Kidney Damage with Fleet Phospho-soda
Did you know that the FDA has identified 21 cases of severe kidney damage and kidney injury among individuals who used oral sodium phosphate solutions like Fleet Phospho-soda and Fleet Accu-Prep, which can develop between several hours and 21 days after using the product for colonoscopy prep. In 2006, the FDA issued an alert about the risks of kidney problems with oral sodium phosphate products, recommending that prescription products be used with caution among patients with impaired kidney function. Although it was known that the use of high doses of the non-prescription Fleet Phospho-soda posed the same kidney risk, C.B. Fleet failed to adequately warn of the problems. In December 2008, the FDA indicated that they are requiring the makers of two prescription oral sodium phosphate drugs, Visicol and OsmoPrep, to add black box warnings about the risk of acute phosphate nephropathy and to develop a risk evaluation and mitigation strategy so that patients are made aware of the risks and benefits of using these products instead of other alternatives for bowel cleansing.
The same day, C.B. Fleet announced a Phospho-soda recall, since the FDA determined that oral sodium phosphate products should only be available for bowel prep by prescription. The recall was issued for:
- Fleet Phospho-Soda Oral Saline Laxative, Unflavorded 1.5 oz
- Fleet Phospho-Soda Oral Saline Laxative, Ginger-Lemon, 1.5 oz
- Fleet Phospho-Soda EZ-Prep Bowel Cleansing System
The company had previously agreed to stop selling Fleet Phospho Accu-Prep in 2006.
TRADEMARK NOTICE: Visicol, OsmoPrep, Fleet Phospho-Soda are trademarks of C.B. Fleet Corporation.
The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with C.B. Fleet Corporation. The use of this mark is solely for informational and product identification purposes.
