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Heartworm Drug Recalled

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Heartworm Drug Recalled

 

http://www.consumeraffairs.com/recalls04/proheart.html

 

 

 

September 5, 2004

A time-released medication used to prevent heartworm in dogs is being

recalled after thousands of dogs suffered adverse reactions, including

sudden lethargy, uncontrolled bleeding, vomiting, diarrhea, heart and liver

problems and seizures.

 

ProHeart 6 is the only product approved by the Food and Drug Administration

to be administered twice a year to treat heartworm in dogs. The product

caused few problems in clincial trials but when after it won FDA approval,

more problems began cropping up. ProHeart 6 is manufactured by Fort Dodge

Animal Health, a subsidiary of Wyeth.

 

As of Aug. 4, the Food and Drug Administration said, it had received 5,552

reports of adverse reactions after dogs received heartworm shots. About 500

dogs died. While not all of the deaths were linked to the drug, the FDA said

there was sufficient evidence of a problem to justify a recall.

 

The active ingredient in the drug, moxidectin, has been administered without

problem to horses and cattle.

 

Fort Dodge sasid it had " concerns about how the agency interpreted these

complex data. " In a prepared statement the company said, " Based on a

thorough evaluation of F.D.A.'s data and consultation with independent

experts in veterinary medicine and epidemiology, Fort Dodge Animal Health

stands behind ProHeart 6. "

 

Dog owners were urged to consult veterinarians about other medications to

prevent heartworm.

 

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