Oral Sodium Phosphate Kidney Injury Warning Issued in Canada
Health 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 injury when used as a bowel cleanser at high doses.
The drug regulatory agency in Canada issued a statement on March 5, 2009, warning that Canadians should not use these oral sodium phosphate products for bowel prep unless they are specifically recommended by their doctor in an individual case.
Although the products appear to be safe when used at lower doses as a laxative, when used to cleanse the bowels as part of colonoscopy prep or before other medical procedures, oral sodium phosphate side effects could a serious kidney injury known as acute phosphate nephropathy. This could result in renal failure, the need for dialysis treatment, a kidney transplant or death.
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Learn MoreIn Canada, there are three authorized oral sodium phosphate products that are labeled for laxative use and as a bowel cleanser, Phoslax, Fleet Phospho-soda Oral Laxative and Phosphate Solution, which is sold as Pharmasave Phosphates Solution, Option + Phosphates Solution and Reserve Phosphates Solution.
Health Canada reports that they have received reports of at least 53 oral sodium phosphate adverse reactions, with 30 of them involving kidney problems and 27 of those reported as serious. Allergic reactions, gastrointestinal symptoms, neurological and cardiovascular problems were also reported as other adverse effects.
In the United States, the FDA issued a warning about the risk of kidney injury from oral sodium phosphate products in December 2008, and required that two prescription products add a “black box” warning about the risk of acute phosphate nephropathy, which is the strongest warning that can be placed on a prescription product.
In a statement released by the FDA on December 11, 2008, the U.S. drug regulators also indicated that over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, should not be used as a bowel prep due to the potential side effects.
The same day the FDA warned about the risk of kidney problems, a Fleet Phospho-soda recall was issued and the manufacturer, C.B. Fleet, indicated that they will stop selling the product as an over-the-counter laxative, but may seek approval to market the product as a prescription drug.
Since 2004, nearly 200 Fleet Phospho-soda lawsuits have been filed in the United States in various state and federal courts alleging that the manufacturer failed to warn that using high doses of the over-the-counter laxative as a bowel prep for colonoscopies could lead to potentially life-threatening kidney injury.
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5 Comments
anneJuly 16, 2010 at 2:55 pm
My son who had lifelong Cerebral Palsy was prescribed enemas to be given by me whenever necessary-daily if needed. He died at the age of 26 from the effects of a sodium phosphate enema. Had I known of the dangers of this over the counter product I never would have used it. His electrolytes were never monitored by the doctors he saw and I was never educated on the dangers of heart failure caused by[Show More]My son who had lifelong Cerebral Palsy was prescribed enemas to be given by me whenever necessary-daily if needed. He died at the age of 26 from the effects of a sodium phosphate enema. Had I known of the dangers of this over the counter product I never would have used it. His electrolytes were never monitored by the doctors he saw and I was never educated on the dangers of heart failure caused by this product.No one would help me in a lawsuit against Fleet as I did not have an autopsy done on my son. I live with this guilt and pain every day' I'm so glad to see this come to light.
DarwenJanuary 25, 2010 at 4:16 pm
in 2005 i had a series of colonoscopies done trying to find out what the problem i had with my abdomen was . Each time i was given an oral phosphate solution to clean the bowel in prep for the procedure . What started out as a case of diverticulitis quickly turned into more serious complications . I was operated on january 6/ 2006 and they were supposed to remove 18 inches of sigmoid colon , the [Show More]in 2005 i had a series of colonoscopies done trying to find out what the problem i had with my abdomen was . Each time i was given an oral phosphate solution to clean the bowel in prep for the procedure . What started out as a case of diverticulitis quickly turned into more serious complications . I was operated on january 6/ 2006 and they were supposed to remove 18 inches of sigmoid colon , the area they felt that was the problem . What they found were several perferations in my husbands large intestines . They removed the 18 inches of sigmoid colon but also removed 31/2 feet of his large intestine , they moved his galbladder and removed his appendix as well as giving him a tempory acsending illeostomy which they reversed 4 months later . Prior to the operation there were no indications of any perferoations in his large intestines . 00Since the original operation my husband has had several more colonoscopies and further problems with his abdominl wall . In 2007 another operation was performed due to the ongoing severe pain i had been suffering since the first operation . This time they found some hernia sites and some additional perforations to the abdominal wall . The doctors words were it looked like swiss chees in there . The doctor placed a mesh into my husbands abdomen from mid point in the front to mid point in the back to hold eveything in place . Since the first series of test and operations my husband has lived in severe chronic pain . My husband was given the phosphate solution in prep for his colonoscopies and his operations . Since this all began my husband can no longer work , he can't lift , bend do anything that requires the use of the abdomen . He lives in chronic pain all the time . Is there anything that can be done , he did not ask for this .
LindaApril 1, 2009 at 7:48 pm
I was just diagnosed with Chronic Kidney disease and had a colonscopy a few months ago. I used the fleet phosphate preparation.
StevenMarch 29, 2009 at 4:07 pm
Just diagnosed with chronic kidney failure. Had several colonoscopies, the last one about 2-3 years ago. Is there a Canadian class action suit going on?
ElmerMarch 13, 2009 at 4:17 pm
I used the Fleet enema 5 years ago in preparation for a colonoscopy examination. My doctor has told me that I have chronic (but not complete) kidney failure, although it has been stable for the last 4 years. Having had regular annual check ups for the last twenty five years, there was no indication of a kidney problem prior to the colonoscopy examination.