Fleet Bowel Prep Recall

by admin on July 1st, 2010

The Fleet bowel prep recall for over-the-counter sales was announced in December 2008. The products that were recalled were the over-the-counter drugs, Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System. CB Fleet Company, Inc. issued this Fleet Recall after several people suffered from kidney failure.

Fleet was advertised as a colonoscopy preparation drug. To prepare for a colonoscopy, patients are instructed to use a bowl cleansing solution. The Fleet products were such a solution, which was 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, some people suffered from a severe injury to their kidneys. These serious problems prompted the Fleet Recall.

The Fleet phospho soda recall came after the FDA warned that several patients had 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 kidney failure, the FDA decided that the Fleet laxative products should not be used. The Fleet Recall was then issued, and the Fleet products were pulled from the shelves.

It has been 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 Fleet Recall. People with known kidney disorders were especially vulnerable to kidney failure, and could have avoided the life-threatening acute phosphate nephropathy if there had been proper warnings. The FDA warned that the following people were at an increased risk of developing acute phosphate nephropathy:

• People who are 55 years or older,
• People who are dehydrated,
• People who have a history of kidney problems,
• People who have delayed bowel emptying,
• People who have active colitis, or
• People who take certain medications that affect kidney function, such as diuretic (fluid) pills, angiotensin converting enzyme (ACE) inhibitors (medications that lower blood pressure), angiotensin receptor blockers (ARBs, used to treat high blood pressure, heart or kidney failure), and possibly nonsteroidal anti-inflammatory drugs (NSAIDS, like ibuprofen or other arthritis medications).

It is unknown exactly how many people have suffered from Fleet kidney failure. If you have taken Fleet Phospho-Soda or Fleet Phospho-soda EZ-Prep Bowel Cleansing System in preparation for a colonoscopy or surgery, and have developed kidney problems, contact your doctor immediately. You also have legal rights for a permanent injury of kidney failure. However, the law limits the time you have to bring a claim, so you should contact a Fleet phospho soda lawsuit attorney as soon as possible.