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Offline DL

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Banamine (AKA flunixin meglamine)
« on: August 07, 2009, 10:33:06 AM »
Before you get your knickers in a knot please read the whole thing - the reason for these questions is that if the hypothesis is correct the collective anonymous data can be used to describe how beef producers really used the drug and to encourage the bovine practitioners to not push for this change

Please read the label for Banamine, the "official notice" we received the other day and then read and respond to my post :)

"For intravenous or intramuscular use in horses, and intravenous use in beef and dairy cattle.....cattle:...indicated for the control of pyrexia associated with BRD, endotoxemia and acute bovine mastitis...also indicated for the control of inflammation in endotoxemia"


Flunixin Residues and Injection Site Damage
A Serious Problem Requiring Serious Attention by Bovine Veterinarians

1. Flunixin was the second leading violative residue reported in 2007.
According to the USDA Red Book, which reports drug residues found in meat and milk products, in 2007, just under 1% of dairy cows had violative residues (inspector generated sampling), with flunixin being the second most common (number one is penicillin). Flunixin residues were found in 259 cows.
The FDA Center for Veterinary Medicine (CVM) has already warned veterinarians to use flunixin meglumine in the proper and labeled manner. The FDA-CVM states that using a different route of administration for convenience is not adequate reason for extralabel use, making most IM or SC use of flunixin illegal.

2. Flunixin must be given IV.
Withdrawal times are established by a drug manufacturer using the labeled dose, route, frequency and duration. If any of those parameters change, the withdrawal time on the label may not be sufficient. In fact, FARAD has stated that they do not have adequate information to extrapolate a withdrawal time for IM or SC flunixin.

3. Flunixin causes serious tissue damage when given subcutaneously or intramuscularly.
Photographs of the damage caused by flunixin given IM or SC at 14 days post-administration can be found on the AABP website select Members the Member Resources. Even when damage is not visible from the outside of the animal (no lumps or bumps), damage to tissues has occurred, and we can assume that these lesions are painful. In addition to the damage to meat product such as excessive trim, reduced quality, and prolonged absorption of drug leading to violative residues, IM or SC use of flunixin is potentially harmful to the animal. This is an illogical use of a product that is administered to relieve painful and inflammatory conditions.

References
- S.R.R. Haskell, R. Gehring, M.A. Payne, A.L. Craigmill, A.I. Webb, R.E. Baynes, and J.E. Riviere. Update on FARAD food animal drug withholding recommendations. Journal of the American Veterinary Medical Association, 2003; 223(9):1277-1278.
- Food Safety and Inspection Service, 2007 FSIS National Residue Program Data, October, 2008, http://www.fsis.usda.gov/PDF/2007_Red_Book_Complete.pdf, accessed June 23, 2009.
- FDA Veterinarian Newsletter, 2007, Volume XXII, No. II

OK, so we all know that drugs are used extra label in cattle all the time with little or no consequence - they are often used extra label when the health of the beast is not in question (ie most of the synch protocols), again with little or no consequence - in fact it often appears to me that the FDA does not care, unless there is a residue.

From talking to producers, veterinarians, and technicians across the US it appears that in beef cattle Banamine is frequently given either IM or SQ, and that often it is dispensed by the vet for IM or SQ use. It also appears that 4 days is often used as the meat withhold for any or all routes. It also appears to me that beef producers often give it orally - esp to calves.

So I have the following questions (and if you would prefer to not be associated with your answers please email me and I will post the total results)- I am trying to get a sense of it's use in the real world....IMHO this policy is short sighted, not in tune with reality, trying to make residues and injection site lesions a welfare issue, and possible limiting the only approved drug that can be used for bovine pain (although extra label for pain) - your thoughts and responses would be appreciated. I would request one response per farm/ranch and responses from adults only (sorry kids :(

1. Do you use Banamine?
2. If yes, what route do you use?
3. What meat withhold do you use?
4. What is your primary use for Banamine?
5. If extra label use of Banamine was forbidden would you have the facilities and skill to give the drug IV?
6. characterize your operation (registered, commercial, feedyard, club calves, grass fed etc..<100 cows, 100 to 500, >500 etc)
7. any comments?

If the issue is really residues then why not provide reasonable withhold times and make them easily accessible? It is nearly impossible to obtain a reasonable withdrawal for the IM or SQ use of Banamine apparently because they (whoever they are) are pushing very hard to seriously discourage any use other than IV.


