FDA Black Boxes Bowel Cleansing Product Used for Pre-Colonoscopy

There is news that the FDA issued a black box warning on OsmoPrep, a product that markets itself as a pre-colonoscopy item. The U.S. Food and Drug Administration found that the product could cause kidney damage.

OsmoPrep and Visicol contains an ingredient called sodium phosphate, a substance that is known to cause major kidney damage. There have been a lot of cases and complaints that implicate OsmoPrep to kidney damage. Biopsy done to patients who have used OsmoPrep were revealed to have some kidney injury that is related to the use of the product. The cases have shown clear phosphate nephropathy, an indication that there is damage in the kidneys. Patients reported symptoms appeared a couple of hours after using the product while there are also those who claimed to feel something after 21 days of using it.

The product's manufacturer, Salix Pharmaceuticals have been asked by the FDA to conduct further tests and studies regarding the product. The government agency has has asked the manufacturer to issue warnings to go with the product.

Another product that has also caused the FDA to be concerned is called Fleet Phospho-soda from C.B. Fleet Co. This, however, is a product that is related to bowel cleansing and not really part of a pre-colonoscopy preparation. The FDA has asked the makers to attach a warning to the product so as to warn users about potential danger.