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OsmoPrep Black Box Warning & Kidney Injury Lawsuit

Salix Pharmaceuticals manufacturers OsmoPrep, also known as the “The Tablet Prepâ€? (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP).  Salix markets OsmoPrep as “the latest advancement in colonoscopy preparation[.]â€?  OsmoPrep was approved by the FDA in March 2006 for cleansing the colon in preparation for colonoscopy in adults over the age of 18. 

OsmoPrep is advertised as being unique among bowel preps because it consists of a series of pills instead of a liquid prep and is taken with the clear liquid of the patient’s choice, allowing the patient to choose what the tablet will taste like  – not like an unpleasant liquid bowel prep.

On December 11, 2008 the U.S. Food and Drug Administration (FDA) announced that it was requiring the addition of a black box warning on oral sodium phosphate (OSP) products, including OsmoPrep regarding the potential to develop acute phosphate nephropathy.  OsmoPrep is

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manufactured by Salix Pharmaceuticals, Ltd.  Salix also manufacturers Visicol, another OSP, which also received a black box warning by the FDA on December 11.  The FDA further expressed concern about the use of related over-the-counter (OTC) laxatives such as Fleet Phospho-soda.  In response, C.B. Fleet voluntarily recalled Fleet Phospho-soda on December 11. 

Contact an OsmoPrep Kidney Injury Lawyer about an Acute Phosphate Nephropathy Lawsuit Today

If you or a loved one used OsmoPrep or another OSP and suffered from acute phosphate nephropathy, contact an OSP Lawyer, Visicol Lawyer or Fleet Phospho Soda Lawyer today for a confidential free case evaluation. 


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Osmoprep-oral-sodium-phosphate Quick Facts

Osmoprep-oral-sodium-phosphate Quick Reference Guide
Other Names: 

OSPs
Visicol
OsmoPrep
Oral Sodium Phosphate

Manufacturers:
Fleet

Status:
Black Box Warning

Approved Uses:
Colon Cleansing

Off-Label Uses:
n/a

Serious Side Effects:
Acute Phosphate Nephropathy