Colonoscopy Prep Warning: Oral Sodium Phosphate Risk of Kidney Injury
The FDA has asked that a black box warning about a possible risk of acute kidney injury will be added to Visicol and OsmoPrep, two oral sodium phosphate products used for bowel cleansing during colonoscopy prep. In addition, the agency indicates that over-the-counter oral laxative sodium phosphate products, such as Fleet Phospho-soda, should not be used for bowel cleansing due to the kidney risks.
Oral sodium phosphate (OSP) products are commonly used before a colonoscopy and other procedures to clear out the bowels before the examination.
The FDA announcement comes after the agency received a number of reports of a rare, but serious, side effect of the colonoscopy prep, involving a type of kidney injury known as acute phosphate nephropathy. This is caused by the formation of phosphate crystals within the renal tubules, potentially leading to kidney failure.
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Learn MoreVisicol and OsmoPrep, which are brand name prescription oral sodium phosphate products, will carry the new Boxed Warning about the risk of kidney injury from the colonoscopy prep products when used to cleanse bowels. The agency is also requiring the manufacturers of these products to develop a risk evaluation and mitigation strategy and to distribute a Medication Guide to all patients receiving the products.
The FDA has also indicated that they are equally concerned about the use of over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, which could cause kidney damage when used at higher doses for bowel cleansing. Therefore, the FDA is recommending that Fleet Phospho-soda and other over-the-counter products not be used for bowel cleansing.
Available data does not suggest that the use of these over-the-counter products pose a risk of kidney damage when used at lower doses as a laxative, and they have a long history of safe use for this purpose.
The FDA indicates that oral sodium phosphate products should not be used by children under the age of 18, or in combination with other laxative products containing sodium phosphate.
The agency is also recommending that prescription colonoscopy prep products not be used for bowel cleansing in people over 55 and those who suffer from dehydration, kidney disease, acute colitis or delayed bowel emptying. They also should not be used by people taking medications that affect kidney function.
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24 Comments
R. DougAugust 19, 2012 at 12:59 am
Within a week or so Ive had real bad some severe pain hip and down my leg to the top of foot. Also I have had double vision. And this has all been sense I had the coloncopy. I,m 67 years old and never been in this much pain. Some days it,s 3 or 4 hours before i can walk.
julieNovember 15, 2011 at 9:34 am
i had a colonoscopy on 31/10/11 and was violently sick after taking both bottles of fleet phosphate, dizzy light headed ever since also i have developed a severe rash all over my body which is spreading by the day the itch is driving me crazy. could this have anything to do with the phosphate?? my doctor says it wont be because of that?
EnzoOctober 9, 2010 at 8:04 pm
My wife took sodium phosphate prep drink before her colonscopy recomeded by her clinic. 2 days after her procedure, was rushed to the hospital with kidney failure. This could of been fatal. Creatitine blood level was 605 normally hers is 75. 12 days later now at home with 383 Craetitine level and still very high. Wondering what kidney damage this has caused her. With all these warnings out there, [Show More]My wife took sodium phosphate prep drink before her colonscopy recomeded by her clinic. 2 days after her procedure, was rushed to the hospital with kidney failure. This could of been fatal. Creatitine blood level was 605 normally hers is 75. 12 days later now at home with 383 Craetitine level and still very high. Wondering what kidney damage this has caused her. With all these warnings out there, she was a victim of negligence.
LauraOctober 16, 2009 at 3:25 am
Just got done taking this med and am going in for my procedure tomorrow! I'm so freaked out by all of this and wish i would have read it b4 taking these pills!
debOctober 6, 2009 at 8:34 pm
I have had yearly colonoscopies for the past 10 years and started w/ the OTC Fleets phospha-soda. Graduated to the oral pills maybe about 6-7 years ago WITHOUT ANY PROBLEMS. I've taken both Visicol and OsmoPrep. NO PROBLEMS what so ever. Just followed the directions, drank more water/fluids than recommended and am just fine. If you go to a good internist that periodically tests your liver fun[Show More]I have had yearly colonoscopies for the past 10 years and started w/ the OTC Fleets phospha-soda. Graduated to the oral pills maybe about 6-7 years ago WITHOUT ANY PROBLEMS. I've taken both Visicol and OsmoPrep. NO PROBLEMS what so ever. Just followed the directions, drank more water/fluids than recommended and am just fine. If you go to a good internist that periodically tests your liver function and kidney function (simple blood tests) you may have been alerted to prior developing problems w/ your kidneys and liver. Quite possibly increased problems developed co-incidently at the same time as you all received a colonoscopy. WHO KNOWS....... All FDA approved drugs have some adverse side effects for a relative few compared to the total number of users, and if all drugs were pulled off the market because of this then there would be NONE out there. You put anything in your body and you take a chance of a reaction - no matter what it is, that's just a part of life.
