>>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.

>>INFORMATION: Fleet Phospho Soda Problems

According to a report in The News and Advance of Lynchburg, Virginia, despite the Fleet Phospho-soda issues, C.B. Fleet officials maintain that their product is safe when used as directed, and the company is seeking FDA approval to sell them again in a limited manner that they believe will ensure that the products are used in a way that will not pose an increased risk of kidney injury.

A recall for Fleet Phospho Soda was issued in December 2008 after the FDA indicated that double doses being used for colonoscopy prep or other surgical procedures could lead to a form of kidney damage known as acute phosphate nephropathy, which can cause renal failure, dialysis treatment or death.

C.B. Fleet currently faces a number of Fleet Phospho-soda suits alleging that they promoted use of high doses of the laxatives as an alternative to prescription colonoscopy prep products without researching the safety of such use or adequately warning about the risk of kidney injury.

Fleet Phospho-Soda is an oral sodium phosphate-based medication which was only approved for over-the-counter use as a laxative, not to cleanse the bowels before a colonoscopy. Other oral sodium phosphate solutions are available as a prescription, such as Visicol and OsmoPrep, which are approved as bowel cleansers. However, those products contain “black box” warnings, which are the strongest warnings that can be placed on a prescription medication, about the risk of acute phosphate nephropathy and kidney injury.

Fleet officials say they are in discussion with the FDA about possibly making the recalled products available by prescription and with more detailed instructions and warning labels. However, we have raised questions before about why such a product would be approved, since there are already several safer alternatives available that do not contain oral sodium phosphate and do not appear to carry the same risk of kidney damage.

FLEET PHOSPHO SODA ATTORNEYS

The Fleet Phospho-soda attorneys at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing claims against C.B. Fleet over problems allegedly caused by their promotion of double doses of the laxative. Potential Fleet Phospho-soda lawsuits are being reviewed for individuals diagnosed with:

• Acute Phosphate Nephropathy
• Kidney Failure
• Chronic Kidney Disease
• End Stage Renal Failure
• Other Kidney Injury
• Death

If you, a friend or family member have experienced problems, request a free consultation and claim evaluation.

>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.

>>LEARN MORE: Fleet Phospho-soda Lawsuits

In December 2008, the FDA issued a warning about the use of oral sodium phosphate products like Fleet Phospho-soda as bowel cleansers.

The makers of two prescription oral sodium phosphate products, Visicol and OsmoPrep, were required to add a new black box warning about the risk of kidney damage, develop a risk mitigation strategy and provide medication guides to ensure that individuals are aware of the risks and alternatives before using these products.

Although Fleet Phospho-soda was an oral sodium phosphate solution which was available over the counter as a laxative, C.B. Fleet Co., Inc. heavily marketed and promoted their product for use at high doses for bowel prep. Use of the product at double the approved doses was never established as safe and the FDA would not have approved the product for over-the-counter use at those doses.

When the FDA issued their December alert, they indicated that over-the-counter laxatives like Fleet Phospho-soda should not be used for bowel prep and should only be available as a prescription. That same day, C.B. Fleet issued a Fleet Phospho-soda reccall.

Although Fleet was aware of the risk of kidney damage for years, they marketed the product as a bowel cleanser for years without adequate warnings for consumers or the medical community. As a result of their decision to place profits before consumer safety, individuals who have been diagnosed with acute phosphate nephropathy or other kidney damage from Fleet Phospho-soda may be entitle to financial compensation.

The acute phosphate nephropathy lawyers at Saiontz & Kirk, P.A. are providing free consultations and claim evaluations for individuals throughout the United States and there are no fees or expenses unless a recovery is obtained.

Potential cases are being pursued for individuals who have been diagnosed with :

• Kidney Damage
• Kidney Failure
• Kidney Disease
• Acute Phosphate Nephropathy (also known as Acute Nephrocalcinosis)

The damage done to the kidneys is permanent and may lead to the need for dialysis treatment, a kidney transplant or even death.

If you, a friend or family member have suffered from Fleet Phospho-soda kidney damage, request a free consultation and claim evaluation.