COMFORTIS and ivermectin interaction Safety Warning

http://www.fda.gov:80/cvm/CVM_Updates/C ... Safety.htm

June 24, 2008

COMFORTIS® and ivermectin interaction Safety Warning Notification

Today the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) is announcing that it has received reports of adverse reactions in dogs receiving the drug Comfortis® (spinosad) concurrently with high, extra-label doses of the drug ivermectin. The clinical signs of these adverse reactions are consistent with ivermectin toxicity.

Comfortis® (spinosad), manufactured by Elanco Animal Health, a division of Eli Lilly and Company, is a monthly oral, chewable tablet used for the prevention and treatment of flea infestations on dogs. Veterinarians who use high, extra-label doses of ivermectin to treat dogs with non-responsive demodectic mange and other conditions should be aware that some dogs have developed signs of ivermectin toxicity when ivermectin is used concurrently with Comfortis® (spinosad).

CVM and Elanco Animal Health are advising veterinarians that dogs receiving extra-label doses of ivermectin should not receive concurrent treatment with Comfortis® (spinosad).

CVM is working with Elanco Animal Health as they address this issue. Additional information regarding this safety warning can be obtained on the Elanco Animal Health website.

Lilly Companion Animal Health Technical Bulletin: Spinosad and the Extra-Label Use of High Dose Ivermectin for the Treatment of Generalized Demodicosis in Dogs - http://elms.xh1.lilly.com/10788_03_tech_Bulletin.pdf


--------------------------------------------------------------------------------

Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm


Kristine
Respond to this topic here on forum.oes.org  
so I really should send in those cheek swabs that are on my counter for the MDR1 (or whatever) issue.
kerry wrote:
so I really should send in those cheek swabs that are on my counter for the MDR1 (or whatever) issue.


QUICKLY!! If you're going to do it. The price is going up July 1 instead of in September as they originally projected.

Kristine
Mad Dog wrote:
kerry wrote:
so I really should send in those cheek swabs that are on my counter for the MDR1 (or whatever) issue.


QUICKLY!! If you're going to do it. The price is going up July 1 instead of in September as they originally projected.

Kristine


well here is THE question.

should we test for this, does it run in lines, does it make a difference in treatments if we don't? (okay three questions :) )
kerry wrote:
well here is THE question.

should we test for this, does it run in lines, does it make a difference in treatments if we don't? (okay three questions :) )


I'm not sure what you mean by does it run in lines? Can I tell you that so and so has it in their line, but so and so does not? No. It has a simple mode of inheritance. I know it's in at least some European lines, because the dog I bred Mad to is mutant/normal. She's normal/normal, so we're testing all of her kids, because in this case even being mutant/normal leaves you open to some drug sensitivities, but not as severe as mutant/mutant.

I know it's in American lines, BYB and show lines alike, because I know dogs from both groups who have come back with mutant copies of the gene.

Do you test? Hm.

You can opt to just tell your vet: "OES are part of the group of dogs who can have these known drug sensitivities, I don't know the genetic status of mine, but please treat them as if they are mutant/mutant." And then use interceptor instead of ivermectin based products and so on.

How serious is it? I know my vet was concerned about operating on a mutant/mutant dog, but I also know the dog came through just fine.

Bottom line: I don't really know. Until people are regularly testing, we really won't know the frequency in the breed even. Is it a fluke that three dogs close to me - one a European import I bred to, one a CH bitch who belongs a friend, and one a rescue dog from a midwest BYB - all three probably as unrelated to each other as you can get in this breed - came back with one or two copies of the gene? Beats me.

How many dogs die from complications of having these sensitivities? Again, I don't know.

I'm not panicking. But in my case I need to know the status of Mad's puppies. And you just KNOW I can't resist a genetic test :wink:

Kristine
Mad Dog wrote:



I'm not panicking. But in my case I need to know the status of Mad's puppies. And you just KNOW I can't resist a genetic test :wink:

Kristine


LOL - now she tells me!!!
Yes, I am going to go read the directions and swab Chewie tonight!!! He can be my guinea pig........ :lol:
got sheep wrote:
Mad Dog wrote:
I'm not panicking. But in my case I need to know the status of Mad's puppies. And you just KNOW I can't resist a genetic test :wink:

Kristine


LOL - now she tells me!!!
Yes, I am going to go read the directions and swab Chewie tonight!!! He can be my guinea pig........ :lol:


When I sent his mom's sample in, I checked with Amy first. Then I took a deep breath and said, "OK, I can do this" Then I did. Then I looked at it and thought: "I'm going to feel reeeaaaaallly stupid when they call me up asking me where the DNA is". :lol: :lol: :lol: But it worked.

It is important. Knowledge is power. And with this we won't need to do as much testing down the road because many can be cleared by pedigree.

Thanks so much for doing this.

:ghug:

Kristine
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