Taylors Mom
September 05 at 11:15
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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 > 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 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 agency > said many deaths were not directly attributable to the product, manufactured > 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, which > 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 questions > 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 late > Friday. > > 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 > ages." > > Fort Dodge Animal Health is cooperating with FDA's request for a recall but > has "concerns about how the agency interpreted these complex data," the > animal health product manufacturer said in a prepared statement. "Based on a > thorough evaluation of FDA's data and consultation with independent experts > in veterinary medicine and epidemiology, Fort Dodge Animal Health stands > behind ProHeart 6." > > The FDA will convene an independent scientific advisory committee to review > 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 to > veterinarians since FDA approval in June 2001. > > URL: http://msnbc.msn.com/id/5908836/
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