FDA warns about BOWEL PREP products

December 22, 2008 at 4:35 pm | Posted in ostomy | Leave a comment

Because of additional reports of serious kidney damage, the Food and Drug Administration (FDA) issued an alert on November 11, 2008 requiring that Black Box warnings be added to the labels for oral sodium phosphate prescription tablets Visicol® and OsmoPrep®. On December 11, 2008 the C.B. Fleet Company voluntarily recalled all their over-the-counter oral sodium phosphate products including Fleet Phospho-soda® and Fleet EZ-Prep™ Bowel Cleansing System.

When used for bowel cleansing before colonoscopy, the products can very rarely cause acute phosphate nephropathy, resulting in permanent kidney damage. 

See the FDA information, and access the page where you can file your own adverse event concerning any FDA-approved product, at http://www.fda.gov/cder/drug/infopage/OSP_solution/default.htm .

See more information from the Colorectal Cancer Coalition (C3) at this link.

So if your New Year’s Resolution includes having a colonoscopy or other colon text, please get a new recommendation from your physician for the bowel prep that will be needed.


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