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Heartworm Drug Recalled

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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