In response to the Food and Drug Administration’s stern safety warning last December about the risk of a rare form of kidney failure associated with two oral sodium phosphate medicines prescribed to cleanse the colon prior to a colonoscopy, C.B. Fleet Company Inc. announced a voluntary recall of its over-the-counter Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System.
The FDA’s warning specifically named Salix Pharmaceuticals’ prescription drugs Visicol and OsmoPrep, citing more than 20 reports of the rare kidney failure following use of the products. As a result, Salix Pharmaceuticals added a new boxed warning label to those medications warning healthcare providers to use caution when prescribing the drugs to older patients, those who suffer from dehydration and kidney disease, or take medications that affect the kidneys.
The FDA also raised concerns of similar risks with improper use of over-the-counter bowel cleaners, such as those sold by C.B. Fleet. While many of these over-the-counter products are labeled to treat constipation, regulators say they are often used at higher doses to cleanse the colon.
C.B. Fleet’s decision to recall its Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System was made to address the FDA’s determination that oral sodium phosphate solutions should only be available by prescription and that consumers should not be using the products for bowel cleansing.
Nonprescription products cannot receive boxed warnings; however, the FDA plans to require stricter labeling on many of the OTC phosphate drugs to warn of the risk of kidney failure.
Source: C.B. Fleet