September 05 at 11:15
ProHeart 6 recalled
WASHINGTON - 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
> 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
> Reports of injuries, deaths
> As of Aug. 4, the drug agency received 5,552 reports of adverse reactions
> after dogs received heartworm shots. About 500 dogs died, though the
> said many deaths were not directly attributable to the product,
> by Fort Dodge Animal Health, based in Overland Park, Kan., a subsidiary of
> the pharmaceutical company Wyeth.
> Some dog deaths were linked convincingly to the heartworm medication,
> prompted the recall, said Stephen F. Sundlof, director of the FDA's Center
> for Veterinary Medicine.
> Dog owners were urged to consult veterinarians about other medications to
> prevent heartworm.
> The agency had already asked Fort Dodge to revise the drug's label and to
> issue notices to veterinarians and dog owners pointing out safety
> associated with the product.
> "Despite all of the things that have been done, we continue to see these
> adverse events at approximately the same rate," Sundlof told reporters
> The problems suffered by dogs include sudden lethargy, uncontrolled
> bleeding, vomiting, diarrhea, heart and liver problems and such nervous
> system abnormalities as seizures.
> Problems affect dogs of all sizes, ages
> "We don't really understand why this product is causing these problems,"
> Sundlof said. "It affects dogs of all sizes and, apparently, dogs of all
> Fort Dodge Animal Health is cooperating with FDA's request for a recall
> has "concerns about how the agency interpreted these complex data," the
> animal health product manufacturer said in a prepared statement. "Based on
> thorough evaluation of FDA's data and consultation with independent
> in veterinary medicine and epidemiology, Fort Dodge Animal Health stands
> behind ProHeart 6."
> The FDA will convene an independent scientific advisory committee to
> the matter.
> Heartworm disease is caused by a parasite transmitted to dogs via mosquito
> bite. Roughly 250,000 dogs develop the potentially fatal ailment per year.
> Fort Dodge Animal Health said it has sold 18 million doses of ProHeart 6
> veterinarians since FDA approval in June 2001.
> URL: http://msnbc.msn.com/id/5908836/