..."/>

C.B. Fleet Recalls Its Over-the-Counter Phospho-soda Products

On December 11, 2008 the C.B. Fleet Company voluntarily recalled all their over-the-counter oral sodium phosphate products including Fleet Phospho-soda® and Fleet EZ-Prep™ Bowel Cleansing System.

The recall follows the Food and Drug Administration safety alert on Thursday connecting oral sodium phosphate bowel cleansers to acute phosphate nephropathy. In announcing the recall Fleet said,

The recall decision was made to address FDA’s determination that oral sodium phosphate solutions used for bowel preparation prior to medical procedures such as colonoscopy should only be available by prescription, and consumers should not be using over-the-counter products for bowel cleansing. Since Fleet’s Phospho-soda products are currently labeled and sold as over-the-counter products, Fleet decided voluntarily to remove them from the market as expeditiously as possible to address the FDA’s decision that the products be available by prescription only.

In addition, Fleet recommended that consumers not purchase Fleet’s Phospho-soda for bowel cleansing:

As FDA has recommended that doctors not direct their patients to use these over-the-counter products for bowel cleansing, C.B. Fleet requests that consumers not purchase these products for bowel cleansing and contact their physician for alternatives if their physician has recommended their use for this purpose.

In a letter to health professionals, C.B. Fleet requested that they immediately stop directing patients to use Fleet Phospho-soda or Fleet EZ-Prep for bowel cleansing.

Related posts

16 Comments

  1. Charlene said:

    I used the Phospho-soda on Dec 18th 2008.
    Am I in any danger?
    C Wasno

  2. Kate Murphy said:

    The risk of kidney damage from phospho-soda is very small. It is higher in people who already have some kidney problems and in the elderly, but it is still a rare problem.

    If you are worried, ask your doctor to do tests of kidney function. Your doctor can explain your risks to you.

  3. Nancy said:

    DO NOT USE THIS! My Dr told me to use this last year as a colonoscopy prep. Two weeks later I had a blood test because I was sick, I had kidney failure! I am now stage 4. This product should be taken completely off the market!!!!!!!! It kills your kidneys! It may be rare but why take a chance! I was fine before!

  4. Larry said:

    I have used Phosphate Soda for a laxative. I use only one tablespoon and it works every time.

    I have not had a worsening of my kidneys in any way.

    As a laxative in this minimal amount it is harmless.

  5. Kate Murphy said:

    The new FDA warning applied to the use of Fleet Phospho-soda products for bowel cleansing prior to medical procedures like colonoscopy.

    In the FDA Safety Alert on December 11, 2009, the FDA acknowledges that oral sodium phosphate has a long history of safe use as a laxative for the relief of constipation. FDA does not question their over-the-counter use as an occasional laxative.

    However, Fleet has decided to remove their products from over-the-counter shelves. Fleet Phospho-Soda will still be available by prescription for both laxative use and bowel cleansing when recommended by a physician.

  6. Steve Foley said:

    Phospho-soda when dosed at more than 45mL in 24hrs can cause renal failure. The total number of people afflicted is unknown, as it is likely an under-recognized cause of renal failure.

  7. john harbaugh said:

    I have been using Fleets phospho sodium for 32 years at my Dr.’s instruction … with a dosage of 4 teaspoons full/day for phosphorus. I have had regular checks for kidney and other blood work … with no kidney or other issues that I know of. What I have experienced since it has not been available is a serious withdraw … including very high blood pressure and digestive issues.

  8. Tracey Weathers said:

    I have used this product at least five times in the past year because of constant constipation. I have unexplained weight loss and have been unable to make a bowel movement without the use of laxative since. I saw this alert and am now freaking out. I will be following up with my doctor immediately on tomorrow.

  9. Kate Murphy said:

    Fleet Phospho-soda will still be available by prescription from your doctor.

    However, I am more concerned that you have two symptoms of colorectal cancer: unexplained weight loss and a change in bowel habits with serious constipation.

