I believe mousemistrezz might have already posted this FDA article, but here we go:

FDA Order Prohibits Extralabel Use of Phenylbutazone in Certain Dairy Cattle

February 28, 2003

The Food and Drug Administration (FDA) is issuing an order prohibiting the extralabel use of phenylbutazone animal and human drugs in female dairy cattle 20 months of age or older. FDA is issuing this order based on evidence that extralabel use of phenylbutazone in these dairy cattle will likely cause an adverse event in humans. The Agency finds that such extralabel use presents a risk to the public health for the purposes of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA).

AMDUCA amended the Federal Food, Drug, and Cosmetic Act to allow licensed veterinarians to prescribe extralabel uses of approved animal drugs and human drugs in animals. Section 2(a)(4)(D) of the AMDUCA provides that the Agency may prohibit an extralabel drug use in animals if, after affording an opportunity for public comment, the Agency finds that such use presents a risk to the public health.

Phenylbutazone became available for use in humans for the treatment of rheumatoid arthritis and gout in 1949. However, it is no longer approved, and thus not marketed, for any human use in the United States. This is because some patients treated with phenylbutazone have experienced severe toxic reactions, and other effective, less toxic drugs are available to treat the same conditions

Phenylbutazone is known to induce blood dyscrasias, including aplastic anemia, leukopenia, agranulocytosis, thrombocytopenia and deaths. Hypersensitivity reactions of the serum-sickness type have also been reported. In addition, phenylbutazone is a carcinogen, as determined by the National Toxicology Program.

For animals, phenylbutazone is currently approved only for oral and injectable use in dogs and horses. Use in horses is limited to use in horses not intended for food. There are currently no approved uses of phenylbutazone in food-producing animals.

Investigation by FDA and State regulatory counterparts has found phenylbutazone on farms and identified tissue residues in culled dairy cattle. In addition, USDA's Food Safety Inspection Service has reported phenylbutazone residues in culled dairy cattle presented for slaughter for human food throughout the U.S. in the past two calendar years. This evidence indicates that the extralabel use of phenylbutazone in female dairy cattle 20 months of age or older will likely result in the presence, at slaughter, of residues that are toxic to humans, including being carcinogenic, at levels that have not been shown to be safe.

FDA will consider all comments on this order that the Agency receives by April 29, 2003. Written comments should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should include Docket number 03N-0024. The order will become effective May 29, 2003, unless FDA revokes or modifies the order or extends the comment period.

Additional information on this prohibition is contained in the February 28, 2003, Federal Register. Questions about this prohibition may be directed to: Gloria J. Dunnavan, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-1168, e-mail: gdunnava@cvm.fda.gov.

And in case you missed the key phrase (even though I underlined it and put it in boldface type), here it is again:

FOR ANIMALS, PHENYLBUTAZONE IS CURRENTLY APPROVED ONLY FOR ORAL AND INJECTABLE USE IN DOGS AND HORSES. USE IN HORSES IS LIMITED TO USE IN HORSES NOT INTENDED FOR FOOD. THERE ARE CURRENTLY NO APPROVED USES OF PHENYLBUTAZONE IN FOOD-PRODUCING ANIMALS.

Is that clear enough for you? Oh, and since I learned to cite all of my sources, that is from the FDA's website.

Frizzle, trying to reason with some folks is like beating a dead horse, so to speak. They don't want to hear the truth so refuse to accept it.  What part of

"FOR ANIMALS, PHENYLBUTAZONE IS CURRENTLY APPROVED ONLY FOR ORAL AND INJECTABLE USE IN DOGS AND HORSES. USE IN HORSES IS LIMITED TO USE IN HORSES NOT INTENDED FOR FOOD. THERE ARE CURRENTLY NO APPROVED USES OF PHENYLBUTAZONE IN FOOD-PRODUCING ANIMALS." 

don't they understand?  This is straight from the FDA.  Geez.  Sounds to me like they are really arguing with the FDA ruling on the use of bute in food animals.  They think it should be allowed, I guess.  Call me crazy, but I sure don't want to consume a food product contaminated with bute; and knowing what it CAN do to people is reason enough for me.

mousemistresz:

Frizzle, trying to reason with some folks is like beating a dead horse, so to speak. They don't want to hear the truth so refuse to accept it.

