NEWS - Oral sodium phosphate products linked to acute phosphate nephropathy

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Medscape Alerts

Laurie Barclay, MD

Oral Sodium Phosphate Products Linked to Acute Phosphate Nephropathy

December 12, 2008 — Acute phosphate nephropathy has been reported in

association with the use of oral sodium phosphate products (OSPs), the

US Food and Drug Administration (FDA) announced yesterday.

The FDA has therefore required the manufacturer of prescription OSPs

Visicol (Salix Pharmaceuticals) and OsmoPrep (Salix Pharmaceuticals)

to add a boxed warning to the labeling for these products, according

to an alert sent yesterday from MedWatch, the FDA's safety information

and adverse event reporting program.

" Though rare, these are serious adverse events associated with the use

of oral sodium phosphates — both prescription and over-the-counter

products, " Janet Woodcock, MD, director of FDA's Center for Drug

Evaluation and Research, said in a news release.

" In some cases, these serious adverse events occurred in patients with

no pre-existing health factors that would have put them at risk for

developing kidney injury, " Dr. Woodcock said. " We cannot rule out,

however, that some of these patients were dehydrated prior to

ingestion of OSP products or they did not drink sufficient fluids

after ingesting OSP products. "

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Read the full article here:

http://www.medscape.com/viewarticle/585246

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