Dog Medicine Is Recalled at Request of F.D.A.

NY Times ^ | September 5, 2004 | NA

[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.

[Savage Rider]

Oh, no. What will Al Gore's mother-in-law do now?

[Merry]

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.

[NicNacPattyWac]

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?

[Ole Okie]

It might be harmful to go back to monthly pills if the injection is still working.

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.

[Salamander]

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.

[LibFreeOrDie]

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 still care]

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.
Facial swelling
Diahhrea and vomitting
Lethargy and fever
Wobbliness and weakness
Rash
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
Death

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.

[Salamander]

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.

[Salamander]

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.

[blam]

"Our mastiff puppy had it, didn't have any reaction whatever. I guess we'll have to do the monthly thing, though..."

I've not changed from the monthly dose for my four dogs. Glad I didn't now.

[Salamander]

You don't mention what kind of dog he is but please send her this:
http://www.vetinfo4dogs.com/dvestib.html
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.

[neverdem]

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.

[cyborg]

vet ping

[vetvetdoug]

Yes, I am aware of this and have worked closely with Ft. Dodge veterinarians since I thought I had a dog with a reaction (Come to find out the dog had lepto and an intestinal obstruction and no symptoms due to the Proheart). Two lots of the Proheart were recalled in June of this year. Luckily, we followed the label recommendations and gave it to only large breed dogs and dogs over 20 pounds and only dogs under 8 years old. Any dog that was debilitated or looked like it might have a reaction (that is where art and medicine come together) was not given the Proheart and sent out with Heartgard or Interceptor. Some of the Internet stories about Proheart are bogus and of questionable veracity. Like any medication, Proheart went through extensive testing before it was marketed. I foresee that it will return but will have multiple precautions and will be used sparingly and with client's very advised consent.

[evangmlw]

I am the owner of Tarheel, a 140lb German Shepherd who is the dog spoken of by I Still Care. The first five years of his life, we had no health problems with him. In February of 2002, he began to have seizures and was diagnosed as being epileptic, at which time he was placed on Phenobarb to subdue seizures.

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.

[Chong]

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.)

[vetvetdoug]

If your dog has these reactions and your veterinarian had suspected it was such, a phone call to Ft. Dodge would have helped. Fort Dodge has done everything they can to prove or disprove a reaction from the Proheart injection. In one particular case where I thought I had a Proheart reaction, Fort Dodge Animal Health paid for all of the diagnostics necessary to find the root of the dog's problem. The veterinarians gave me carte blanche in diagnostic support and Fort Dodge's Proheart was exonerated. Fort Dodge's technical support veterinarians were very helpful in getting to the root of a problem. If I were to be asked if Proheart is safe, I would have to say yes IMHO if used with the precautions stated on the label. As with all medications, one has to weigh the positive outcomes with the negatives. Heartworms are a real problem, Heartgard is safe and so is Interceptor but only if the owner gives it monthly. If an owner doesn't give the heartworm prevention on schedule then Proheart is the best way.

[Salamander]

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:

---

"The Power of the Dog"

There is sorrow enough in the natural way
From men and women to fill our day;
And when we are certain of sorrow in store,
Why do we always arrange for more?
Brothers and Sisters, I bid you beware
Of giving your heart to a dog to tear.

Buy a pup and your money will buy
Love unflinching that cannot lie --
Perfect passion and worship fed
By a kick in the ribs or a pat on the head.
Nevertheless it is hardly fair
To risk your heart for a dog to tear.

When the fourteen years which Nature permits
Are closing in asthma, or tumour, or fits,
And the vet's unspoken prescription runs
To lethal chambers or loaded guns,
Then you will find -- it's your own affair --
But . . . you've given your heart to a dog to tear.

When the body that lived at your single will,
With its whimper of welcome, is stilled (how still!)
When the spirit hat answered your every mood
Is gone -- wherever it goes -- for good,
You will discover how much you care,
And will give your heart to a dog to tear.

We've sorrow enough in the natural way,
When it comes to burying Christian clay.
Our loves are not given, but only lent,
At compound interest of cent per cent.
Though it is not always the case, I believe,
That the longer we've kept'em, the more do we grieve;

For, when debts are payable, right or wrong,
A short-time loan is as bad as a long --
So why in -- Heaven (before we are there)
Should we give our hearts to a dog to tear?

---

For myself, I can't help but do it.
My home and my life seem so empty without dogs.
I've always had at least one and I suppose I'm spoiled now....:)

[Salamander]

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.

[Salamander]

"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?