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 it’s products and 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 wasn’t until December of 2008, that CB Fleet Company, Inc. recalled their OTC colonoscopy preparation solution Fleet Phospho-soda four days after the FDA issued stricter warnings stating that Fleet should not be available as an OTC laxative prep for colonoscopy but that the oral sodium phosphate solutions should only be given 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 harsher 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.
C.B. 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 kidney damage from the of Fleet Phospho-soda. Several law firms have filed over 50 other lawsuits against Fleet for marketing Phospho-soda at dosages higher than the FDA permitted.