Phospho-soda Side Effects
C.B. Fleet’s Co.’s “Fleet Phospho-soda” and “Fleet Phospho-soda EZ-Prep Bowel Cleansing System” products have been linked to a serious condition known as acute phosphate nephropathy. This condition is caused by deposits of calcium phosphate crystals in the kidneys, which can form after using an oral phosphate solution (OSP) such as Phospho-soda. These crystal deposits can lead to impaired kidney function, which may cause permanent kidney damage or kidney failure.
After Fleet began marketing Phospho-soda for bowel cleansing before a colonoscopy, several studies found that use of the product could increase the risk of kidney damage. Although the FDA warned Phospho-soda users about the risk of renal failure from acute phosphate nephropathy in May 2006, Fleet took no action at that time to recall Phospho Soda from the market.
In December 2008, the FDA issued a warning notice about the risk of acute phosphate nephropathy with OSPs such as Fleet’s Phospho-soda after receiving several medical reports about the side effects of the product. In addition to requiring the manufacturers of prescription OSP solutions to add a “black-box” warning to these products, the FDA said that Fleet Phospho-soda should no longer be made available over-the-counter for bowel cleansing.
Shortly after the FDA’s warning, Fleet issued a recall notice for its “Fleet Phospho-soda” and “Fleet Phospho-soda EZ-Prep Bowel Cleansing System” products. The recall notice directed consumers whose doctors had recommended Phospho Soda for bowel cleansing to contact them for an alternative solution.