I kept asking "WHY?"  Until I found evidence that phenylbutazone was a carcinogen, I assumed it wasn't.  I kept a bit of trust in a system that kept carcinogens out of our food supply and cared to warn us about the dangers of smoking.  The FDA is obviously trying to keep bute out of the food supply but has not given horse or dog owners the information to choose.

Ignorance is bliss.  Happy now?

gypsy fly:

FDA is obviously trying to keep bute out of the food supply but has not given horse or dog owners the information to choose

As most people know, medicines, chemicals, etc. are metabolized differently depending on what species ingests them. That's why people can eat chocolate and be fine, while a dog who ingests it can die.

Obviously, any medicine that we give our animals has potentially negative side effects; we weigh those against the benefits of the medicine. Yes, bute can actually cause inflamation of the gut and should not be given long-term, but it is a great short-term anti-inflamatory drug. I don't feel that the FDA has pulled the wool over our eyes at all. The information is out there for us; it is up to us as horse owners to educate ourselves.

gypsy fly:

Ignorance is bliss.  Happy now?

Uuuuumm....what? This statement infers that I should be happy because I am ignorant of the facts. All evidence to the contrary, sir.

mousemistrezz, maybe you're right. We could present all the well-documented facts in the world and it would not make a bit of difference to this person.

Frizzle, I agree with everything you stated in your last post.  There are some people who will refuse to accept the truth that is right before their eyes, when it doesn't support their position.  In spite of this, I think we both feel compelled to keep presenting the information anyway, we do it to help the horses.  There are many who are seeking the truth for the sake of the horses, and we can't let them or the horses down.  I am glad to have met you through this forum, and many other like-minded individuals who truly have the horses' best interest at heart.  Thanks for all you do toward that end :)  

To ALL the pro horse people posting here:  Thank you so much for your informative comments and for doing an awesome job standing up for the horses  :-)  I have learned a lot from you and will not give up my fight for the humane treatment of horses.  I am always trying to enlighten horse people (and some non-horse people) about what happens to some of America's horses when they are no longer "wanted" or sound.  It is surprising to know just how many people have no clue as to where many of our unwanted horses go.  I realize we cannot bury all the horses we euthanize or who die natural deaths, but in NO WAY do I believe ANY horse deserves to be mistreated or terrorized in a slaughter plant.  As intelligent human beings, we can come up with a solution to the unwanted horse issue; one that doesn't involve the suffering of our horses. 

mousemistresz:

I am glad to have met you through this forum, and many other like-minded individuals who truly have the horses' best interest at heart.  Thanks for all you do toward that end :)  

 

Right back at ya! My favorite quote, which is in my signature, is "Be the change you want to see in the world." I try to live up to that every day; I'm glad to see that you and many others on this forum feel the same way.

Keep fightin' the good fight!

Frizzle:

mousemistrezz, maybe you're right. We could present all the well-documented facts in the world and it would not make a bit of difference to this person.

Did you both know before this discussion that phenylbutazone, aside from it's known side effects, was a carcinogen?  If so then why did you not honestly care to inform us?

The no withdrawal point would have taken a whole different tack had "carcinogen" been brought up and been proven earlier.  I invite you both to discuss the merits of your choice in the Horse Care forum "To bute or not to bute".

To bring this back around to the slaughter question, it is a choice, isn't it?

From the beginning, we argued that horses treated with bute (among many other substances) were not eligible for slaughter, due to chemicals making the meat unfit/unsafe for human consumpton. To quote 982709 on Friday August 28th, "You are quite correct about phenylbutazone.  It is a known carcinogen and causes aplastic anemia (bone marrow suppression). It has no withdrawal period and is banned in cattle and dairy cows (it used to be used to treat mastitis in dairy cows)." See? I knew you weren't carefully reading all of the posts.

gypsy fly:

To bring this back around to the slaughter question, it is a choice, isn't it?

NO, it is not a choice! We have just presented irrefutable evidence that, due to the widespread use of phenylbutazone, US horses are not candidates for human consumption. How much more proof do you need?! You're wrong. Deal with it.

Gypsy fly, you WERE informed, as Frizzle pointed out - you just chose to ignore the information.  Not only is phenylbutazone carcinogenic, it can cause aplastic anemia in some people, which is fatal, along with a host of other health problems.  It was originally developed for use in people to treat rheumatoid arthritis back in the early 50's, but was soon taken off the market for human use due to the side effects.  This is not a joke, this is serious stuff which the pro-slaughter advocates like to make light of or dismiss altogether. 

