Fleet Phospho-Soda Recall:
The use of oral sodium phosphate solutions like Fleet Phospho-soda have been linked to an increased risk of kidney injury, known as Acute Phosphate Nephropathy, which could lead to renal failure, the need for dialysis treatment, a kidney transplant or even death. In December of 2008, C.B. Fleet Company announced a Fleet Phospho-soda recall for their over-the-counter oral sodium phosphate laxative, which was being widely marketed for use at higher doses as bowel prep before a colonoscopy or other procedures. This followed an FDA warning issued about the risk of kidney damage the same day.
FDA Warnings Lead To Recall And Stronger Wanrings:
In December 2008, the FDA issued a warning about the use of oral sodium phosphate products like Fleet Phospho-soda as bowel cleansers.
The makers of two prescription oral sodium phosphate products, Visicol and OsmoPrep, were required to add a new black box warning about the risk of kidney damage, develop a risk mitigation strategy and provide medication guides to ensure that individuals are aware of the risks and alternatives before using these products.
Although Fleet Phospho-soda was an oral sodium phosphate solution which was available over the counter as a laxative, C.B. Fleet Co., Inc. heavily marketed and promoted their product for use at high doses for bowel prep. Use of the product at double the approved doses was never established as safe and the FDA would not have approved the product for over-the-counter use at those doses.
When the FDA issued their December alert, they indicated that over-the-counter laxatives like Fleet Phospho-soda should not be used for bowel prep and should only be available as a prescription. That same day, C.B. Fleet issued a Fleet Phospho-soda recall.
In 2006, the FDA issued a Science Paper and a Healthcare Professional sheet describing the risks associated with the use of oral sodium phosphate products for bowel cleansing. Since then, as part of the agency’s postmarketing surveillance, the FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep. Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The FDA said the onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use, the agency said.
The FDA also warned that oral sodium phosphate products should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate. Finally, the agency recommended that oral sodium phosphate prescription products be used with caution for bowel cleansing by the following at risk groups:
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people over 55 years of age,
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people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying
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people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medication )
Read FDA Phospho-Soda Alert >>>
What is Acute Phosphate Nephropathy?
Phosphate nephropathy consists of damage to the kidneys caused by the formation of phosphate crystals within the renal tubules, damaging the nephron, and can cause acute renal failure.
It frequently occurs following the ingestion of oral sodium phosphate solution such as Fleet Phospho-Soda, or prescription for bowel cleansing prior to a colonoscopy. The risk of this complication is increased with age, dehydration, or in the presence of hypertension or if the patient is taking an ACE inhibitor or angiotensin receptor blocker.
If you or a loved one have been injured or suffered as a result of using Fleet Phospho-Soda you may be entitled to compensation. Conatact the Fleet Phospho-Soda Lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Or by calling toll-free: 1-800-856-6405. Our experienced attorneys can answer any questions you may have about Fleet Phospho-Soda Recall, or a pending Fleet Phospho-Soda Lawsuit.
