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

[Guest guest]

And how nervous are you worrying vice finding out for sure?? I put off a

followup MAmmo for the same reason. So I worried my self sick for a month -

only to find that it was NOTHING.

On Thu, Dec 25, 2008 at 8:14 PM, wrote:

> 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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