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PHOS-NaK FDA Alerts

The FDA Alert(s) below may be specifically about PHOS-NaK or relate to a group or class of drugs which include PHOS-NaK (potassium phosphate/sodium phosphate).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for potassium phosphate/sodium phosphate

Oral Sodium Phosphate (OSP) Products for Bowel Cleansing

May 5, 2006

Audience: Consumers, pharmacists and other healthcare professionals

[Posted 05/05/2006] 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)]. Recommendations were offered for providers and patients when choosing and using a bowel cleanser.

[May 05, 2006 - Drug Information Page - FDA]

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