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.
Oh, no. What will Al Gore's mother-in-law do now?
My 2 golden retrievers got the injection 2 months ago. I didn't notice any side effects. It scared me when I heard the drug was recalled.
Thanks for the heads up. We've got five furkids who all rec'd this shot three times now. We've had no problems, but this makes me worry about the long term. Guess we'll be switching back to Heart Guard chewables again.
I bet my vet's phone will be ringing off the wall this week.
Is there a doggie ping list? If there is, could I please be put on it?
You make a good point. We intend to take him back to his vet before giving him anything more.
And 'lethargic Jack Russel' is indeed an oxymoron. He can totally wear me down throwing a frisbee for him to catch.
I hope not, too.
She's the only thing that kept me from cracking up when my beloved old dog passed away in in 2002.
I sincerely hope your dog will be okay, as well.
If there's a dog health ping list, I'd love to be added to it.
The FDA has to approve food additives and drugs used for farm animals that get into our food supply. The active ingredient in ProHart6, moxidectin, was already approved for use in beef and dairy cattle to kill intestinal roundworms. Heartworm is a type of roundworm. Your pet's heartworm meds will also kill intestinal roundworms.
Once the initial research and regulatory work to approve a drug has already been done for farm animals, then it's almost a freebie for the FDA to regulate it for pets. Only in this case, someone screwed up on testing it on a different species.
Also, some breeds of dogs are sensitive to certain heartworm meds. For example, collies, Shetland sheepdogs, and similar breeds are sensitive to a heartworm med called ivermectin. Within a breed, some individual dogs are more sensitive than others.
I don't know if the moxidectin problem is limited to certain breeds.
I had a girlfriend write me tonight, very distressed. Her dog has been very ill for several years, and they never knew why. It started about 3 mos after his first injection with the medicine.
Here is part of her letter:
I have been giving my dog this injection for 3 years. Ever since he has been getting this injection, his health has been in steady decline. Prior to given him the ProHeart 6, he was in perfect health.
Three years ago (9/01), we started him on this injection. Around November/December 2001, he started losing his balance and tripping over his front paws. Then in February 2002, he had his first major seizure. Then a couple of weeks later, he began to have multiple seizures. Our vet told us he was epileptic.
His seizures have gotten so bad that even Phenobarbital, a medication used to treat epilepsy, doesn't seem to work. We have had to increase his medication to the maximum amount.
On Thursday, he went for his yearly doggy checkup. He was given the injection again. Last nignt, he began to run into walls, seemed very disoriented, and started tripping over his front paws.
Today, when my husband read the paper, there was an article about ProHeart 6 being recalled due to adverse reactions. 500 dogs have died and another 5,552 have had severe reactions to this injection.
My husband went online and began to research this. He found the below reactions to this injections.
Swelling and pain at the site of the injection.
Diahhrea and vomitting
Lethargy and fever
Wobbliness and weakness
Shortness of breath
Erythema multiforme (bodywide disease with a characteristic rash involving the skin and mucous membranes)
Autoimmune hemolytic anemia (destructions of red blood cells)
Seizures and other neurological evens
Our dog has had all of these symptoms, except death. Although, there have been a couple of times we thought we would have to put him down.
Please send this email out and warn those who have dogs. I feel very bad because here I thought I was helping my dog, but I was only making him worse. Our dogs health has gotten worse, he suffers from a neurological condition. It is now going to take 6 months before this injection completely gets out of his system. I hope he can live through this. If I have known about this, he would not have gotten the injection on Thursday. He has severe skin irritation and sores on his legs. He suffers from shortness of breath and keeps us up all night with diahhrea.
Thank heaven for that.
My dogs are *always* inside during mosquito season, except for quick out-and-ins for potty.
I've seen several websites saying that we tend to over-treat our dogs.
As per the vet's recommnendation, they get *no* heartworm pills during winter.
They start them again in the spring after we have our first over-50 degree day.
