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Oral Sodium Phosphate (Over-the-Counter) Solution

Last Updated: June 12, 2013
Status: Discontinued

Products Affected - Description

Fleets Phospho-Soda, Fleet - discontinued
GNP saline oral laxative, Unico Holdings - discontinued
Phosphate laxative (Major) – discontinued  

Reason for the Shortage

  • Over-the-counter oral sodium phosphate products were voluntarily discontinued in late 2008.1-3 These products are safe when used as laxatives at low doses, but higher doses used for bowel cleansing have been associated with acute kidney injury. FDA recommends these products not be used for bowel cleansing without a prescription from a healthcare professional. In addition, FDA required all manufacturers of prescription oral sodium phosphate products to add a boxed warning to the product labeling and institute risk evaluation and mitigation strategies.4
  • Major Pharmaceuticals discontinued their oral saline laxative in early-April 2013 due to supplier issues.3
  • Salix Pharmaceuticals discontinued Visicol tablets in January 2012.
  • Oral saline laxative is an over-the-counter product and may be available through various stores or wholesalers as a store-brand product.
 

Available Products

  • No presentations are available.

Estimated Resupply Dates

  • The above products have all been discontinued.1-3

Alternative Agents & Management

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

Related Shortages

References

  1. Fleet, (personal communication). January 9, 2009.
  2. Unico Holdings, (personal communication). January 9, 2009.
  3. Major, (personal communication). January 9, 2009; March 22, 2011; June 12, 2013.
  4. Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription).  U.S. Food and Drug Administration. Accessed on June 12, 2013.
  5. Salix Pharmaceuticals, (personal communication). January 9, 2009; March 22, 2011; June 12, 2013.

Updated

Updated June 12, 2013, by Megan Dryer, Drug Information Specialist. Created July 21, 2009, by M. Christina Beckwith, PharmD Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.

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