FDA Alert

On May 5th, 2006, the FDA issued an "alert" regarding the occurrence of Acute Phosphate Nephropathy after the ingestion of sodium phosphates solution or tablets.

The FDA said that the individuals most at risk for this type of acute renal failure, are the elderly, persons with kidney disease or a subnormal intravascular volume, and patients using a medication that affects renal perfusion or function—a diuretic, angiotensin-converting-enzyme inhibitor, or angiotensin-receptor blocker or possibly a nonsteroidal antiinflammatory drug.

According to a 2005 FDA "science background" paper, a bowel-cleansing regimen of oral sodium phosphates has systemic effects:
   • It causes dehydration;
   • Decreases the volume of fluid in the blood vessels; and
   • Burdens the bloodstream with an excessive amount of phosphates.

In turn, the bloodstream's burden becomes the problem of the renal tubules, which have a abnormally low amount of fluid because the body has been reabsorbing the tubules' water to correct the intravascular volume.

The FDA stated that the result is abnormally high concentrations of divalent calcium and phosphate ions in the renal tubules' fluid -high enough to precipitate calcium phosphate crystals and damage the kidney.

There are at least 21 proven cases of acute phosphate nephropathy in patients who ingested an oral sodium phosphates product that have been reported in the medical literature, FDA said. Furthermore, the FDA said that in nearly all of the cases the oral sodium phosphates product that caused the damage was Fleet’s Phospho-soda, which Fleets claims is the "leading bowel purgative."

If you or a family member have suffered Kidney Disease, Kidney Injury, Renal Failure, or End Stage Renal Disease following use of Oral Saline Laxative such as Fleet® Phospho-Soda® and other Over-the-Counter or prescription medications, contact Laszlo & Associates, LLC, immediately to discuss your legal rights - you may be entitled to monetary compensation.

 
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