New Warnings for oral sodium phosphates

May 5, 2006 - The FDA notified healthcare professionals and consumers of reports of acute phosphate nephropathy, a type of acute renal failure, that is a rare, but serious adverse event associated with the use of oral sodium phosphates (OSP) for bowel cleansing. Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution (such as Fleet Phospho-soda or Fleet ACCU-PREP) and one patient who used OSP tablets (Visicol). Individuals at increased risk of acute phosphate nephropathy include: those of advanced age, those with kidney disease or decreased intravascular volume, and those using medicines that affect renal perfusion or function [diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly nonsteroidal anti-inflammatory drugs (NSAIDs)]. The most common risks and side effects of OSP therapy are Dehydration, abdominal pain or bloating, nausea, vomiting, headache and dizziness. Patients should alter their physician if they have any unusual symptoms or if they are having difficulty drinking liquids during their bowel cleansing.

More information can be found on the FDA website. www.FDA.gov, or http://www.fda.gov/cder/drug/InfoSheets/patient/OSP_solutionPIS.htm.

As always, pharmacies and members can contact the RxAmerica Customer Service Desk at 1-800-770-8014 if they have any questions about this new drug information.