ProHeart 6, a twice-a-year time-released heartworm medication used to treat millions of dogs, was recalled Friday at the request of the Food and Drug Administration after thousands of animals suffered adverse reactions.
ProHeart 6 was the first, and only, product approved by the FDA to be administered once every six months to treat heartworm disease in dogs. Its active ingredient, moxidectin, has been administered without problem to horses and cattle.
The time-released version caused few problems when given to dogs at higher doses in clinical trials. Health and safety problems quickly cropped up, however, when ProHeart 6 was used to treat dogs after receiving FDA approval, reports MSNBC News.
Among reactions suffered by dogs: lethargy, uncontrolled bleeding, vomiting, diarrhea and seizures. Some dog deaths were linked convincingly to the heartworm medication, which prompted the recall, said Stephen Sundlof, director of the FDA's Center for Veterinary Medicine. He did not give any specifics.
"It affects dogs of all sizes and, apparently, dogs of all ages," Sundlof said. The drug is manufactured Fort Dodge Animal Health, a subsidiary of the pharmaceutical company Wyeth.
Dog owners were urged to consult veterinarians about other medications to prevent heartworm. The agency has asked Fort Dodge to revise the drug's label and to issue notices to veterinarians and dog owners about safety concerns. The company is cooperating with the recall request. The FDA will convene an independent scientific advisory committee to review the matter.
Heartworm disease is caused by a parasite transmitted to dogs via mosquitoes. Roughly 250,000 dogs develop the ailment every year, informs Detroit Free Press.
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