Monday, October 5, 2009

Is your laxative hurting you?

Fleet Phospho-soda is an over-the-counter laxative product that has been manufactured and marketed by CB Fleet Company for over a hundred years. These products have been approved by the FDA for use as laxative in a lower dose and appear to be safe. However, problems Began to occur in the 1990's, when CB Fleet Company Began teaming up with pharmaceutical companies to mass market the product in double doses to doctors offices and gastroenterologist's clinics across the country as a preparatory solution for a colonoscopy procedure, something that the FDA has never given approval for. Fleet Phospho-soda works by pulling fluid from every part of the body and transferring it into the colon thus creating a laxative effect. In higher doses, calcium-phosphate crystals form in parts of the kidneys called the renal tubules causing permanent kidney damage or even complete kidney failure. This results in the patient having to undergo kidney dialysis for the remainder of their life unless a compatible kidney donor is found and the patient survives a kidney transplant.

The first sign of concern came from a team of doctors in New York in 2003. At that time they reported a definite link between kidney damage and Fleet's products. Two years later in 2005, the FDA issued a mild warning that there is a possibility of kidney damage Resulting from the use of sodium phosphate tablets or solution as a bowel cleanser. But the company continued to market products and it's even more aggressively in August of 2007 when it agreed to pay Santarus, Inc.. to help push the medication to doctors to the tune of $ 3 million in co-promotion fees. Finally, in May of 2006, the FDA issued a recall alert regarding bowel cleansing products associated with kidney failure. But it was not until December of 2008, that CB Fleet Company, Inc.. Recalled their OTC colonoscopy preparation solution Fleet Phospho-soda kiln days after the FDA issued warnings stating that Stricter Fleet should not be available as an OTC laxative prep for colonoscopy but that the oral sodium phosphate solutions should be given only by prescription. Even at that, the FDA will now require these solutions to contain black box warnings as to the serious side effects of kidney damage. What prompted the FDA to act with this harsh warning was 21 reports from patients that developed kidney failure after using the product.

Symptoms of acute phosphate nephropathy (kidney failure) can include malaise, lethargy, drowsiness, decreased amount of urine, and swelling of the ankles, feet and legs. Kidney problems can occur as soon as within a few days or as long as a few weeks after taking the Fleet product. CB Fleet Company brought in $ 213 million in non-prescription drug sales in 2007 and it manufactures over 100 different products that are distributed to over 100 different countries in the world. Approximately two hundred lawsuits have been filed against Fleet for the company's negligence in responding to patient reports that their product was causing kidney failure.

Recently, in Virginia, Fleet settled one lawsuit for $ 10 million for one plaintiff who Suffered Damage from the kidney of Fleet Phospho-soda. Several law firms have filed over 50 lawsuits against other marketing for Fleet Phospho-soda at higher dosages than the FDA permitted. Your laxative you hurt?
Fleet Phospho-soda is an over-the-counter laxative product that has been manufactured and marketed by CB Fleet Company for over a hundred years. These products have been approved by the FDA for the use of laxatives at a lower dose and appear to be safe.
However, problems began to occur in the 1990s, when CB Fleet Company began teaming up with pharmaceutical companies to mass market the product in double doses to doctors' offices and clinical gastroenterologist through countries as a solution in preparation for a colonoscopy, something the FDA has never given its approval.

Fleet Phospho-soda works drawing fluid from all parts of the body and transfer it into the colon and creating a laxative effect. In higher doses, calcium-phosphate crystals form in certain parts of the kidney called the renal tubules causing permanent kidney damage or kidney failure. This results in the patient having to undergo kidney dialysis for the rest of their lives, unless a suitable donor is found and the patient survived a kidney transplant.

The first sign of concern came from a team of doctors in New York in 2003. At that time, they reported a definite link between kidney damage and product fleet. Two years later, in 2005, the FDA issued a warning Benin there is a possibility of kidney damage resulting from the use of tablets or sodium phosphate solution as an intestinal cleanser. But the company continued to market its products more aggressively in August 2007 when he agreed to pay SANTARUS, Inc. to help push the drugs to doctors about 3 million dollars in costs of co-promotion. Finally, in May 2006, the FDA issued an alert reminder about cleaning the colon associated with renal failure.

But it is only in December 2008 that CB Fleet Company, Inc. reiterated their OTC solution for colonoscopy preparation Fleet Phospho-soda four days after the FDA issued stricter warnings stating that the fleet should not be available as a prep counter laxative for colonoscopy, but that the oral solutions of sodium phosphate should be administered by prescription. Even so, the FDA will now require that these solutions contain black box warnings about serious side effects of kidney damage. This prompted the FDA to act with that stern warning was 21 reports from patients who developed renal failure after using the product.
Symptoms of acute phosphate nephropathy (kidney disease) may include malaise, lethargy, drowsiness, decreased amount of urine, and swelling of ankles, feet and legs. Kidney problems can occur when a few days or as long as a few weeks after taking the product of the fleet. CB Fleet Company brought in 213 million dollars in sales of prescription drugs in 2007 and manufactures over 100 different products that are distributed to over 100 countries worldwide. Approximately two hundred lawsuits have been filed against the fleet of the negligence of the company to respond to reports of patients that their product was causing kidney failure.
Recently, Virginia, Fleet paid a further $ 10 million to a plaintiff who has suffered kidney damage from Fleet Phospho-soda. Several law firms have filed more than 50 other lawsuits against Fleet Phospho-soda market in higher dosages than the FDA approved.

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