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FDA Centennial


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


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