I have Ibizan Hounds and like all sighthounds, they're sensitive to many things that don't bother other dogs.
For instance, any flea spray or collar is a definite -no-.
Luckily, they are so fastidious that I've never seen a flea on any of them, even after 15 years of owning the breed.
I've not changed from the monthly dose for my four dogs. Glad I didn't now.
You don't mention what kind of dog he is but please send her this:
It's not something only Goldens get.
My elderly Ibizan Hound got the geriatric form ans misdiagnosed repeatedly as being "epilectic".
She eventually died from it, still not properly diagnosed.
Baribituates made it *much* worse as they only made her dizzier.
I only found about this syndrome months after she passed away.
It's worth discussing with her vet.
All my best wishes for her and her pup.
I have a health and science ping list, a New York ping list, a stem cell list, and a politics, military and foreign affairs list for what I believe are really noteworthy articles.
This past Friday, I noticed the article which referenced the recall of Proheart 6 and upon research found a list of possible side effects. We pulled his medical records and traced back to September 2001 being the date he first began to receive the Proheart 6 injections. In retrospect other symptoms had begun to surface before we observed his first seizure.
It could be mere coincidence, but I am greatly troubled by him having experienced all of the side effects as listed. He had an injection the day before the recall and seized the very next night. Another possible coincidence? Maybe, but the possibilities are troubling.
Thank you, Salamander; hopefully all our puppies, aka, heart-thieves, will overcome this problem and enjoy good health for a long long time.
(I'm so sorry for your loss.)
Thank you, Chong.
I often wonder why I keep putting my head up to the gun, as it were, and always get another dog....;)
I think Rudyard Kipling said it best, in one of the most beautiful, truest and heart-wrenching bits of prose ever written:
As silly as some might view it, I will pray for the health of your beloved Tarheel.
I know what it's like to watch a beloved dog suffer mysteriously, with no answers in sight.
I hope you try what the resident vet suggested and contact the maker of the shot.
Perhaps they can offer some kind of medical assistance.
[Although I'd find it hard to speak them with civility, myself]
At this point I'm trying to regain my calm "center of balance" in preparation for calling my vet, tomorrow.
The shot was something he actively pushed.
I'd never heard of it and I -repeatedly- asked about its safety, which he assured me was -great-.
I finally relented and allowed it and now I feel responsible and very guilty for doing so.
"Two lots of the Proheart were recalled in June of this year."
That was around the time that my dog got her shot.
How can I find out which "lot" was used and what I should watch for, in case she has a delayed reaction?
FWIW, I own a Jack Russel that had a reaction to Proheart that was transient. I gave her a steroid and then after six months we went back to heartgard. My personal experience with Proheart made me advise against using Proheart with Jack Russels, Pugs, Boston Terriers and Chihuahuas.I think Proheart is excellent in large breed dogs that are not over 8 years old or debilitated with preexisting disease. Proheart will take some tinkering to make it safer for dogs but after working with the Fort Dodge veterinarians in research and professional support, many of the adverse reactions to moxidectin were new and totally unexpected and after studies on the efficiency of the drug was thoroughly studied.
I really appreciate you taking the time to explain all this and I feel somewhat better knwoing that *if* something was going to happen, if probably already would have.
Peace of mind, regarding my "kids" is priceless.
I'll call tomorrow when his office reopens and ask for the lot information.
Otherwise, this vet is a great guy who is very gentle and understanding of the "special personalities" of Ibizans.
For example, he is the -only- vet whom my older Ibizan bitch does *not* try to bite.
[they are a very "offish/one person" breed and just have this "thing" about people messing with them if it's not their "mom" or "dad"]...;)
Good luck to you tomorrow.
It sounds like you'll be needing it.
[does anyone really listen to what PETA crackpots say anymore?]
Thanks for your reply. No more heartworm shots for Buddy.
I learn a lot on Free Republic.
FReepmail on the way......
So do I.
I never would have heard about this without FR.
[I LOVE this place!]...:)