Fleet Phospho Soda Side Effects Were Ignored
The Fleet Phospho-soda attorneys at Saiontz & Kirk, P.A. are investigating potential lawsuits for individuals who have suffered severe kidney damage after a colonoscopy prep where Fleet Phospho-soda was used. While most consumers only became aware of the potential for Fleet Phospho-soda kidney problems when the product was recalled in December 2008, the manufacturer has been aware of the potential side effects for years.
>>INFORMATION: Fleet Phospho-soda Side Effects Lawsuit
C.B. Fleet Company’s oral sodium phosphate solution Fleet Phosphosoda has been used as a laxative since 1893. However, problems that led to the recall started when they began marketing double doses of the laxative for use as a bowel cleanser before colonoscopy examinations in 1992. Although the product was not established as safe and effective for use at such high doses required to cleanse the bowels, C.B. Fleet downplayed the risk and largely ignored the potential Fleet Phospho-soda side effects.
Fleet unsuccessfully attempted several times to convince the FDA to repeal its dose limit of 45mL in a 24-hour period, which is about half of what they promoted for a colonoscopy prep. Despite the FDA rejecting its request, suggesting that it was not established as safe at higher concentrations, the company continued pushing the off-label use, going as far as marketing the laxative under names like Fleet Phospho-soda Accu-Prep and Fleet Phospho-soda EZ Prep.
By the late 1990s, Fleet was well aware of the side effects of Fleet Phospho-soda when used at double doses, and failed to properly warn consumers or the medical community.
In 2001, the FDA released a science background paper indicating that Fleet Phospho-soda was associated with kidney failure and death when taken at higher doses, stressing that doctors need to be alerted to the health risks since the Fleet Phospho-soda was routinely used as a colonscopy prep. However, a 2002 “Dear Doctor” letter sent by Fleet actively downplayed the risk and did not indicate that cases of renal failure occurred in patients with and without other risk factors.
In March 2003, Dr. Glen Markowitz, a renal pathologist at Columbia University, alerted Fleet to his personal findings of kidney damage when he performed kidney biopsies and first diagnosed the condition as nephrocalcinosis, now known as acute phosphate nepropathy. Fleet tried to discredit the findings instead of issuing appropriate warnings.
The first known Fleet Phospho-soda lawsuit was filed in late 2004, and the company has reportedly negotiated settlements or other resolutions for over 120 cases since that time. However, now that the Fleet Phospho-soda kidney side effects are known, they face a hundreds of new cases throughout the United States.
A Fleet Phopho-soda recall was issued in December 2008, the same day the FDA indicated that the warnings for the over-the-counter laxative were not adequately warning doctors and patients about the potential acute phosphate nephropathy side effects from Fleet Phospho-soda when used as a bowel cleanser for colonoscopy prep.
FLEET PHOSPHO-SODA ATTORNEYS
When used at high doses for colonoscopy prep, Fleet Phospho-soda side affects could increase the risk of kidney damage, kidney failure, the need for kidney transplant or even death. As a result of C.B. Fleet’s failure to adequately warn about the problems, users were not given the opportunity to make an informed decision about whether to use the products or other safer alternatives that were available.
If you, a friend or family member have been diagnosed with acute phosphate nephropathy or suffered other Fleet Phospho-sida kidney problems, financial compensation may be available. To determine whether you may qualify for a claim, request a free consultation and case evaluation.
1 Comment • Add Your Comments
Juanita says:
Each time my doctor put me in the hospital for colon problems, app. 9 times in the last 5 years,I was told to prep w/ Fleet PHospho soda and each time I got worse, was put on another bad drug, Zelnorm and final the out-come was complete colon removed it collapped and stoped working all together, I had no feeling at all.
Posted on September 9, 2009 at 1:59 pm