lauraSeptember 3, 2009 at 2:44 pm
Had a colonoscopy in june of 2006. Never associated symptoms with the procedure. Have experienced extreme fatigue, constant weight loss, heart palpitations and sharp pains in head. Had tests done for possible causes but nothing was found. Will schedule an appointment to have Kindeys tested.
cherylJuly 28, 2009 at 9:17 pm
I took visicol and ended up in the hospital with a seizure and in the hospital. I followed the directions to the letter. Call my doctor after the first dosage because I was running clear and he said to continue with the dosage. this was at 1:15 pm by 7:15 pm and before the final dosage I was swelling in the face, feet and hands and , tingling, and dizzy. My husband call the doctor and said he was[Show More]I took visicol and ended up in the hospital with a seizure and in the hospital. I followed the directions to the letter. Call my doctor after the first dosage because I was running clear and he said to continue with the dosage. this was at 1:15 pm by 7:15 pm and before the final dosage I was swelling in the face, feet and hands and , tingling, and dizzy. My husband call the doctor and said he was taking me to the hospital. I had just got to the emergency room and had a seizure. they admitted me and I requested a 48 hour brain scan to be performed later that week to make sure no brain damage. I would like for this to be taken off the market.
BarbaraJuly 27, 2009 at 4:01 am
I have had two colonoscopies within three years and took phosposoda both times. Immediately after the test, the doctor said that I should follow-up in three years, but at the office meeting two weeks later, he looked pensive and then suddenly smiled and said that I wouldn't have to come back for five years. I felt a loss of trust at that point. I have had memory problems and have not felt well for[Show More]I have had two colonoscopies within three years and took phosposoda both times. Immediately after the test, the doctor said that I should follow-up in three years, but at the office meeting two weeks later, he looked pensive and then suddenly smiled and said that I wouldn't have to come back for five years. I felt a loss of trust at that point. I have had memory problems and have not felt well for some time. I am following up with doctors to find out why my legs are so fatigued that I cannot climb stairs some times and my feet are in constant pain. I have had a weight gain and hate that my stomach protrudes so much and never thought about the air stretching my stomach wall. I have had pain in my sides that keep me from functioning and even walking. I have had a number of tests and have a couple of more to complete. So far they find nothing. After one blood test, a doctor asked me if I was a heavy drinker because the test showed my liver to be that of an alcoholic. He never did a follow up test or told me to follow up with any other doctor. I am concerned.
CherieJune 29, 2009 at 2:14 am
I too have had memory loss and I have developed a hard bladder wall and got MRSA also from the colonoscopy. I came out of the colonoscopy with tendinitis throughout my body and arthritis. I don't know if the damage is done from the Prep or the MRSA. My fever was 105 and I was given a triple anitbiotic drip. My stomach is now blown up as they put to much air in my colon and stretched my stomach [Show More]I too have had memory loss and I have developed a hard bladder wall and got MRSA also from the colonoscopy. I came out of the colonoscopy with tendinitis throughout my body and arthritis. I don't know if the damage is done from the Prep or the MRSA. My fever was 105 and I was given a triple anitbiotic drip. My stomach is now blown up as they put to much air in my colon and stretched my stomach wall and it has never gone back to normal. I had a flat stomach and no pain prior to my colonoscopy. It has changed my life forever.
SidneyJune 11, 2009 at 8:55 pm
I am 89 years old and lost a kidney to cancer about 5 years ago.. I had a colonoscopy scheduled for 6/15/2009. This was to be my first colonoscopy. After reading about the possible kidney problems I canceled. However, if you don"t have kidney problems and have a history of polyps you should consult with your doctor about which preparations to take prior to the procedure.
joanJune 2, 2009 at 6:27 pm
I had a bad reaction to osmoprep. After taking the initial dosage, I developed severe trembling and had to be hospitalized for two days. During this time I developed short term memory loss and since that time, I have continued to lose memory. I can find no examples of osmoprep causing dementia.
SharonMay 29, 2009 at 4:41 pm
After taking Fleet Phospho-soda. I experienced a burning feeling in my mouth and throat. I was very sick with fever and chillls and was sick for three weeks. I have a very sore mouth and my throat hurts to open. I have seen three Doctors look a my mouth,they are concerned that my mouth is damaged from the burns.
margieApril 27, 2009 at 2:20 pm
It's about time someone is taking some steps to correct the problem regarding the tests for colonscopy procedures. I had this test done and suffered with neausea and fatigue as I went into renal failure and almost lost both kidneys. I even had to have a biopsy done to determine how much damage had occurred. To this day I must have blood tests done to watch the creat count which had gone from 0.[Show More]It's about time someone is taking some steps to correct the problem regarding the tests for colonscopy procedures. I had this test done and suffered with neausea and fatigue as I went into renal failure and almost lost both kidneys. I even had to have a biopsy done to determine how much damage had occurred. To this day I must have blood tests done to watch the creat count which had gone from 0.8 to 3.3. and this all started in April of 2007.
