Fleet Phospho-soda Information Center: __________________ Symptoms of Possible Kidney Problems Acute Phosphate Nephropathy Oral Sodium Phosphate can cause Acute Phosphate Nephropathy Visicol and OsmoPrep Phospho Soda Kidney Damage with Fleet Phospho-soda Renal Failure Caused by Oral Sodium Phosphate Solutions Justice for those Injured by OSP We will work under a Contingency Fee Contract

The Food and Drug Administration has asked that a black box warning be placed warning of the possible risk of acute kidney injury.  The warning is being added to Visicol and OsmoPrep. Visicol and OsmoPrep are two oral sodium phosphate products used for bowel cleansing during colonoscopy prep. In addition, the agency indicates that over-the-counter oral laxative sodium phosphate products, such as Fleet Phospho-soda, should not be used for bowel cleansing due to the kidney risks. OSP or Oral Sodium Phosphate products are commonly used before a colonoscopy and other procedures to clear out the bowels before the examination.

MEDICAL ALERT: The FDA announcement comes after the agency received a number of reports of a rare, but serious, side effect of the colonoscopy prep, involving a type of kidney injury known as acute phosphate nephropathy. This is caused by the formation of phosphate crystals within the renal tubules, potentially leading to kidney failure.

Visicol and OsmoPrep, which are brand name prescription oral sodium phosphate products, will carry the new Boxed Warning about the risk of kidney injury from the colonoscopy prep products when used to cleanse bowels. The agency is also requiring the manufacturers of these products to develop a risk evaluation and mitigation strategy and to distribute a Medication Guide to all patients receiving the products. The FDA has also indicated that they are equally concerned about the use of over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, which could cause kidney damage when used at higher doses for bowel cleansing. Therefore, the FDA is recommending that Fleet Phospho-soda and other over-the-counter products not be used for bowel cleansing.

Available data does not suggest that the use of these over-the-counter products pose a risk of kidney damage when used at lower doses as a laxative, and they have a long history of safe use for this purpose. The FDA indicates that oral sodium phosphate products should not be used by children under the age of 18, or in combination with other laxative products containing sodium phosphate. The agency is also recommending that prescription colonoscopy prep products not be used for bowel cleansing in people over 55 and those who suffer from dehydration, kidney disease, acute colitis or delayed bowel emptying.

Visicol and OsmoPrep should not be used by people taking medications that affect kidney function.  For more information call our Law Firm at 1-800-862-1260.






























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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.