Black-Box Warning Added to two Prescription Drugs by FDA
The U.S. Food and Drug Administration recently announced that it now requires a black-box warning to be put on the labeling for two prescription drug products used prior to a colonoscopy. It has been reported to the FDA that the oral sodium phosphate products, Visicol and OsmoPrep have caused kidney injury. “The FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep,” Dr. Joyce Korvick, deputy director of FDA's Division of Gastroenterology Products at the Center for Drug Evaluation and Research said.
“Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use.” The FDA is also concerned about similar non-prescription treatments, such as Fleet Phospho-soda made by C.B. Fleet Co. and stated they will get new warnings as well.
