Following Fleet Phospho-soda Recall Researchers Look at Alternatives

Researchers are examining a number of colonoscopy prep alternatives following reports of serious and potentially life-threatening kidney problems that resulted in a Fleet Phosphosoda recall almost a year ago.

At the 74th Annual Scientific Meeting of the American College of Gastroenterology, several studies and papers were presented delving into bowel preparation prior to colonoscopy examinations. In addition to a study that emphasized the importance of bowel prep for successful colonoscopy exams, there were also papers presented on the effectiveness of a variety of products which may replace Fleet Phospho-soda, which was a widely used over-the-counter choice by many doctors for cleansing the bowels before the examination.

Bowel preparation is the process of clearing out the bowels to ensure the accuracy of colonoscopy exams, which are used to examine the colon for polyps that could be indicative of colon cancer. Colonoscopy examinations are also frequently used to diagnose inflammatory bowel disease.

One pilot study presented at the conference found that polyethylene glycol (PEG) with absorbic acid resulted in excellent or good bowel prep 92% of the time in 90 patients that were examined. The study found that 62% of colonoscopy patients said that it was easy to use. PEG is used in brand name laxatives such as MoviPrep, MiraLAX, and NuLytely, among others.

The same study also looked at the use of magnesium citrate, a saline laxative sold generically and under the brand names Citromag and Citroma. The study found that magnesium citrate resulted in excellent or good bowel prep 86% of the time, and 82% of patients found it easy to use. Researchers from Mt. Sinai School of Medicine said it appeared that both magnesium citrate and PEG could turn out to be good alternatives to replace Fleet Phospho-soda.

Another study presented at the conference found that oral sulfate solutions, sold under the brand name of Suprep, faired better in both bowel prep results and in patients’ ability to tolerate and properly complete the preparation. All of the 130 patients studied who used a split dose of oral sulfate solution, taking a dose at night and a dose in the morning before an examination, were able to complete the procedure, compared to 91% of those using NuLytely, which is a PEG and electrolyte solution blend. Researchers said colonoscopy prep using NuLytely required patients to drink four liters of the solution, which many found difficult to do.

Fleet Phospho-soda was an oral sodium phosphate solution that was available over-the-counter as a laxative. However, over the past 15 years it was widely promoted and used at double doses to clear out the bowels before a colonoscopy.

A recall for Fleet Phospho-soda was issued in December 2008, after the FDA issued a warning that the laxative should not be used as a bowel cleanser due to an increased risk of kidney damage side effects when taken at high doses.

A number of Fleet Phosphosoda lawsuits have been filed against the manufacturer, alleging that they failed to research the product before encouraging doctors to have patients purchase two bottles of the laxative as an alternative to prescription colonoscopy prep products. The complaints also allege that the manufacturer failed to warn users and the medical community about the potential Fleet Phospho-soda kidney side effects.

While the first Phospho-soda case was filed against C.B. Fleet Co. in 2004, and more than 120 cases were reportedly settled prior to the recall, the number of kidney failure lawsuits has grown since the product was pulled from the market. In June 2009, all federal Fleet Phosphosoda lawsuit claims were consolidated into an MDL, or multidistrict litigation, for pretrial proceedings to avoid inconsistent rulings by different judges in different courts, eliminate duplicate discovery for issues that are common to all cases and to serve the convenience of the parties, the witnesses and the court.