The FDA has received reports of acute phosphate nephropathy associated with the use of oral sodium phosphate (OSP) products for bowel cleansing prior to colonoscopy or other procedures. These products include prescription medications Visicol and OsmoPrep (both manufactured by Salix) and over-the-counter OSP products available as laxatives (e.g. Fleet Phospho-soda).
The FDA is requiring Salix to add a Boxed Warning to both the Visicol and OsmoPrep labeling. Additionally, the manufacturer is required to develop and implement a risk evaluation and mitigation strategy (REMS), which includes a Medication Guide, to ensure that the benefit outweighs the risks. They will also have to conduct a postmarketing clinical trial to further evaluate the risk of acute kidney injury with these products. The FDA is also recommending that over-the-counter laxative OSP products should not be used for bowel cleansing.
Oral sodium phosphate products are indicated for bowel cleansing prior to colonoscopy or other procedures.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094900.htm.