Fleet recalls drugs over kidney risk
C.B. Fleet Co., a closely held maker of laxative products, said Thursday that it was voluntarily withdrawing its oral, over-the-counter bowel cleansing solutions after U.S. health regulators warned that such drugs may harm the kidneys.
C.B. Fleet said it would recall its Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System used to clear the bowels before a colonoscopy. The decision was made because the Food and Drug Administration said Thursday that this class of drugs should be available only by prescription, Fleet said.
The FDA said people should refrain from using the drugs, which have been linked to acute phosphate nephropathy, an injury that can lead to permanent kidney damage.
The agency described dangers associated with the preparations in 2006 and since then has received additional reports of injury. Thursday’s action followed a citizen petition seeking stronger warnings.
There isn’t evidence that the nonprescription products pose a kidney risk when used as laxatives at lower doses, according to the FDA.