FDA says some OTC bowel cleansing systems should be RX-only

LYNCHBURG, Va. Following the issuance of a Food and Drug Administration Safety Alert last week stating that oral sodium phosphates bowel cleansing solutions should be available by prescription only because of a potential risk of kidney injury, C.B. Fleet Company immediately announced a voluntary recall of their over the-counter products Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System.

The recall decision was made to address FDA’s determination that oral sodium phosphate solutions used for bowel preparation prior to medical procedures such as colonoscopy should only be available by prescription, and consumers should not be using over-the-counter products for bowel cleansing.

The FDA last week added a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury).

The FDA has also directed the manufacturer of these products to develop a risk evaluation and mitigation strategy, distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of these products and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with the use of these products.

The agency stated that it is equally concerned about the risks associated with the use of OSP products that are available OTC when used at higher doses for bowel cleansing. The available data do not show a risk of acute kidney injury when these OTC products are used at the lower doses for laxative use, the FDA stated. However, when used for bowel cleansing, these products have the same risks as prescription OSP products.

“Though rare, these are serious adverse events associated with the use of oral sodium phosphates—both prescription and over-the-counter products,” stated Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “In some cases, these serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk for developing kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products or they did not drink sufficient fluids after ingesting OSP products.”