Skip to comments.Dog Medicine Is Recalled at Request of F.D.A.
Posted on 09/05/2004 6:24:33 PM PDT by neverdem
By THE ASSOCIATED PRESS
WASHINGTON, Sept. 4 (AP) - A time-released medication used to prevent heartworm in millions of dogs was recalled Friday at the request of the Food and Drug Administration after thousands of dogs suffered adverse reactions.
The medication, ProHeart 6, is the only product approved by the agency to be administered twice a year to treat the 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 it was used to treat dogs after receiving federal approval.
As of Aug. 4, the Food and Drug Administration had received 5,552 reports of adverse reactions after dogs received heartworm shots. About 500 dogs died. The agency said many of those deaths were not directly attributable to the medication, but Stephen F. Sundlof, director of the agency's Center for Veterinary Medicine, said some deaths were linked to it convincingly, which prompted the recall.
ProHeart 6 is manufactured by Fort Dodge Animal Health, based in Overland Park, Kan., a subsidiary of the pharmaceutical company Wyeth.
Fort Dodge is cooperating with the agency's request for a recall but has "concerns about how the agency interpreted these complex data," the company said in a prepared statement. "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.
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 drug.
The problems suffered by dogs include sudden lethargy, uncontrolled bleeding, vomiting, diarrhea, heart and liver problems and seizures.
"We don't really understand why this product is causing these problems," Mr. Sundlof said.
Once again our premier watchdog agency does a sterling job. Thanks FDA! You rock!
Look, I'm a dog owner and lover, but is it really the job of the federal government to protect the health and well-being of our pets? Seems like market forces could address this sort of problem without the government's (initially ineffective in this case) input.
We had our Jack Russel terrier innoculated against heart worms about three months ago. He immediately lost his appetite and became lethargic (ominous sign for a Jack Russel). We became mightily concerned about him.
But after about a month of moping around and eating little, he perked up again and now is back to normal.
This is anecdotal only, but my wife and I had concluded that the sudden total loss of appetite almost had to be connected with the heart worm innoculation.
Of course, we will go back to monthly heartworm pills for him in another three months. But we had made that decision before this FDA ruling.
Good question. I would say yes it is.
Medicine (even for animals) has to be regulated and it would be impractical for individual states to do it. I don't see how market forces could address this. Could you elaborate? I only agree that it's the fed gov's job because I can't think of a better alternative. Would be interesting to hear what others have to say.
Does anyone know if this medication is by prescription only, or can it be purchased at your local store?
Now THAT's an oxymoron: "lethargic Jack Russell!"
Read the post above about one injection lasting two years and still going. It might be harmful to go back to monthly pills if the injection is still working. Check with your vet.
From what I have read, the injection ONLY works for six months. It does not continue to work for two years. If a dog didn't get HW two years later, I believe it is due to luck or some sort of natural immunity the dog has to Heartworms--not the injection.
My vet just gave this "new shot" to my 2 year old a couple of months ago.
He said it was a "good thing".
How freaked should I be?!?
The vet checks his blood at his annual physical and he still has antibodies and a shot is not required.
I tend to think that if there were a question about our dog being protected, the vet wouldn't hesitate to WANT to give him another shot at $100+ per.
Our dog is tiny - 7-8 pounds and is 14 years old and still going strong.
As far as I know, only vets can prescribe and adminster this 6 month shot.
My baby had the fast heartbeat too.
It settled down after an hour or so and the vet didn't it was "connected" to the shot.
That's her first and last dose of that stuff.
Our mastiff puppy had it, didn't have any reaction whatever. I guess we'll have to do the monthly thing, though...
The FDA took the job upon themselves. They approved the medicine and like many other medicines they approve it was faulty.
Thanks for the post, ping.
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