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Old 09-04-2004, 09:39 AM   #1 (permalink)
 
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heartworm shot kills

FDA recalls popular heartworm drug for dogs
Medicine linked to thousands of injuries, deaths

The Associated Press
Updated: 6:25 p.m. ET Sept. 3, 2004

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.

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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.
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Old 09-04-2004, 12:43 PM   #2 (permalink)
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I'd have chewed off an arm before I'd have let my pugs be injected with that. That gave me the heebie jeebies when I first heard about that new little nasty. Good to see it recalled, finally. Too late for a lot of dogs though. Sad.
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Old 09-04-2004, 08:42 PM   #3 (permalink)
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Don't rejoice just yet. It's a still a voluntary recall.
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Old 09-05-2004, 01:26 AM   #4 (permalink)
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It's so sad to hear that when you are doing what you have to do for the safety and well being of your pet you can not trust the drug you are administering! I have been using the heartgaurd plus.. I don't want to be using anything but heartworms you just can't get around. Long story short, for different medical reasons there are times I have missed schedualed dosages..So I would call the vet's and ask, can I still give it it's a week late a month late and know with this last problem with alleigh it was 2 months late! I keep getting a different response as to how long the residual stay's in effects!! SCARY? Moonstar-
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Old 09-05-2004, 08:32 AM   #5 (permalink)
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I'm sure glad I don't use that to heartworm prevention.. Sound to me like it should be recalled totally.. No if ands or buts about it..
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Old 09-05-2004, 08:34 PM   #6 (permalink)
 
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My family lost our Gordan Setter last summer to cancer, we believed it was, in some way, related to the shot, even before all the controverys started.... now this just adds to the suspicion.
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Old 09-06-2004, 10:00 AM   #7 (permalink)
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Good work stardust, thanks for the heads up.



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Old 09-06-2004, 10:45 PM   #8 (permalink)
 
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no problem.. my mom sent me the link and i figured it was the right thing to do to inform people who didnt know. i hope no one else loses their beloved dog to this..
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Old 09-07-2004, 11:36 AM   #9 (permalink)
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I dont use that either. I use PILLS. Just plain old shove down the thorugh pills. To bad about those poor dogs and their owners.
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Old 09-07-2004, 12:23 PM   #10 (permalink)
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Yes, thanks so much stardust. A co-worker of mine uses it and just had one of her little dogs done last week. Her other dogs were due for another shot. I sent her that story and she just called her vet to find out what she can do. You may have saved several dogs lives.
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Old 09-07-2004, 12:58 PM   #11 (permalink)
 
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wonderful! that makes me feel so good. i hope your friend got the message in time
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Old 09-07-2004, 12:59 PM   #12 (permalink)
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Thats great. hope your firends dog is okay afterwards.
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Old 09-07-2004, 01:02 PM   #13 (permalink)
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I do too. She's really really shook up by it. She's been giving her dogs this shot for about 3 years now, she said. All of her dogs (5 of them) are rescues and some have obvious physical and emotional problems. After reading that article, she wonders if that shot is a contributing factor to some of her babies problems. Obviously not all, but it may have made some things worse or created others. I hate it for her.

Thanks for your concern.
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Old 09-07-2004, 01:55 PM   #14 (permalink)
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like i said before i hope her dogs are fine and i hope she can fix the problems
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