colonscopy prep warnings from the FDA. Received today

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Canyonbabe711
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Date Joined Mar 2006
Total Posts : 1451
   Posted 4/13/2009 7:54 PM (GMT -7)   

Some of you may know this but I was not aware they had pulled Fleets Phospho Soda from shelves.

 

 

Stronger Warnings for Bowel Cleansing Agents

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FDA is announcing new safety measures for oral sodium phosphate (OSP) products used for bowel cleansing before colonoscopies and other procedures. These products are associated with acute phosphate nephropathy, a rare but serious type of kidney injury. The events have been reported with the prescription products Visicol and OsmoPrep, and also over-the-counter sodium phosphate products when they are used as bowel cleansers.

FDA first warned about this problem in 2006, but cases of kidney injury continue to be reported. So FDA is requiring the manufacturer of Visicol and OsmoPrep to take several steps. First, a boxed warning about the risk of acute phosphate nephropathy will be added to the product label. The manufacturer will also conduct a new clinical trial to further study the risk of acute kidney injury with these products, provide a Medication Guide for patients, and implement a risk evaluation and mitigation strategy to ensure that the benefits of using these products outweigh their risks.

FDA believes that oral sodium phosphate products should be available only by prescription when they are used for bowel cleansing. Because of this, C.B. Fleet Company has voluntarily recalled the company's oral sodium phosphate products sold over the counter, (Fleet Phospho-soda and Fleet EZ-PREP) and has advised healthcare professionals not to instruct patients to use these products for bowel cleansing. Unico Holdings, Inc. is also recalling its OTC oral sodium phosphate products sold for bowel cleansing.

Health professionals should use caution when prescribing Visicol or OsmoPrep for patients who may be at higher risk of kidney injury. This includes those over aged 55, or those who have kidney disease, bowel obstruction, active colitis, or are dehydrated. It also includes patients taking drugs that affect renal perfusion or function such as diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs) and possibly NSAIDS.

Prescribers should instruct patients about how to prepare for their procedures, and tell them to avoid dehydration by drinking enough clear liquids before, during and after bowel preparation. They should also tell patients to be alert for symptoms of acute kidney injury, including malaise, lethargy, drowsiness, decreased urine volume and swelling of the ankles, feet and legs.

Additional Information:

FDA MedWatch Safety alert. Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription). December 11, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#OSP

C.B. Fleet Company Press Release. C.B. Fleet Voluntarily Recalls its Fleet Phospho-soda Product after FDA Safety alert. December 11, 2008.
http://www.cbfleet.com/newsstory.php?id=8

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Keriamon
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Date Joined Jun 2005
Total Posts : 2976
   Posted 4/14/2009 9:11 AM (GMT -7)   
I would be interested to know, of the people who developed kidney problems directly related to the phosphosoda, how many only took it once for a procedure, versus how many had taken it multiple times as a colon cleanser? 
 
This is a really good point about how you shouldn't use laxatives unless you are actually constipated, or you need to have a certain mediecal procedure done.  People who are hung up on colon cleansing don't realize that it's just another word for "laxative," and you can get the same laxative-abuse problems attempting to make your colon perfectly empty as you can if you take them to lose weight. 
 
Something else that no one tells you when you take laxatives that strong is that you can wipe out your good bacteria in the gut and you can get bacterial infections as a result of bad bacteria taking over.  Doing it once causes a very low risk (although taking probiotics can fix that), but doing it regularly, or even frequently, can raise the risk. 

Canyonbabe711
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Date Joined Mar 2006
Total Posts : 1451
   Posted 4/15/2009 9:53 PM (GMT -7)   
Well, apparantly there had to be quite a few to take if off the market. I do know that I have been reading warnings about using it if you have kidney problems for sometime now but I sure wasn't aware it was off the shelf. Heaven only knows what my next prep will be. I had just figured out how to make it palatable and now will have to go thru it with something else. Fortunately have a couple years before next. Seems like they should be able to make something that tastes better.

7Lil
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Date Joined Apr 2005
Total Posts : 3269
   Posted 4/15/2009 10:01 PM (GMT -7)   
I'm with you! I have no idea what I'm going to use for my next prep. I'll have to put off my next scope until they find something palatable because Golytely will NOT do.
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