WASHINGTON - The Food and Drug Administration has received reports of a rare but serious form of kidney failure among patients taking prescription drugs used to cleanse the bowel before colonoscopies.
Federal health officials will add stern safety warnings to these oral phosphate products to indicate that drugs such as Visicol and OsmoPrep should be used with caution. Those at risk are older patients, people who suffer from dehydration, people who have kidney disease, and people who take medications that affect the kidneys.
Regulators said they are also concerned about the kidney risks from over-the-counter bowel cleansers. Most of these are only labeled to treat constipation, but regulators believe they are often used at higher doses to clear the colon.
"The available data do not show a risk of acute kidney injury when these 'over-the-counter' products are used at the lower doses for laxative use," the FDA said in a statement. "However, when used for bowel cleansing, these products have the same risks as prescription [drugs].” Consumers should not use over-the-counter products for bowel cleansing.