Fleet Phospho Soda Recall
Fleet Phospho-Soda, an over-the-counter laxative that was recalled on Dec. 11, 2008 due to eveidence of the Fleet Phospo Soda was causing serious kidney failure, renal failure. More specilfically the kidney damage is called acute phosphate nephropathy. The acute phosphate nephropathy is caused when calcium-phosphate crystals deposit in the renal tubules, resulting in permanent renal function impairment and the need for chronic kidney dialysis.
The FDA has determined that, in light of the risk of acute phosphate nephropathy, over-the-counter laxative oral sodium phosphate (OSP) products such as Fleet Phospho-Soda and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System should not be used for bowel cleansing. After the FDA warning, C.B. Fleet Company immediately announced a voluntary recall of Fleet Phospho-Soda and Fleet® Phospho-soda® EZ-Prep®.
FDA Warns Consumers of Fleet Phospho-Soda Products
As a result of new safety information concerning Fleet Phospho-Soda and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System , the FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products.
FDA acknowledges that OSP products, in addition to use for bowel preparation, have a long history of safe use as non-prescription products as laxatives (i.e. for relief of constipation) and accordingly, they will continue to be available over-the-counter for this use. However, in light of the risk of acute phosphate nephropathy, over-the-counter laxatives with sodium phosphate (OSP) products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional. FDA intends to amend the labeling conditions for OSP products available in the OTC setting to address this concern with bowel cleansing use and to improve the safe use of OSPs that are available over-the counter.
Fleet Phospho Soda Kidney Failure Lawsuits
Call for a Free & Confidential Fleet Kidney Failure Lawsuit Evaluation. Talk to a Board Certified Personal Injury Trial Lawyer licensed in Texas and in New York with a National Presence. All cases are taken on a contingency fee basis and the client is never charged an attorney fee or any legal case expenses unless a recovery is obtained. We are handling a large number of these cases and understand the dangerous nature of this product and defect and we work hard for our clients.
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