    When you see your doctor ask to have these symptoms evaluated with a colonoscopy. They may well be perfectly benign, but any symptom of colorectal cancer at any age needs to be followed up by a doctor, preferably by a gastroenterologist.

  10. Julie Teuber said:

    I have used Fleet in the small bottle you swallow two small bottles to prep for Colonoscopy. Though I hated the taste atleast it was in a small amount.

    I had to two recently after several years because I was having problems. The first time I used fleet again. Worked both times like a charm and took less time to how should I put this “work it out”.

    The final time I looked everywhere for it and could not find it and was finally told they recalled it. I was prescribed one of those big plastic containers you drink like 10 to 12 glasses of and that made my stomach feel sick. It was terrible.
    It did not work as fast.

    I have had my surgery and have two wait two months to complete the whole process and have part B. Until then there is a bend in the low road so to speak and I need laxatives to help. And normal suppositories and pills do not work to adequately clear everything. I would take the Liquid fleet in a heartbeat. Just to be normal or as close to it until the process gets done. I am only talking about once or twice. Since I now know you can get it prescribed for your doc and I go see mine next week for a post surgery check…I will ask for it.
    Who knew clean pipes that work would mean so much.
    Do whatever you can do Fleet to fix it and bring it back. There isn’t anything like it over the counter. And we won’t talk enema’s. That does not work for a bend in the road.

  11. Billie Williams said:

    I have had many colonoscopies in the past 10yrs and always used this as a prep per my gastroenterologist. I did not have a good PCP til a year ago and he did a 24hr urine. Elevated protein and urine creatinine. Had another in this month and proteins and urine creatinine very high. He sent me back to Nephrologist today and I have Kidney biopsy on Monday. I hope and pray it is not bad as I have dealt with swollen extremities for 6yrs. I had no idea it had been recalled. If my daughter hadn’t told me I wouldn’t have known now. Wish I’d know earlier today.

  12. nancy said:

    For Julie and Billie…Julie for how ever good you think the FPS is, believe me it is not worth the loss of kidney function. Do you have any idea what happens to your body and what you go through if your kidneys fail? Your life is changed instantly from this stuff if it gives you kidney failure. Read about kidney failure and dialysis and all the other diseases you can get when your kidneys don’t work right anymore. FPS has even caused death. Please don’t use this stuff. Billie I wish you the best of luck, I would bet anything you have damage from using FPS. Google kidney failure and FPS. you need to read this stuff, very important, you will see why.

  13. Matt Bolton said:

    I am a stage 4 colon cancer patient. I had to have 14 inches of my colon removed. Due to the redirection of my remaining colon, I have major bathroom issues. Phospho-soda used once a week was the only way for me to exist. My physicians and I tried every softener, diet, fiber, laxative, etc. and only this allows me to pass waste. What am I to do now? I have been miserable since this product was pulled. I know some people have had serious issues, but I need this very badly. Please bring this back with a black box, by prescription, in some form – and quickly!

  14. Kate Murphy said:

    I have contacted Fleet medical affairs and found out that Fleet Phospho-soda is not available by prescription right now.

    It is not on the market and CB Fleet does not know “if or when the product will be made available in the future at this time.”

    I suggest you discuss a different laxative with your doctor. Polyethylene glycol (PEG) laxatives that don’t contain sodium are now available both by prescription and over-the-counter. They work in a similar way to the saline laxatives by drawing water into the bowel.

    More information about a PEG-based laxative

    Talk over this possible solution to your problems with your doctor.

  15. Donna P said:

    I had my fist colonoscopy in May 2008, This year for my physical, when the nurse phoned with blood results I was told my creatnine level was high and need to schedule an appointment with the Advanced renal care center. I am only 53, I cannot believe this could be happening. The only reason I used the Fleets is because the Dr. performing the colonoscopy told me to get that for ‘prep’. Now I’m thinking he told me everything looked good-come back in ten years! NOT LIKELY!

*

*


seven + 6 =

Top