Phospho-soda Recall
In May 2006, the Food and Drug Administration issued a warning about the risk of acute renal failure for patients using oral sodium phosphate products (OSP) such as C.B. Fleet’s Phospho-soda. The agency cited 21 reports it had received of a condition known as acute phosphate nephropathy among OSP users. This condition is caused when calcium-phosphate crystals are deposited in the kidneys, leading to serious and potentially permanent kidney damage.
The FDA’s Phospho-soda warning highlighted a number of risk factors that could increase a consumer’s risk of developing kidney damage from acute phosphate nephropathy. These risk factors included: advanced age, pre-existing kidney diseases, and the use of medications that affect the kidneys, including diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs) and certain pain relievers known as NSAIDs.
Because of the increased risk of acute phosphate nephropathy among Fleet Phospho-soda users, the FDA announced that it would ban the sale of over-the-counter OSPs for bowel cleansing in December 2008. The agency cited medical reports it had received of Phospho-soda users with kidney injuries from acute phosphate nephropathy who had none of the apparent risk factors for the condition.
Shortly after the FDA banned the sale of over-the-counter OSPs for bowel cleansing due to the risk of side effects, C.B. Fleet announced that it would recall its Phospho-soda products because of the FDA’s safety concerns. The recall notice affected the sale of the products “Fleet Phospho-soda” and “Fleet Phospho-soda EZ-Prep Bowel Cleansing System.” The company advised patients to talk with their doctors about alternative bowel cleansing methods which did not carry the same risk of kidney damage.