Fleet Phospho-Soda Recalled

Ruzanna Harutyunyan's picture
Advertisement

An over the counter drug used to cleanse the bowel before colonoscopy was recalled last week because of serious side effects including destruction of the kidneys. The product, Fleet Phospho-Soda, made by C.B. Fleet, Co., of Virginia, is involved in product liability lawsuits around the country. The law firm of Rheingold, Valet, Rheingold, Shkolnik & McCartney, LLP, has filed suit on behalf of a number of patients with kidney damage who used Fleet's product.

Fleet's recall followed the release of a Safety Alert by the Food and Drug Administration on Thursday warning consumers not to use over-the-counter laxatives, including Fleet's, in preparation for a colonoscopy due to the risk of kidney damage. The FDA will also now require prescription bowel cleansers, such as Visicol, to carry a black box warning about the risk of kidney damage. Since Fleet's is not a prescription product, it could not comply with the new FDA requirements, thus leading to the recall.

Advertisement

The lawsuits against Fleet allege that it improperly marketed Phospho-Soda at higher dosages than permitted by the FDA for over-the-counter oral laxatives containing sodium phosphate. "The FDA regulations are clear about the maximum daily dosage for these products, but Fleet continued for many years up until this recall to advise doctors and consumers to use twice the daily amount of its product that was permitted by the FDA," said Thomas P. Valet of the Rheingold, Valet law firm.

The safety of the higher dosages has never been demonstrated, according to Valet, who said that the higher dosage leads to deposits of calcium and phosphate in the kidneys, a condition known as nephrocalcinosis. In most cases, damage to the kidneys is permanent, requiring dialysis or even a transplant. The risk of kidney damage is increased in certain patients, according to Valet, including patients taking certain blood pressure medications or diuretics, and the risk of kidney damage increases with a patient's age. Valet said, however, that even those without a pre-existing risk factor can develop kidney failure after using Fleet's.

The link between kidney damage and Fleet's was first reported by a group of doctors in New York in 2003. Valet said that doctors from this group are working with his firm on behalf of injured patients and have been invaluable in helping prepare the cases against Fleet.

Advertisement

Comments

I'm very upset by this --- my doctors prescribed this way back in Nov/Dec and they didn't even have the decency to tell me about this recall???? I'm due for a colonoscopy in 2 days and I'm supposed to take this stuff tomorrow. What a way to find out now!!! Doctors need to be forced to look into things before they jump into giving their patients stuff that isn't good for them! I'm angry! Oh well! Thank the Lord that I didn't take anything yet! -- Upset person in PA --
I agree doctors should inform us, after all we trusted them to better our health. My doctor gave me the appointment for Sat. 1/10/09 back in Nov. and he has not contact me about the recall. I just find out five minutes ago online by chance only because I couldn't find Phospho Soda in the drug stores for purchase. Good that I couldn't get it and found out it's dangerous. Bad that I might have to take the gallon liquid horror. This is my first time and already a bad start. Have to call doc tomorrow & hear what he'll say about plan B. Hope everything go smoothly!!
I have had four scopes done in NY. I became more ill every scope. I made my doctor aware on my very first visit that I had MSK, which is a rare kidney condition, HE STILL HAD ME DRINK THIS STUFF!!!!! My last scope I became so ill he almost sent me to the emergency room!!!! I thought I was going to die!! I was diagnosed with Carcinoid of the rectum two years ago. I missed my last scope, in which I have always maintained, due to the fact that the same doctor wanted me to drink this stuff again!!!! NEVER!! I will die of cancer first. Funny thing, tonight when my medical doctor questioned why I did not keep up on my scopes, I told him what happened, he was OUTRAGED!! He stated I should have NEVER been directed to drink the Fleet to begin with due to my kidney issues!! He wrote down the name of what I should have, and I thought I would share it so anyone who reads this so they can ask their doctor about this product in place of the Fleet it is called GOLYTELY!!!! APPEARS WE MUST BE BEWARE OF OUR DOCTORS!!! I knew their was a problem with this Fleet!! I have been in the hospital for my kidneys five time since my last scope!!!!