MargieApril 27, 2009 at 2:03 pm
I had a colonscopy done on 4-16-07. I became very sick after . I was always tired and nauseated and found it very hard to do anything. My doctor sent me to kidney specialist and my creat count had gone from 0.8 to 3.2 and I was in renal failure and my kidneys would never be normal again. It is two years later and the count has now gone down to 2.1. I also had to have a renal biopsy done on 8-[Show More]I had a colonscopy done on 4-16-07. I became very sick after . I was always tired and nauseated and found it very hard to do anything. My doctor sent me to kidney specialist and my creat count had gone from 0.8 to 3.2 and I was in renal failure and my kidneys would never be normal again. It is two years later and the count has now gone down to 2.1. I also had to have a renal biopsy done on 8-15-07 to determine the damage done to the kidneys. (both). On 8-24-97, my evaluation of worsening reanl insufficiency with an incease of serum creatinie from 0.9 in 11/06 to 2.7 in 6-07 and 3.3 in 8-07 I had no prior history of renal disease. I think it is about time that someone does something about this test. It has caused so much damage to my kidneys and still am doctoring with blood tests constantly .
Colonoscopy Prep Kidney Failure Lawsuits Filed Over Fleet Phospho-soda - AboutLawsuits.comMarch 24, 2009 at 12:36 pm
[...] The lawsuits were filed on behalf of two women and two men from Virginia, with each case seeking more than $10 million in compensatory damages and $350,000 in punitive damages as a result of kidney problems caused by the colonoscopy prep. [...]
DOROTHYMarch 23, 2009 at 8:35 am
MY DIALYSIS DOCTOR RECCOMMENDED THAT HE WAS GOING TO SCHEDULE ME FOR A COLONOSCOPY. I IMMEDIATELY DECIDED NOT TO TAKE IT BECAUSE I AM IN DIALYSIS FOR ACUTE KIDNEY FAILURE. i TOOK BAYCOL BEFORE IT WAS RECALLED IN 2005. I WAS DIAGNOSED WITH ACUTE KIDNEY FAILURE AND HAVE BEEN IN DIALYSIS APPROXIMETELY ONE YEAR.
Oral Sodium Phosphate Kidney Injury Warning Issued in Canada : AboutLawsuits.comMarch 6, 2009 at 6:50 pm
[...] Canada has issued a warning about side effects of oral sodium phosphate products, such as Fleet Phospho-soda, as they could cause electrolyte disturbances and kidney [...]
Fleet Phospho-Soda Lawsuit Filed By Women Who Suffered Kidney Injury : AboutLawsuits.comFebruary 26, 2009 at 6:32 pm
[...] December 2008, the FDA issued a colonoscopy prep warning, indicating that the two prescription oral sodium phosphate products used for bowel prep, Visicol [...]
TinaFebruary 11, 2009 at 3:01 am
I had the colonoscope on October 1, 2008. I got violently ill with in an hour of getting home. Ended up in ER. Now I found out I have acute phosphate nephropathy. My new Kidney says we just have to watch it all my levels are off and I think something more should be done.
LorannieFebruary 9, 2009 at 10:50 pm
I have to have a colonogrpahy done and I was wondering if the pills are safe to take. I tried the liquid formula and did not succeed. My doctor does not recommend the pille. Has anyone had problems with the pills?
kellieJanuary 23, 2009 at 8:18 am
I have had a few preps using the oral fleet with ducolax tabs and a rectal clean out..my doctors are very well aware of my current kidney disease and I TAKE DAILY MEDS. now they say im in the last stages of this disease. which could last 1 - 25 years. approx 8 months ago I had another colonoscopy...ever since.. I go to doctor to complain about dizzy, extreme tired .nauses and not able to think c[Show More]I have had a few preps using the oral fleet with ducolax tabs and a rectal clean out..my doctors are very well aware of my current kidney disease and I TAKE DAILY MEDS. now they say im in the last stages of this disease. which could last 1 - 25 years. approx 8 months ago I had another colonoscopy...ever since.. I go to doctor to complain about dizzy, extreme tired .nauses and not able to think clearly as well contiued pain in kidneys and belly area..COULD THIS BE FROM ALLTHE PREPS I HAVE HAD
JanetJanuary 15, 2009 at 5:08 am
May 25, 2007 Prescribed Osmoprep for colonoscopy prep. Result Acute Kidney Failure. Hospitalized for 2 weeks. After 20 months, Stage 4 Kidney failure, 9 points from DIALYSIS. Chronic Fatigue, Chronic Puritis, Itching. Volitale Blood Pressures. Not Fun. Not worth the risk.
AlixDecember 16, 2008 at 1:19 am
I see a nasty dilemma here: go with the potentially kidney destroying oral sodium phosphate products or potentially get colon cancer. Neither option seems to solve right to ME.
LizDecember 13, 2008 at 6:06 am
I had the colonoscopy a week and a half ago--and took the fleet mirlax and ducolax tablets-- I drank allot of liquid prior to the test; however, since then I have a real bad back ache with allot of gas. I do not have the results from the test yet --but Dr. said things look ok. Should I have my kidneys test.