Oral Sodium Phosphate (Over-the-Counter)

21 July 2009

Products Affected - Description

Fleets Phospho-Soda, Fleet - discontinued
GNP saline oral laxative, Unico Holdings - discontinued
Oral saline laxative, Major - discontinued

Reason for the Shortage

Over-the-counter oral sodium phosphate products were voluntarily discontinued in late 2008.^1-3 In December 2008, the FDA recommended these products be available by prescription only because of safety concerns. In addition, FDA required all manufacturers of oral sodium phosphate products to institute risk evaluation and mitigation strategies.⁴

Estimated Resupply Dates

Over-the-counter oral sodium phosphate products are discontinued.^1-3

Alternative Agents & Management

Salix Pharmaceuticals has available for prescription Visicol tablets in 40-count bottles (NDC 65649-0601-04) and 100-count bottles (NDC 65649-0601-49) and OsmoPrep tablets in 100-count bottles (NDC 65649-0701-41).⁵ Monitor patients for acute phosphate nephropathy when prescribing these agents for bowel cleansing.⁴

Related Shortages

1. Fleet, (personal communication). January 9, 2009.
2. Unico Holdings, (personal communication). January 9, 2009.
3. Major, (personal communication). January 9, 2009.
4. U.S. Food and Drug Administration. Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription). Accessed on July 21, 2009.
5. Salix Pharmaceuticals, (personal communication). January 9, 2009.
   

Updated

Created July 21, 2009, by M. Christina Beckwith, Pharm.D., Drug Information Specialist. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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