This is an update to our May, 2006 recall alert regarding bowel cleansing products associated with kidney failure. In December of 2008, CB Fleet Company, Inc. recalled their over-the-counter colonoscopy preparation drug Fleet Phospho-soda after warnings from the FDA stating that Fleet should not be available as an OTC laxative prep for colonoscopy.
The FDA warnings came after several patients developed kidney problems (renal failure) called acute phosphate nephropathy. In acute phosphate nephropathy, calcium-phosphate crystals deposit in the renal tubules causing permanent kidney damage. This can result in the need for life-long dialysis.
Due to the risk of acute phosphate nephropathy, the FDA has determined that over-the-counter laxative oral sodium phosphate (OSP) products such as Fleet Phospho-Soda should not be used for bowel cleansing.
Immediately after the FDA warning, C.B. Fleet Company announced a recall of their OTC products Fleet Phospho-soda® and EZ-Prep Bowel Cleansing System®. Fleet Phosphasoda contains oral sodium phosphate, which was approved by the FDA for OTC use as a laxative. However, Fleet promoted their laxative for use at very high doses as a bowel prep without adequate warnings about the potential risk for kidney damage for years prior to the recall. Some patients, especially those with known kidney disorders, may have been able to avoid potentially life-threatening acute phosphate nephropathy if proper warnings had been provided.
If you have taken OTC Phosphosoda in preparation for a colonoscopy, radiological procedure or surgery, and have developed kidney problems, contact your doctor immediately to discuss a possible link. You may also have legal rights to compensation for your permanent injury.