Fleet Recall 2009

by admin on April 15th, 2010

A Fleet enema recall was issued in December 2008 after FDA warnings about possible severe kidney damage. The products that were recalled were Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System. OsmoPrep kidney damage also triggered a black box warning for another common bowel cleansing product around the same time. The over-the-counter Fleet products which were recalled by the manufacturer, CB Fleet Company, Inc. Please contact us for the latest Fleet recall 2009 and 2010 litigation updates.

The products affected by the Fleet enema recall were bowel cleaning products used to prepare a patient for a colonoscopy. As many people know, prior to a colonoscopy, patients must clear their bowels so that the doctor can see the colon with a camera. The Fleet products accomplished this, but, in some cases, also caused permanent Fleet phospho-soda kidney damage.

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. 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).

Because of the risk of phospho soda kidney damage, the FDA decided that the Fleet laxative products should not be used as over-the-counter products.

Doctors recommend that people age 50 and over undergo a colonoscopy every 10 years. A colonoscopy screens for polyps that can become cancerous. A 10-year screening interval is for people at low risk of colon cancer; people at high risk, and people with a prior colonoscopy that caught a polyp, may need to undergo a colonoscopy more often.

In addition to using a bowel cleaning system prior to a colonoscopy, your doctor will likely have you under some diet and fluid restrictions in the days leading up to the procedure. You may be asked to discontinue eating solid foods. You should check with your doctor before the colonoscopy regarding any restrictions and conditions he or she thinks are appropriate.

If you or a loved one suffered from a kidney injury and have a question regarding the Fleet recall or filing an OsmoPrep lawsuit, please contact us for a free no-obligation consultation regarding your legal options.