FYI --- FDA & black box warning on bowel cleansing

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FDA Puts Black-Box Warning on Bowel-Cleansing Drugs

By Reinberg

HealthDay Reporter

Thursday, December 11, 2008; 12:00 AM

THURSDAY, Dec. 11 (HealthDay News) -- Two prescription drugs used to cleanse

the bowel before a colonoscopy may cause kidney damage, the U.S. Food and

Drug Administration said Thursday.

The FDA said it would now require a black-box warning on the oral sodium

phosphate products Visicol and OsmoPrep, alerting consumers about the risk of

acute phosphate nephropathy -- a type of severe kidney injury.

" The FDA has received reports of 20 unique cases of kidney injury associated

with the use of OsmoPrep, " Dr. Joyce Korvick, deputy director of FDA's

Division of Gastroenterology Products at the Center for Drug Evaluation and

Research, said during an afternoon teleconference. " Of the reported cases,

three

were biopsy-proven cases of acute phosphate nephropathy. 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 it has told the products' manufacturer, Salix Pharmaceuticals

of ville, N.C., to develop what's called a risk evaluation and

mitigation strategy, to distribute a medication guide for patients so they're

aware

of the risk of kidney injury, and to conduct a post-marketing clinical trial

to gauge the risk of injury.

The FDA also said it was concerned about similar non-prescription treatments,

such as Fleet Phospho-soda, made by C.B. Fleet Co. of Lynchburg, Va. These

treatments also shouldn't be used for bowel cleansing, and will get new

warnings. At lower doses, however, they are safe for use as laxatives, the FDA

said.

Patients routinely take oral sodium phosphate products -- either prescription

or over the counter -- to clean the intestines before a colonoscopy and

other medical procedures.

" The FDA is recommending that consumers 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

ton-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.

" Colonoscopies save lives, " he said. " We know it works. So this should not

dissuade people from doing one. I think we just need to be cautious about the

type of preparation we use and who we give it to, so that an extraordinarily

rare complication is avoided. And we have options, so there is a way to do

that. "

According to the American Cancer Society, colorectal cancer ranks third in

the United States in terms of cancer diagnoses among both men and women. The

organization estimates that about 150,000 people will develop the disease this

year alone.

More information

For additional information on colonoscopies, visit the _American Cancer

Society_

(http://www.cancer.org/docroot/CRI/content/CRI_2_6x_Frequent_Questions_About_Col\

onoscopy_and_Sigmoidoscopy.asp) .

SOURCES: Dec. 11, 2008, U.S. Food and Drug Administration teleconference with

Joyce Korvick, M.D., MPH, deputy director of FDA's Division of

Gastroenterology Products at the Center for Drug Evaluation and Research;

Hemant K. Roy,

M.D., associate professor, department of medicine, ton-Northwestern

Healthcare, ton, Ill.

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