TIA for your input and consideration - Dusty remember we are only talking about use in cattle :D
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Offline chambero

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Re: Banamine (AKA flunixin meglamine)
« Reply #1 on: August 07, 2009, 10:46:53 AM »
1. Do you use Banamine? Yes - most commonly in young calves (< six months old) that develop respiratory problems.  We most often give it in conjunction with an antiobiotic.
2. If yes, what route do you use?  Almost always IM in the neck, with a 1.0 or 1.5 inch needle. 
3. What meat withhold do you use?  Since we are using in young calves, these animals aren't headed to slaughter for at least a year.  As a personal policy to avoid residue issues, we don't send any animals to a sale barn that have had any kind of medication in the past 30 days (applies to old cows, etc).
4. What is your primary use for Banamine? Cattle-equivalent of ibuprofen/tylenol.  We'll use it for short-term relief to make a calf feel better while waiting for antibiotics to kick in.
5. If extra label use of Banamine was forbidden would you have the facilities and skill to give the drug IV?  Depends.  When roping and doctoring sick calves in the pasture - no.  This applies to most of the ranchers in my area that run lots of yearlings.  Sick calves are roped and doctored in the pasture.  IV almost impossible with the labor available and lack of facilities.
6. characterize your operation (registered, commercial, feedyard, club calves, grass fed etc..<100 cows, 100 to 500, >500 etc)  Commercial, 100 to 500.
7. any comments?  This drug is so important that effort should be put into establishing a withdrawal period for IM use.  Also specify a requirements that BQA procedures be used.  IM use in the neck isn't hurting carcass quality.  We would be much better off a with a long withdrawal time requirement (30-60 days+) than being forbidden to use the drug IM.


Offline SWMO

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Re: Banamine (AKA flunixin meglamine)
« Reply #2 on: August 07, 2009, 11:01:07 AM »
This study is siting Dairy Cattle does it also involve beef cattle?  It seems most of the reside problems associated with the meat industry are not coming out of the beef cattle industry.

Offline oakview

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Re: Banamine (AKA flunixin meglamine)
« Reply #3 on: August 07, 2009, 11:05:22 AM »
My responses would be exactly as the previous ones exept that I would not feel comfortable with the IV route and we have a 50 cow registered herd.

Offline DL

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Re: Banamine (AKA flunixin meglamine)
« Reply #4 on: August 07, 2009, 11:06:34 AM »
This study is siting Dairy Cattle does it also involve beef cattle?  It seems most of the reside problems associated with the meat industry are not coming out of the beef cattle industry.

Yes these were residues in dairy cattle but if there is a change it would apply to all cattle...we can be proactive or sit on our duff...
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Offline shorthorngirl2010

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Re: Banamine (AKA flunixin meglamine)
« Reply #5 on: August 07, 2009, 11:18:18 AM »
1. Do you use Banamine?
  -Yes, typically in young calves BEFORE taken to summer grass that develop respiratory or navel infection.  Mind you, when we do administer Banamine, it is given with an antibiotic.

2. If yes, what route do you use?
  -IM in the neck (BQA reg's) 18 X 5/8 or 16 X 5/8

3. What meat withhold do you use?
  -Typically dont' have to worry about that, as it is given to calves.  In a 'worst case scenario', if it is given to an animal prior to selling, we normally go 30+ days withold.

4. What is your primary use for Banamine?
  -Pain relief/ Anti-Inflammatory

5. If extra label use of Banamine was forbidden would you have the facilities and skill to give the drug IV?
  -Yes, I do have the skill, but when doctoring calves in the pasture, the facilities would not be available.  

6. characterize your operation (registered, commercial, feedyard, club calves, grass fed etc..<100 cows, 100 to 500, >500 etc)
  -Commercial, >500

7. any comments?
  -As often as this drug is administered, I feel that an IM withdrawl time needs to be established, as not everybody has the skills to administer an IV injection.  Also, if they DO have the skills, time or facilities may be a factor that plays into the resulting SubQ or IM injection.  Furthermore, if the drug is administered according to BQA regulations [any IM injection is to be administered IN FRONT of the point of shoulder], one need not worry about lesions in your higher quality cuts, as injections should be in the neck region.  
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Offline kanshow

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Re: Banamine (AKA flunixin meglamine)
« Reply #6 on: August 07, 2009, 11:32:08 AM »
Insert Quote
1. Do you use Banamine?
Yes, typical use is in little calves or cows during calving season.

