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Colonoscopy Preps, Visicol and OsmoPrep, Linked to Kidney Problems
Dec 17, 2008 | Parker Waichman Alonso LLP
Visicol and OsmoPrep, prescription sodium phosphate medications that many people take as a bowel prep before a colonoscopy, have been linked to acute kidney damage. The problem recently prompted the Food & Drug Administration (FDA) to order that the drugs' makers include black box warnings on their labels about kidney risks.
The FDA also said it had seen similar kidney problems in people who used over-the-counter sodium phosphate products as bowel preps, and recommended they not be used for this purpose. The FDA said it planned to amend the labeling conditions for over-the-counter OSP products to address this concern with bowel cleansing use. As a result, C.B. Fleet Co. announced a voluntary recall of over-the-counter Fleet Phospho-soda products last week. Fleet Phospho-soda is a non-prescription laxative, but it is often used in larger doses has been used for bowel-cleansing.
In 2006, the FDA issued a Science Paper and a Healthcare Professional sheet describing the risks associated with the use of oral sodium phosphate products for bowel cleansing. Since then, as part of the agency’s postmarketing surveillance, the FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep. Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The FDA said the onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use, the agency said.
The FDA also warned that oral sodium phosphate products should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate. Finally, the agency recommended that oral sodium phosphate prescription products be used with caution for bowel cleansing by the following at risk groups:
- people over 55 years of age,
- people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and
- people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medication
Defective Drugs
