In December 2008, CB Fleet Company, Inc. recalled their colonoscopy prep Fleet Phosphosoda after the FDA indicated it should not be available over-the-counter. For years Fleet promoted their laxative for use at high doses as a bowel prep without adequate warnings about the potential risk for kidney damage. If proper warnings had been provided, many people may have avoided potentially life-threatening health problems by choosing one of the available Fleet Phospho Soda alternatives.
>INFORMATION: Fleet Phospho-soda Lawsuits
The Fleet recall was issued for Fleet Phospho-soda and Fleet Phospho-soda EZ Prep due to a potential risk that the high doses necessary for bowel cleansing may lead to acute phosphate nephropathy, a severe form of kidney damage that could cause renal failure, dialysis treatment or death.
Fleet Phosphasoda contains oral sodium phosphate, which was only approved for over-the-counter use as a laxative. However, about 15 years ago Fleet began marketing the use of double doses to cleanse the bowels before a colonoscopy or other surgical procedure.
There are currently two other oral sodium phosphate products that are approved by the FDA with a prescription, Visicol tablets and OsmoPrep tablets. The FDA has required the manufacturers to add a new “black box” warning about the potential risk of acute phosphate nephropathy and patients will now be provided with a Medication Guide to help make sure they are aware of the potential side effects.
CB Fleet Company has indicated that they plan to seek approval to reintroduce Phospho soda as a prescription product with the same new warnings that have been applied to Visicol and OsmoPrep.
However, there are several Fleet Phospho-soda alternatives that are already available that do not contain oral sodium phosphate and do not appear to carry the same risk of kidney damage. These include PEG solutions such as Golytely, Halflytely and Moviprep.
FLEET RECALL LAWSUITS
The Fleet Phosphosoda lawyers at Saiontz & Kirk, P.A. are investigating potential lawsuits on behalf of individuals who have been diagnosed with acute phosphate nephropathy or kidney damage after using a double dose of the oral sodium phosphate solution to cleanse their bowels before surgery or a colonoscopy.
CB Fleet has been aware of the potential risk of kidney damage for a number of years, yet they continued to market use of the product at high doses and failed to warn about the risk. If individuals had been warned about the risk of acute phosphate nephropathy, many may have chosen alternatives to Fleet Phospho-soda and avoided these problems.
To review a potential case with an attorney and find out if compensation may be available, request a free consultation and case evaluation.