2. If yes, what route do you use?
  -IM in the neck

3. What meat withhold do you use?
We've never used it in cattle that are close to going to sale or market.  If that were the case, I would estimate at least a 30 day withdrawal??

4. What is your primary use for Banamine?
  -Pain relief/ Anti-Inflammatory

5. If extra label use of Banamine was forbidden would you have the facilities and skill to give the drug IV?
  To echo a previous poster, yes I have the skill and if the animal is at home then facilities are available.  Otherwise, there are many cases were the limiting factor will be facilities.

6. characterize your operation (registered, commercial, feedyard, club calves, grass fed etc..<100 cows, 100 to 500, >500 etc)
Small registered <50, commercial 100-500, and backgrounding lot.

7. any comments?
I agree with the previous statements, an effort should be made to get a label withdrawal time and BQA of IM or SQ in the neck.   This drug is a very effective and important drug in certain cases.   

Offline SWMO

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Re: Banamine (AKA flunixin meglamine)
« Reply #7 on: August 07, 2009, 11:51:29 AM »
1.) Yes  typically in small calves and calving issues
2.)IM
3.)Never used in cattle going straight to market.
4.)Pain relief and Anti-Inflammatory
5.)Facilities are always a limiting factor and would have to take a lesson or two on IV but would be comfortable doing it.
6.)registered and commercial >= 50 head.

Have used recently on a fall born heifer that was apparently ridden too much while bulling and would not lay down.  Agree with other posters that this is an important drug for livestock producers.

Offline OH Breeder

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Re: Banamine (AKA flunixin meglamine)
« Reply #8 on: August 07, 2009, 12:57:18 PM »
Less than 50 cows here.

Given in conjection with other medicatoins for infection or injury. We keep most meat for family use only. We use it as short term pain relief and andtipyretic.

If you can administer the drug directly in the vein then yes, I would adminstier IV and have when directed by vet. If it has to be diluted and infused that would be a bit more difficult. I am assuming you mean direct injection into the vein.
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Offline Dusty

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Re: Banamine (AKA flunixin meglamine)
« Reply #9 on: August 07, 2009, 01:10:46 PM »
1. Do you use Banamine?
     Yes

2. If yes, what route do you use?
     Orally... Or try to hit a vein in the tail.

3. What meat withhold do you use?
    4 days

4. What is your primary use for Banamine?
       Painkiller

5. If extra label use of Banamine was forbidden would you have the facilities and skill to give the drug IV?
    Yeah.

6. characterize your operation (registered, commercial, feedyard, club calves, grass fed etc..<100 cows, 100 to 500, >500 etc)
     Mainly club calves with a few cows.

7. any comments?
    Banamine will definetly get rid of a hangover!!!   But DO NOT take it and then start drinking right away.
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Offline DLD

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Re: Banamine (AKA flunixin meglamine)
« Reply #10 on: August 08, 2009, 12:08:33 AM »
1. Do you use Banamine?   Yes

2. If yes, what route do you use?   IV if possible (if we can get them to a chute), if not IM in the neck

3. What meat withhold do you use?   Wouldn't slaughter for at least 30 days, as others have said that's really not an issue since we use it almost exclusively in calves

4. What is your primary use for Banamine?  Pain relief/anti-inflammatory.  It really seems to be a big help to those little ones in respiratory distress.

5. If extra label use of Banamine was forbidden would you have the facilities and skill to give the drug IV?
Yes.

6. characterize your operation (registered, commercial, feedyard, club calves, grass fed etc..<100 cows, 100 to 500, >500 etc)  Club calf/commercial, 100 to 500 head.

7. any comments?  I agree that it would be great if it were approved for IM or SQ use.  So many producers rely on it in doctoring young calves where there just isn't enough help and/or facilities to use it IV.
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Offline DL

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Re: Banamine (AKA flunixin meglamine)
« Reply #11 on: August 09, 2009, 08:05:32 PM »
Thanks to everyone who has replied and provided information about their use of Banamine in beef cattle. This has become a rather hot and interesting topic on the bovine vet list and I was hoping to have a large number of responses to use as ammunition to push for establishment of withdrawals for IM and SQ and oral use.

