FDAnews Drug Daily Bulletin

ALERT ISSUED FOR OSP PRODUCTS

May 17, 2006
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The FDA has notified health professions of a serious adverse event associated with oral sodium phosphates (OSP) used for bowel cleansing.

The alert cites 22 cases of acute phosphate nephropathy, a rare type of acute renal failure, in patients taking both OSP solution, such as Fleet Phospho-soda or Fleet ACCU-PREP, and tablets, such as Visicol). The FDA advises that the product should not be used in patients with such conditions as kidney disease, advanced age or decreased intravascular volume. Patients taking medications affecting renal functions should also be considered at risk.

No cases of acute phosphate nephrology have been reported in use of OsmpPrep, a recently approved OSP tablet. The full text of the alert can be viewed here (http://www.fda.gov/cder/drug/infopage/OSP_solution/default.htm).