I will continue to use bute for my horses, if for no other reason than to disqualify them from ever entering the slaughter pipeline.  I urge other like minded horse owners to do the same.   

mousemistresz:

Gypsy fly, you WERE informed, as Frizzle pointed out - you just chose to ignore the information.  Not only is phenylbutazone carcinogenic, it can cause aplastic anemia in some people, which is fatal, along with a host of other health problems.  It was originally developed for use in people to treat rheumatoid arthritis back in the early 50's, but was soon taken off the market for human use due to the side effects.  This is not a joke, this is serious stuff which the pro-slaughter advocates like to make light of or dismiss altogether. 

I will continue to use bute for my horses, if for no other reason than to disqualify them from ever entering the slaughter pipeline.  I urge other like minded horse owners to do the same.   

You had NO EVIDENCE to start with.  The FDA document you refered to was an application for a new drug.  In the many applications I browsed though, it states that the labeling "Not for horses intended for food", exempted the manufacturer from testing it's effect on humans.  It was hardly a definitive document.  So use the one I found instead.

If I had made the statement that bute was carcinogenic based soley on your statement that it had NO WITHDRAWAL, I'd probably had a call from a representative (lawyer) of the manufacturer.

So now that we know it is carcinogenic AND you are determined to use it.  You have crossed a treshold. 

It's the same kind of treshold that goes between euthanasia and slaughter.  One is for the good of the horse, the other is for your benefit.

Welcome to the slaughter camp way of thinking!

You have just made a choice to use it on your horse inspite of it being a carcinogen.  It's cheaper (related to "greed").  Your horse will probably never get cancer, but you do realize that carcinogens accumulate (I should use your own words.)  It can be a very slow death, not very humane in my opinion.

I do respect your choice, like you should respect slaughter as mine.

gypsy fly, mousemistresz had evidence and it has been given to you. How many times do we have to post the information before you believe it? Here it is again from the FDA site. The EU regulations for bute are the same. It is banned for food animals. I posted the document to my website and already gave you the link. You can keep ignoring it and saying there is no evidence but it doesn’t change the fact that bute is a banned substance and any animal that has received bute, at any time, cannot enter the food chain. Period. It is what it is. You may not agree with it but those are the rules.

She has crossed no threshold. It is the anti-horse folks that have crossed the threshold. The information is nothing new but they continued to send toxic horses to slaughter with no concern for the humans consuming the meat. We have warned of this for years and just like your side has been doing for years, you are doing it now. Instead of facing the facts, you try to twist and find a way around the regulations. The vast majority of horse owners give their horses bute. That is a fact – it the aspirin of the equine industry. So instead of working with us on solutions, and facing the fact that the vast majority of horses that go to slaughter will no longer be accepted, you prefer to find a way to keep slaughtering and poising humans. When the plants closed, the anti-horse folks should have started finding a way to reduce the excess horses they produce. Now, the EU is doing it for you.

http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm100265.htm

Phenylbutazone is known to induce blood dyscrasias, including aplastic anemia, leukopenia, agranulocytosis, thrombocytopenia and deaths. Hypersensitivity reactions of the serum-sickness type have also been reported. In addition, phenylbutazone is a carcinogen, as determined by the National Toxicology Program.

For animals, phenylbutazone is currently approved only for oral and injectable use in dogs and horses. Use in horses is limited to horses not intended for food. There are currently no approved uses of phenylbutazone in food-producing animals.

gypsy fly:

You had NO EVIDENCE to start with.  The FDA document you refered to was an application for a new drug.  In the many applications I browsed though, it states that the labeling "Not for horses intended for food", exempted the manufacturer from testing it's effect on humans.  It was hardly a definitive document.  So use the one I found instead.

GF, the article that I posted that finally got your attention was originally posted by mousmistrez on Tuesday, Spetember 1st. I guess you didn't notice the phrase "Phenylbutazone is known to induce blood dyscrasias, including aplastic anemia, leukopenia, agranulocytosis, thrombocytopenia and deaths. Hypersensitivity reactions of the serum-sickness type have also been reported. In addition, phenylbutazone is a carcinogen, as determined by the National Toxicology Program.