All you guys out there who pi** and moan when I talk about illegal use of drugs - this is you chance to provide information that could be used to promote change of the rules or promote the approval of other drugs for pain management in cattle. The rules and regs in the US are different from Canada, the EU, Oz and NZ -

cowboy, juli, jill, norma, tony, old goat, etc your input on this topic - either as a post or an email - would be greatly appreciated - thanks
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Offline Jill

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Re: Banamine (AKA flunixin meglamine)
« Reply #12 on: August 09, 2009, 09:46:20 PM »
Sorry, I've been at the county fair and just saw this post.
1. Yes
2. IM in the neck
3. In calves not really an issue, in calving or pain issues, a 30 day.  As a side note, when we had Bramie at K-State she came home after this type of injection with 30 day withdraw instructions for butcher so I would "assume" that would be a safe withdraw period.
4. We use it in conjunction with Nuflor/Baytril type of drugs to calm respitory problems, as an anti-inflamitory for calving issues, c-sections etc.
5. I do not feel we have the skill or desire to do an IV, that would be a vet call.
6. Registered/Club calf herd-50 head.
7. I have to agree with most of the other posts here, I do not see a need to ban an IM use of a drug when the primary injection site seems to be in the neck, the study sites a 14 day site and I guess in my opinion tissue damage to the neck would be better than a dead calf.  I guess I don't really see Banamine residue in 259 cows over a period of a years time being a major issue, I don't see anywhere in the study that Banamine residue would be harmful if injested by humans, I guess I could see milk residue being a bigger issue than meat residue would be. 
I guess I really would have to question this being a welfare issue as I know in our operation the reason we use banamine is for the relief of pain, not to cause it, and it does visably relieve the pain and calms the calf/cow.
I believe that many drugs are used extra label and don't have the necessary testing done to establish a withdraw simply because of the ungodly cost involved in getting FDA approval, I do however think the number and need of applications this is used in would justify a withdraw for IM use being established for this drug.  I can't speak for everyone, but  I know this is a staple at our house, there isn't a winter that goes by that we don't use this.

Offline Cowboy

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Re: Banamine (AKA flunixin meglamine)
« Reply #13 on: August 09, 2009, 10:51:45 PM »

1. Do you use Banamine?  Yes

2. If yes, what route do you use? Although I prefer an IV route and almost always get that done, I am guilty of the occasional IM route. SQ behind the front leg is another route used on rare occasion -- this will 99% prevent any lumps or visible tissue disruption for the club calf industry as well, however I don't belive it is as efficasious as IM or IV

3. What meat withhold do you use? Have never sent an animal to auction or had one butchered with Banamine insystem for less than 60 days.

4. What is your primary use for Banamine? Both for Equine and Bovine as a pain reduction avenue. Seems to reduce swelling to some degree as well, but you need to watch for that as it is subtle.

5. If extra label use of Banamine was forbidden would you have the facilities and skill to give the drug IV?
Absolutely --

6. characterize your operation (registered, commercial, feedyard, club calves, grass fed etc..<100 cows, 100 to 500, >500 etc) Club calve less than 100, Full time commercial ET center (Some times busy - some times not so much)

7. any comments? Banaamine most likely has been abused in the sense that it has and will continue to be given in any convenient place you can reach with a syringe. We have to face the facts, alot of places just do not have the luxury of being owner operators -- there are times when the help will step up to the plate and do what is written on the wall for this or that. It happens, shots are given of the wrong drug and combination of those drugs -- at least a few times making the symptoms WORSE instead of better. Most of the time, people are up to snuff as to what it does. I'd like to see alot of drugs today come with labeling that tells which drugs get along with others, and which ones do not get along at all. IE --Penn and Tetracyclenes work indifferent modes, one goes directly to the source of infection - the other works on the system to ward off infection. Used together -- there are times they would tend to counteract each other. Seen it happen. DL can further relateto that syndrome.

Bottom line, Banamine is a valuable drug for alot times -- used correctly and timely it is priceless.

I do use it sparingly however -- only when needed to help get something thru the day!

Terry

Cows are family too -- we treat em like they are !!

Offline DL

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Re: Banamine (AKA flunixin meglamine)
« Reply #14 on: August 10, 2009, 07:42:16 PM »
Thanks Jill & Terry - still waiting on others to step up to the plate - here is your opportunity to have a positive impact on how we manage pain in beef cattle....
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