FLEET PHOSPHO-SODA kidney failure
C.B. FLEET COMPANY has announced a voluntary recall of their over the counter products Phospho-Soda; EZ Prep Bowel Cleansing System.
Sodium phosphate is the base ingredient for a number of laxatives or bowel cleanser products now on the market. Often these are provided to patients in large doses prior to a colonoscopy examination. Some are sold over the counter and others are available by prescription only, but all of them have come under intense scrutiny by the FDA due to protracted reports of acute kidney damage caused by their use.
C.B. Fleet’s Phospho-soda is the most widely used of these bowel cleansers, sold over the counter and widely suggested by physicians to their patients to be used in large doses prior to colonoscopies. Fleet’s product was withdrawn from the market on December 15th of 2008, four days after the FDA issued a strong warning about the potential dangerous side effects of Phospho-soda and other sodium phosphate based laxatives.
The warning included an order for “black box” warnings to be included with the packaging of Fleet’s product and other laxatives including Visicol and OsmoPrep, two similar prescription bowel cleansers sold by Salix Pharmaceuticals. This FDA alert followed a less stringent warning from the Agency in 2005 citing the possibility of “acute phosphate nephropathy after the ingestion of sodium phosphates solution or tablets.”
Fleet has been the target of close to two hundred bowel cleanser lawsuits, all focused on the company’s negligence in responding to reports that their Phospho-soda product was causing severe kidney damage in certain patients. Fleet settled one ten million dollar suit in Virginia recently, brought by a plaintiff who suffered irreversible kidney damage due to the interaction of Phospho-soda and the plaintiff’s heart medication.
Fleet’s bowel cleanser lawsuits also allege that the drug company marketed Phospho-soda at dosages higher than the FDA permitted for over the counter oral laxatives containing sodium phosphate — up to twice the permitted daily amount according to these lawsuits.
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