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

[Guest guest]

Thanks for the info because I am needing to get a colonoscopy since

my diverticulitis attack. I just keep putting it off. I am nervous

they will find something wrong. Cyndi B

> 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_Colonoscopy_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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