For animals, phenylbutazone is currently approved only for oral and injectable use in dogs and horses. Use in horses is limited to horses not intended for food. There are currently no approved uses of phenylbutazone in food-producing animals" because she only put it in blodface type. You finally woke up and realized that we had solid documentation from a reliable source when I reprinted that same article and then took that same wording and put it in boldface type, underlined it, and capitalized the whole thing. So your claim that we "misled" you or "with-held information" is a fallacy. Just because you seem to have zero reading comprehension doesn't mean that we didn't provide the evidence.

Then you claim we should use your "superior" evidence. OK, so let's see what your article has to say about bute, shall we?

II. Phenylbutazone

    Phenylbutazone became available for use in humans for the treatment
of rheumatoid arthritis and gout in 1949 (Ref. 1), but is no longer
approved, and thus not marketed, for any human use in the United
States. This is because some patients treated with phenylbutazone have
experienced severe toxic reactions, and other effective, less toxic
drugs are available to treat the same conditions (Refs. 1 and 2).
    Phenylbutazone is known for its ulcerogenic, nephrotoxic, and
hemotoxic effects in horses, dogs, rats, and humans (Refs. 2, 4, 5, 6,
7, and 8). It is known to induce blood dyscrasias, including aplastic
anemia, leukopenia, agranulocytosis, thrombocytopenia, and deaths
(Refs. 7 and 8). The reported adverse reactions were associated with
the human clinical use of 200 to 800 milligrams phenylbutazone per day
(Refs. 7 and 8). Hypersensitivity reactions of the serum-sickness type
have also been reported in patients with phenylbutazone. The threshold
for this effect has not been defined. Therefore, it is unclear what
level of exposure would be required to trigger such reactions in
sensitive people. Moreover, phenylbutazone is a carcinogen, as
determined by the National Toxicology Program (NTP) based on positive
results in genotoxicity tests and some evidence of carcinogenicity seen
in the rat and mouse in carcinogenicity bioassays NTP conducted (Ref.
3).
    For animals, phenylbutazone is currently approved only for oral and
injectable use in dogs and horses. Use in horses is limited to use in
horses not intended for food. There are currently no approved uses of
phenylbutazone in food-producing animals.

Hhhmmmm, some of that wording seems awfully familiar...yeah, I can see why you would think that your FDA article is superior to the one we found (and, since you seem to miss a lot, that was sarcasm).

gypsy fly:

So now that we know it is carcinogenic AND you are determined to use it.  You have crossed a treshold

Your lack of comprehension ASTOUNDS me. Do you know how many things we come into contact with every day that are carcinogens? Yes, saccharin has been shown to cause cancer in rats when they are force-fed huge amounts of it every day; does that mean I'm not going to put a few packets in my iced tea? No, because I have the brainpower to comprehend that the levels I ingest are nowhere near high enough to cause cancer. (And, since you like to shout about having a high IQ as if it's some sort of proof that you're right, let me take a moment to say that my father is a cancer research scientist who is respected worldwide; I have discussed these matters with him at length.) Just because something is potentially carcinogenic doesn't mean that it should always be avoided at all costs.

I also know (as I have stated before) that different animal species' systems metabolize medications and chemicals in different ways. Yes, people should not take bute because it can have potentially fatal side-effects. And, while horses can experience some adverse side effects, it is obviously not as big of a risk as it is with humans. I have seen HUNDREDS of horses given bute in my lifetime, and none of them had ANY adverse reactions. That's not to say that it will never happen; it's saying that the chances of a horse having an adverse reaction to bute are not high enough to discount its use.

Yes, bute can have adverse side effects. EVERY medication can have adverse side effects, some of them potentially deadly. Have you ever taken a prescription medication? Take a minute to read the warning label and there will be a laundry list of terrible things that might happen to you. Again, even among the same species, people can have different reactions to medications and chemicals. And, even if there is a .0001% chance of a medication causing adverse side effects, they have to put that warning in with the medication. That is why (as I have said before...I really do not think that you read) WE MUST WEIGH THE POTENTIAL ADVERSE SIDE EFFECTS OF ANY MEDICATION OR SUPPLEMENT WITH THE POTENTIAL BENEFITS.

Your claim that horse owners giving their horses bute is equivalent to sending them to slaughter is completely out of line. Your reasoning is skewed and fallacious, to say the least. I will say, you are skilled at sophistry - but that is definitely not a compliment.

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