Question on Extra-label

[apj101]

Hello everyone,
I have a quick question which Im sure someone here can answer.

Roughly......i only need roughly
what is the number of licensed veterinary drugs available vs the total number of human drugs that are typically prescribed extra-label

So for example if there are typically X number of drugs currently being used on animals (i know technically it could be any number of drugs, but lets just say typically, as in how many are commonly used) then how many of those X drugs are actually licenced for veterinary use and how many are human drugs
just rough numbers, unfortuantly % are no use to me 🙁


REALLY APPRECIATE any help you may have...here I'll spread some love 😍

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[WhtsThFrequency]

I'm a little confused. The number of veterinary drugs used extra label versus the number of human drugs use extra label? Or the number of human drugs used extra label in animals? The latter I have no idea about because usually for medications used in humans there is a seperate licensed (albeit mostly identical) drug for animals (ie aspirin, antibiotics....same compound, different name/concentrations/etc).

You would have to ask human doctors about human medications. I have no idea how many human medications/drugs there are, or how they are used.

TONS and TONS of veterinary drugs are used extralabel....usually drugs approved for one or two species but are used in several....it's an essential part of the industry because of the number of species. Practically every veterinary drug in existence has been or can be used extralabel, given the proper guidelines.

http://cpharm.vetmed.vt.edu/vm8784/default.htm

http://cpharm.vetmed.vt.edu/vm8784/AMDUCA/PrintAmducaCFR.cfm


Go here and look under AMDUCA for more info.

This is the FDA Animal Drug Database also. It's searchable for every approved drug.

http://www.accessdata.fda.gov/scripts/AnimalDrugsAtFDA/

 

[apj101]

TONS and TONS of veterinary drugs are used extralabel....it's an essential part of the industry because of the number of species.

http://cpharm.vetmed.vt.edu/vm8784/default.htm

http://cpharm.vetmed.vt.edu/vm8784/AMDUCA/PrintAmducaCFR.cfm


Go here and look under AMDUCA for more info.

haha yeah that much i know....but what is TONs, i TONS is relative...10 is tons compared to 1 🙂

are we talking hundreds, thousands, tens of thousands, millions?
I though it may be something you guys would have a gut feeling for.

Maybe you know how many drugs have been specifically licenced for veterinary use? that may help

cheers I really appreciate your help

 

[WhtsThFrequency]

Do you mean just generic drugs all (say, acepromazine) or the drug plus the brands/specific formulations (Fort Dodge's brand, Pfizers brand, etc? Or something like "ivermectin" versus the dozens of formulations and routes all for different species?

"approved veterinary drugs" is an extremely board statement. Does this include vaccines?

Do it include the various formulation such as oral ace versus injectable ace?

Generic drugs, in the hundreds by far. Add to the fact that each generic has different versions/different companies that make it (the 4 way respiratory vaccines for cattle, for example, have 6 to 10 brands)....in the high hundreds to low thousands, I would think.

 

[apj101]

Do you mean just generic drugs all (say, acepromazine) or the drug plus the brands/specific formulations (Fort Dodge's brand, Pfizers brand, etc? Or something like "ivermectin" versus the dozens of formulations and routes all for different species?

"approved veterinary drugs" is an extremely board statement. Does this include vaccines?

Do it include the various formulation such as oral ace versus injectable ace?

Generic drugs, in the hundreds by far. Add to the fact that each generic has different versions/different companies that make it (the 4 way respiratory vaccines for cattle, for example, have 6 to 10 brands)....in the high hundreds to low thousands, I would think.

Bugger, this just had to be more complicate than I hoped 🙂

I guess I'm including all the licesned generics as well as branded stuff.
And to be fair I'm really only bothered about the companion market as in small animals rather than livestock, I just thought it would be easier if I lumped them together.
Am I including vaccines?...err...yes I suppose I should.

Cheers for the help!

 

[No Imagination]

Merck Veterinary Manual might be a good place to start. Im sure they have a "Merck Non-Veterinary Manual" for that other species we dont work with - perhaps you can compare to two?

Not quite following what you are looking for either.

if you are industrious, you can find copies of both Merck's in digital form

 

[WhtsThFrequency]

Oh, boy...if you include all vaccines, all drugs and brands...definitely in the thousands.

Off label usage is more common the large animal stuff than small, but occurs in small because there are fewer drugs approved for cats, for example

Few drugs are being used exclusively off label. Most are approved for one species, or route, or whatever, and used off label for others. In food animals, I'd wager that anywhere from 50 to 70% of drugs are being used off label (in addition to their labeled usage, of course), and basically *ANY* drug *can* be used off label, providing you are doing with medical backup and good reasoning.

Vaccines are usually not used too much off label, though, in my experience. Some, yeah, but not nearly as much as medications. I don't know about small animal, I believe it would be less. But I'm just guessing. Sorry I can't answer more specifically...because that would involve basically looking up every drug known to the vetmed world 😱 and...err...I have things do to 😉

I mean seriously...every drug, brand of the drug, route of the drug, every vaccine, formulation, brand?......damn. I can't even begin to imagine the numbers, let alone the real percentages. Antibiotics ALONE would be in the hundreds!

 

[InfiniVet]

I would say that "licensed" (which I'm taking to actually mean FDA approved) veterinary drugs will always be less than FDA approved human drugs.
There's not nearly the need for extra label usage of human medications for treating humans as there is extra label usage of veterinary/human medications for animals.

