Bowel cleansing drugs may damage kidney

FDA has required black label warning on two colon cleansing drugs used for the colonoscopy. These prescription drugs may cause renal impairment, the U.S. Food and Drug Administration said Thursday.

A black-box warning is know required on the orally administered sodium phosphate products Visicol and OsmoPrep, informing patients about the possible risk of acute phosphate nephropathy, a type of acute kidney injury.

“Twenty distinctive cases of renal injury coupled with the use of OsmoPrep have been reported to FDA,” Dr. Joyce Korvick, deputy director of FDA said. “Among these cases, three were biopsy-proven cases of acute phosphate nephropathy. The initiation of kidney dysfunction in these cases varied, occurring within the several hours of use of these products and in some cases up to 21 days after the use of the drug.”

In routine, patients of constipation take oral sodium phosphate products. These drugs can either be prescribed or OTC (over the counter), to clean the large intestines before a colonoscopy or used as a laxative.

“The FDA is warning, that consumers should not use OTC preparations for bowel cleansing without consulting to your physician,” Korvick said. Instead, use alternatives bowel cleansing preparations.

Dr. Hemant K. Roy described the findings as “quite alarming.”

“Colonoscopies save lives,” he said. “So this should not deter people from doing one. I my opinion, we have to be more cautious about the kind of preparation we use and type of patient whom we are giving it to, so that an extraordinarily rare complication is avoided. And we have options, so there is a way to do that.”