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U.S. Department of Health and Human Services

Safety

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Visicol and OsmoPrep

  • OsmoPrep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) tablets
  • Visicol (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009

 

Summary View

 

REMS

  • Since May 2006, FDA has continued to receive reports of acute kidney injury with both prescription and over-the-counter oral sodium phosphate products. Twenty unique cases of acute kidney injury associated with the use of OsmoPrep were reported which included 3 cases of biopsy proven acute phosphate nephropathy. In addition, observational retrospective cohort studies were published which reported an increased risk of acute kidney injury in patients undergoing bowel cleansing using oral sodium phosphate products, as defined by changes in serum creatinine. We considered this information to be “new safety information” as defined in FDAAA.
  • The REMS consists of a Medication Guide, a communication plan, and a timetable for submission of assessments of the REMS.