That help at all?


If we're not talking about FDA approved drugs then its a whole nuther can of worms.
Remember vaccines are USDA regulated...they're not "drugs" 🙂

 

[No Imagination]

So, what exactly does "Extra Label" mean? In veterinary, I know it means for use in species that it wasn't designed, or tested on or for.

I am guessing from your definition (extra label use in humans), it also means for treatment for something that wasn't it's intent?!

Like the use of Viagra to treat ED but now also apparently pulmonary hypertension? So would that mean "Viagra for the treatment of pulmonary hypertension" is Off-Label?

If so, I would think there are TONS of off label drugs out there for Humans - Asprin, acetylsalicylic acid, ibuphrophin, naproxen, all NSAIDS...

 

[Angelo84]

Extra label means that a drug is used at a different dose, by a different route, in a different species, or for a different application than is given on the label. If you change any of those factors you are using the drug "exta label". So if you gave tylenol tablets to a cat it is extra label (you would also kill the cat). If you gave injectable baytil orally it's extra label.

Sorry no idea on the numbers.

 

[chris03333]

double post sorry!

 

[chris03333]

So, what exactly does "Extra Label" mean? In veterinary, I know it means for use in species that it wasn't designed, or tested on or for.
...

Actually extra label in veterinary medicine means used in a species, dose or route that is not listed on the label of the drug (all medications have been tested on a rodent (meaning mouse or rat) and then a "higher species" (like dog, cat, guinea pig, rabbit) before they can go to human trials and you are still hard pressed to find many drugs which are actually labeled for rodents, so you use them "extra label" when you treat a mouse patient, but I can guarantee that they have been tested in those animals. It just cost $$$ to get approval for each species on the label.

Here is a pretty good link explaining:
http://www.peteducation.com/article.cfm?c=0+1303&aid=1412

 

[WhtsThFrequency]

If so, I would think there are TONS of off label drugs out there for Humans - Asprin, acetylsalicylic acid, ibuphrophin, naproxen, all NSAIDS..

Technically that's true, but a lot of those things are OTC, therefore the term "extra label" doesn't *exactly* apply...unless your doc were to prescribe high dose ibuprofen for something other than pain control and the like, then it would be extra label in the full meaning of the word.

You're right with the Viagra though, unless it has been specifically approved for a condition, it is extra label.

 

[VeganSoprano]

Short answer is lots and lots. Off the top of my head, injectable Baytril and Cerenia are both off-label for use in cats, yet are used in cats all the time with great results and minimal adverse effects. These are just two drugs I can think of without looking at any resources whatsoever.

 

[VeganSoprano]

deleting a double post

 

[No Imagination]

Here is a pretty good link explaining:
http://www.peteducation.com/article.cfm?c=0+1303&aid=1412

Thanks for the link. Thanks everyone else as well.

I think I see now where my confusion stems from - i've been using Extra label synonymously with Off Label (I did it in my post without even realizing it)

I see now (I think) that Extra Label is pretty much a veterinary reference/phenomenon, while Off-label (while also Vet related) is more a Human med term.

Extra Label = Cross species (and different route/dose)
Off Label = Use for a different treatment then intended/tested on (and I guess different

I'm sure there is more overlap between the terms but I think I've got the idea -I also think this has confused me before

 

[InfiniVet]

Thanks for the link. Thanks everyone else as well.

I think I see now where my confusion stems from - i've been using Extra label synonymously with Off Label (I did it in my post without even realizing it)

I see now (I think) that Extra Label is pretty much a veterinary reference/phenomenon, while Off-label (while also Vet related) is more a Human med term.

Extra Label = Cross species (and different route/dose)
Off Label = Use for a different treatment then intended/tested on (and I guess different

I'm sure there is more overlap between the terms but I think I've got the idea -I also think this has confused me before

Sorry to confuse you more...but I swear on my B in pharmacology that:
Extra label use means ANY use that is not specifically on the label.
So, extra label = off label.
Species, route, etc doesn't matter. Anything that deviates 1 word from the labeled indication is Extra Label.
The indication is "To treat pneumonia in feedlot calves give 2.2mg/kg oral for 7 days"
Give it to dairy calves? That's a extra label usage. Give it for 8 days? Extra label. Give it IV to humans at 6 mg/kg to treat gonorrhea? Extra label. 🙂

The AMDUCA definition is: "Extralabel (or extra-label) use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions." http://www.fda.gov/cvm/amducatoc.htm

 

[eventualeventer]

Just to make things even more complicated, in veterinary medicine it is not uncommon to have a compounding* pharmacist to give you a drug that a) is not approved for any use in the US, b) is approved but not currently available in any form, or c) is only available by a different route or concentration that is unusable for the current purpose. Some examples:
- Pergolide is being phased out of human medicine due to cardiac side effects in Parkinson's disease patients. I don't think there is an animal form. Pergolide is very commonly used to treat Cushing's disease in horses and is obtained from compounding pharmacies.
- For a while, proprietary powdered bute was not available due to some manufacturing issue. Many people used compounded bute powder until it became available again. Many do still use the compounded form, but it is considered illegal compounding since there is once again a proprietary formulation, according to my former boss, who knows and talks to people in the FDA's CVM.
- I have seen vets use compounded dipyrone for fever in horses and foals; dipyrone was banned for human use in the 1970's.

*This is leaving aside compounding in the sense of flavoring or dissolving pills to make liquid.