On December 11, 2008, C.B. Fleet Co., a closely held maker of laxative products, said that it was voluntarily withdrawing its oral, over-the-counter bowel cleansing solutions after the FDA warned that oral sodium phosphates may cause kidney damage, including acute phosphate nephropathy. 

The products that C.B. Fleet withdrew from the market include its Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System.  Both over-the-counter Fleet products are used to clear the bowels before a colonoscopy.  Bloomberg News reported that the company made the decision because the FDA said that this class of drugs should be available only by prescription.

Fleet Phospho-Soda’s generic name is sodium biphosphonate and sodium

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phosphate (pronounced “SOE dee um bye FOS foe nate” and “SOE dee um FOS fate”).  Sodium biphosphonate and sodium phosphate are forms of phosphorus, which is a naturally occurring substance that is important in every cell in the body.  Sodium biphosphonate and sodium phosphate is used to treat constipation and to clean the bowel before surgery, x-rays, endoscopy, or other intestinal procedures. Sodium biphosphonate and sodium phosphate enemas are also used for general care after surgery and to help relieve impacted bowels.

The FDA’s requirement that a boxed warning appear on the prescription version of oral sodium phosphates (including Visicol and OsmoPrep, manufactured by Salix Pharmaceuticals) and the Fleet voluntary withdraw of the Fleet Phospho-soda products, followed a citizen petition seeking stronger warnings for oral sodium phosphates.  According to the FDA, there isn’t evidence that the nonprescription products, such as the Phospho-sodas, pose a kidney risk when used as laxatives at lower doses.

The recall covers all codes of the following Fleet products:

  • Fleet Phospho-Soda Oral Saline Laxative, Unflavored, 1.5oz
  • Fleet Phospho-Soda Oral Saline Laxative, Ginger-Lemon, 1.5oz
  • Fleet Phospho-Soda EZ-Prep Bowel Cleansing System

According to pharmacies such as Wegmans, all of these products may be returned to the customer service desk for a full refund.  For more information about the recall, consumers may call Fleet Laboratories at 1-800-999-9711.

Contact a Fleet Phospho-soda Kidney Injury Lawyer about an Acute Phosphate Nephropathy Lawsuit Today

If you or a loved one used over-the-counter Fleet Phospho-soda or a prescription OSP and suffered acute phosphate nephropathy or other Fleet Phospho Soda side effects, contact our experienced Fleet Phospho Soda lawyers and attorneys today for a confidential free case evaluation to find out if you have a Fleet Phospho-Soda lawsuit.

Published November 17, 2011 by