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SILVER SPRING, Md. — The Food and Drug Administration will propose an amendment to the over-the-counter laxative monograph that sodium phosphate salts are not generally recognized as safe for bowel cleansing.
A request for public comments will be published in Friday’s Federal Register.
“[The] FDA is issuing this proposed rule after a careful review of new data and information on the serious side effects that have been associated with the customary dose of OTC sodium phosphates solution … for bowel cleansing prior to colonoscopy,” the agency stated.
The FDA initially raised safety concerns in 2008, after which Fleet Labs, which fielded an OTC product containing a sodium phosphate solution, voluntarily recalled that product (Fleet Phospho-soda).
Oral sodium phosphate products often are recommended by physicians for bowel cleansing prior to a colonoscopy or other medical procedure.
The safety issues raised by the prescription and professional use of OSP for bowel cleansing has led the FDA to reconsider the appropriateness of bowel cleansing as an OTC indication. However, the agency planned to address the status of bowel cleansing as an OTC indication in a future Federal Register publication.