Colonoscopy Prep WARNING

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Date Joined Aug 2008
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   Posted 12/12/2008 5:55 PM (GMT -6)   
Some information about Prep options we all need to know and be aware of.



FDA Puts Black-Box Warning on Bowel-Cleansing Drugs
By Steven 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 Morrisville, 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 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.

"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.

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, Evanston-Northwestern Healthcare, Evanston, Ill.
Dx'd with UC, 1998 & IBS, 1999
Asacol, probiotics, vits. and whole foods diet

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Date Joined Aug 2007
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   Posted 12/12/2008 6:13 PM (GMT -6)   
Yeah, my doc was just telling me about this yesterday. He wants to use the Miralax prep. I've always used Phosphosoda in the past.
Diagnosed with ulcerative colitis spring 1999.
Maintenance dose sulfasalazine.
Probiotics, l-glutamine and fish oil caps. George's aloe vera juice. Oregano oil antibiotic, antiviral, antifungal. Long-term remission with only minor blips.

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Date Joined Mar 2007
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   Posted 12/12/2008 11:44 PM (GMT -6)   
I stay off the phosphasodas like the plague now and stick to the Go-Litely type chug-fests for that reason. Also, I do notice that chugging the Go-Litely is MUCH MUCH gentler on my bowels... virtually no cramping, in contrast to the severe cramps I got using phosphosodas. Given that fact, it seems copmmon sense that the GolLitely is much gentler on the inflamed gut, in my opinion.
Pancolitis ~20 years, once had a full med-free 10 year remission,
but flaring/simmering on and off for years, allergic to all 5ASAs
10 20 17.5 15 12.5 10 mg 8 7.5 20 17.5 15 mg pred, 100 mg Imuran
TCM, Probiotics (PD, Cust.Probiot., Culturelle, VSL3, etc), DMSO, TSO, hookworm
Turmeric/circuminboswellia, fish oil, many vits/minerals
Lower-carb version of Specific Carb Diet (SCD), Remicade newbie

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   Posted 12/13/2008 7:22 AM (GMT -6)   
Wow that's sort of scary! I used Osmoprep for my last scope and I thought it to be much easier to handle then phososoda - figures, when I find something that is easier it is found to be dangerous! :)
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Date Joined Mar 2007
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   Posted 12/13/2008 10:43 AM (GMT -6)   
Thanks for posting. I've only used GoLytely. My doc. said that was the safest one to use.
Diagnosed with UC March 2007; Asacol 4 tablets 3x/day; Rowasa; Canasa; Viactiv; Metamucil wafers; multivitamin; sublingual allergy drops

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Date Joined Aug 2006
Total Posts : 6571
   Posted 12/13/2008 10:56 AM (GMT -6)   
wow!  that is scary.  i used those osmoprep tablets for the last three times i had to do that.  I know it says shows up with in 21 days, but i wonder if it does other damange to your kidneys?
I mean, you know it's bad for you, because nothingthat makes you poo like that is natural or good for you!
Makes me sooo glad i never have to do that again, lol.

IBD/IBS Author
Regular Member

Date Joined Aug 2008
Total Posts : 20
   Posted 12/13/2008 12:10 PM (GMT -6)   
An even easier and gentler colon prep for some is the Miralax/Dulcolax prep. Amazingly, not all GIs are "up" on this prep, but they should be. Talk to your GI about it, you can also Google it and see what it involves.
Dx'd with UC, 1998 & IBS, 1999
Asacol, probiotics, vits. and whole foods diet

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Date Joined Aug 2008
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   Posted 12/13/2008 6:45 PM (GMT -6)   
      My GI doctor ALWAYS has me take the NuLitely (or is it Golightly).  Anyway, that gallon jug of yuk we have to drink.  For three days ahead of time, I eat very little or sometimes just have jello and soups.  Then, the day of the prep, I only have to drink about 1/3 of the stuff.  Works like a charm.
62 yr old granny. South Jersey
Diagnosed with ulcerative proctitis in 1998 in hospital
Hospitalized (2nd time) in May 2008
Update 11/03/08...finally in remission!!  Hope I don't jinx myself.  Off the prednisone since 11/01/ see if I can stay off for longer than two weeks.  Other meds: 6MP (75 mgm), colazal (6 per day), Benicar and Toprol (high blood pressure meds), Probiotic (2 per day), fish oil capsule and multi-vitamin and calcium with vitamin D.

Old Hat
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Date Joined Feb 2007
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   Posted 12/14/2008 6:08 PM (GMT -6)   
Thanks very much for posting this!!!!!!!!!!! It's extremely important!!!!!!!!!!!!!! Apart from kidney issues, Phosphosoda can irritate the bladder, giving the patient urinary urgency for a while after c-scope is over & done with. My gastroenterologist, who subspecializes in IBD treatment, leans toward Halflytely or Mirelax prep. Even the Halflytely dosage has recently been lowered by the manufacturer, from 4 pills to 2. I think the prep should not be "one-size-fits-all", especially when IBDers are known to have what doctors call "heterogeneity of response" to meds-- so we do to laxatives, too. Not everyone has a 4-6 foot long colon. / Old Hat (nearly 30 yrs with left-sided UC ... [etc.])
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