescription sodium phosphate medications (OSPs). The medications can be taken for bowel prep before a colonoscopy. A March 2009 article in Public Citizen’s “Worst Pills, Best Pills” newsletter highlighted patient reports of acute phosphate nephropathy, a type of serious, acute kidney damage, associated with the use of OSPs.
The FDA has acknowledged similar kidney problems in people who used over-the-counter (OTC) sodium phosphate products as bowel preps, and the FDA has not endorsed the usage of such products for bowel prep. Further, the FDA plans to amend OTC OSP labels to encourage users not to use this product for bowel cleansing. One manufacture of the drug, C.B. Fleet Co., has already announced a voluntary recall of OTC Fleet Phospho-soda products.
Earlier, in 2006, the FDA outlined the risks associated with the use of OSPs for bowel cleansing to healthcare professionals. After the FDA’s report, it has received at least 20 reports of kidney damage associated with the use of OsmoPrep. Of the 20 reported cases, 3 included cases of acute phosphate nephropathy. According to the FDA, the onset of kidney damage varied from several hours up to 21 days after initial usage. In addition, the FDA is not recommending OSPs to be used by children or persons under 18 years old. Further, OSPs should not be used in combination with laxatives that contain sodium phosphate. Caution is also given to persons: over 55; history of dehydration, kidney disease, acute colitis, or delayed bowel emptying; and people taking medications that affect kidney function, i.e., diuretics or NSAIDS.
According to an article published in the the Journal of the American Society of Nephrology, acute phosphate nephropathy is a serious condition in which calcium phosphate deposits build up in the kidney (renal tubules) and can result in permanent kidney function impairment. In fact, persons diagnosed with acute phosphate nephropathy may suffer from permanent impairment of kidney functions. Prescription alternatives to OSPs include oral solutions such as Colyte and TryLyte, neither of which contains sodium phosphate.
If you, a loved one or a friend have used a bowel cleansing prep containing sodium phosphate, such as Visicol or OsmoPrep and have suffered kidney damage, you may be entitled to money damages. Contact one of our dangerous products attorneys for a free legal consultation.