|TO:||DDS Regional Directors, STS Director, CTH Coordinators, Private Providers|
|FROM:||Daniel A. Micari, Director, Quality Management Services|
|DATE:||December 17, 2008|
|RE:||MEDICAL ADVISORY: Oral Sodium Phosphate (OSP) Products for Bowel Cleansing: reports of acute phosphate nephropathy, Boxed Warning to be added to labeling|
This MEDICAL Advisory is to advise that the FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.
Read the MedWatch 2008 safety summary, including a link to the FDA Drug Information Page, at:http://www.fda.gov/medwatch/safety/2008/safety08.htm#OSP
Please ensure those responsible for medicine acquisition and administration are aware of this medical advisory. Also review your medicine stores to determine whether or not the identified products are present. If the identified products are present, address appropriately.