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FDA Puts Black-Box Warning on Bowel-Cleansing Drugs
Date:12/11/2008

s not use the over-the-counter preparations for bowel cleansing, but that these products be used under the direction of a physician," Korvick said.

She added that there are alternatives to these preparations that can be used for bowel cleansing, including GoLYTELY and HalfLytely Bowel Prep.

In 2006, the U.S. Food and Drug Administration put out an alert on oral sodium phosphate products, excluding OsmoPrep, recommending that they be "used with caution" among patients with impaired kidney function due to their high phosphate content.

The FDA said Thursday that oral sodium phosphate products shouldn't be used by children under 18 years of age, or in combination with other laxatives containing sodium phosphate. And the agency urged the following high-risk groups to use the products with caution:

  • 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 medications).

Earlier this year, researchers reporting in the Archives of Internal Medicine said the risks of oral sodium phosphate solutions and some oral sodium phosphate tablets were rare but real, particularly for elderly patients.

Dr. Hemant K. Roy, an associate professor in the department of medicine at Evanston-Northwestern Healthcare in Illinois, writing in an accompanying editorial in the journal, described the findings as "quite alarming."

However, he stressed that warranted concerns about phosphate solutions shouldn't keep patients from undergoing colon cancer screening.'/>"/>

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