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Health Agencies Update
January 28, 2009

Oral Sodium Phosphate Risks

JAMA. 2009;301(4):370. doi:10.1001/jama.2008.988

Certain prescription and over-the-counter drugs used for bowel cleansing may cause acute kidney injury, the US Food and Drug Administration (FDA) warned.

The agency is adding a boxed warning to 2 prescription oral sodium phosphate products, Visicol and OsmoPrep, to caution consumers about the risk of developing acute phosphate nephropathy after using these products, which are routinely prescribed to cleanse the bowel prior to colonoscopy. Individuals who appear to have an increased risk include persons who are older than age 55 years; who are dehydrated or have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function. The manufacturers of oral sodium phosphate also are being asked to develop a risk evaluation and mitigation strategy, provide patients with a patient medication guide describing the risk, and conduct a postmarketing clinical trial.

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