Fleet Enema Recall OsmoPrep Side Effects | Phosphate Soda Recall

by admin on April 1st, 2010

In 2008, CB Fleet Company, Inc. announced a Fleet enema recall of their over-the-counter drug, Fleet Phospho-soda, after several people suffered from kidney failure. Fleet is a colonoscopy preparation drug that prompted warnings from the FDA stating that Fleet should not be available as a laxative in preparation for a colonoscopy because of Fleet kidney failure . The FDA also issued warnings of Visicol and OsmoPrep side effects involving kidney injury, although there was no recall. Osmoprep lawsuit claims are currently being filed around the country on behalf of patients and families.

A colonoscopy is a procedure used to inspect the large intestine of the body for polyps and abnormalities. To prepare for a colonoscopy, patients are instructed to use a bowl cleansing solution. Fleet Phospho-Soda is such a solution, which is an oral sodium phosphate (OSP) that used to be available over the counter. When used properly, it flushed the colon of feces, making it easier for doctors to see inside. However, after using this product—within days or weeks following the bowel cleansing—some people suffered from a severe injury to their kidneys.

The FDA warnings and phosphate soda recall about Fleet kidney failure were announced after several people suffered from kidney problems called acute phosphate nephropathy (renal failure). In cases of acute phosphate nephropathy, calcium phosphate crystals deposit in the renal tubules causing kidney failure, which can be permanent. Because of the risk of Fleet kidney damage, the FDA decided that the Fleet laxative products should not be used.

Kidneys act as a filter for the body. They screen out toxins in the blood and carry them out through the urine. In addition, kidneys also help to produce hormones that regulate the body’s blood pressure, and produce a hormone that helps make red blood cells and balances the body’s fluid levels. When kidneys are not functioning properly, the damage can be severe, including tiredness, shortness of breath, decreased urine output, leg swelling, confusion, seizures, and comas. Some kidney problems can be reversed, but at advanced stages, kidneys may be permanently damaged and may not return to their full functionality.

Some people have argued that Fleet advertised their laxative products for use at very high dosage rates without adequate warnings about the risk of Fleet kidney failure for years prior to the recall. People with known kidney disorders were especially vulnerable to kidney failure, and may have avoided the life-threatening acute phosphate nephropathy if there had been stronger warnings.

It is unknown exactly how many people have suffered from Fleet kidney failure. If you have taken Fleet Phospho-Soda or OsmoPrep in preparation for a colonoscopy or surgery, and have developed kidney problems, please contact us and one of our attorneys will help explain your legal options. There is never any cost to speak to one of our phospho soda lawsuit lawyers.