FDA, Fort Dodge bringing Proheart 6 back on the market
By Christie Keith
June 5, 2008
FDA and Fort Dodge are bringing the heartworm preventive Proheart 6 back on the market after it was voluntarily withdrawn by Fort Dodge after what they called “serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.”
Based on new pharmocological and toxicological studies, as well as experience in foreign markets:
FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.
“This is the first veterinary drug to be marketed under a risk minimization and restricted distribution program. Numerous drugs for use in people have been successfully marketed under similar programs,” said Bernadette Dunham, D.V.M., Ph.D., director, FDA’s Center for Veterinary Medicine. “While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions.”
[....]
The risk minimization and restricted distribution program is intended to educate veterinarians and pet owners regarding the possible risks associated with the use of ProHeart 6. Therefore, Fort Dodge Animal Health is requiring veterinarians who wish to purchase ProHeart 6 to register with the company and participate in a Web-based training program prior to obtaining the product.
There was a teleconference at 2 pm CT that I was unable to attend as I’m in the middle of a new computer installation. I’ll update with new information later this afternoon. Stay tuned.
Vets aren’t even distributing required information when they prescribe NSAIDS. What’s supposed to convince me that they’ll comply with the requirements of a restricted distribution program?
Comment by The OTHER Pat — June 5, 2008 @ 11:43 am
The best way to minimize adverse effects ie seizures or death of the pet, is to just tell your vet that it will be a cold day in hell before you use that crap, then kick the vet, hard, for suggesting it.
Or take the FDA policy approach “when ENOUGH dogs die, the drug will get pulled” (direct quote, by the way) meanwhile profits as usual!
Comment by LoveyHowell — June 5, 2008 @ 12:26 pm
Well, I’m not surprised at all .. you know the old phrase that we’ve heard repeatedly .. “they’re just dogs.”
Kick the FDA too while you’re at it.
Comment by Nadine L. — June 5, 2008 @ 1:01 pm
Comment by The OTHER Pat — June 5, 2008 @ 11:43 am
Pet owners are too stupid to read such things, it is a burning question in the veterinary field how they manage to sign credit card slips.
Fork over the money and shut up is the AVMA motto.
What? Did you expect the health of your pet to matter when there is all that money from pet food and drug sales to be made?
Not bloody likely.
Comment by LoveyHowell — June 5, 2008 @ 1:08 pm
I’m wondering how many pet owners know that there is info they should be getting. Many don’t know to ask, and many also don’t know the right questions to ask their vets about drugs and procedures.
How can they do a risk minimization and restricted distribution program? Have they narrowed down the problems or the dogs most likely to react? Once it’s in the dog . . .
Comment by straybaby — June 5, 2008 @ 2:37 pm
Does anyone know anything about Tri-Heart Plus?
Haven’t given it to my pet yet and wonder if there
have been any serious risks. Any feedback, please.
Comment by VJ — June 6, 2008 @ 4:13 am
Tri-Heart Plus is the lower cost version of Heartgard Plus - right? Same drugs and dosages? I haven’t heard anything negative.
Comment by slt — June 6, 2008 @ 7:32 am
The words ‘Fort Dodge’ are enough to make me say ‘no, thanks’ - as advised by my former vet.
Comment by Caveat — June 6, 2008 @ 9:46 am
We lost a puppy and nearly the whole litter due to a vaccine reaction. The maker Fort Dodge. It can happen with any vaccine, but FD refused to acknowledge even the possibility. We were not the only ones to run into a problem at the time (this was about 12 years ago). My vet and I moved on to another brand, thank you very much.
Comment by JenniferJ — June 6, 2008 @ 10:47 am
Please stay away from the generic heartworm preventions. The ivermectin was recalled about 90 days ago that is used in the generic form due to it not having the amount of drug that it stated that it had. I would only use Heartgard purchased from your vet and not off the internet. (who knows where that stuff comes from. )
Comment by Lily — June 6, 2008 @ 2:53 pm
I think we need to understand that proheart is niche product! It has been stated the #1 issue with heartworm drugs, is the fact people forget to give them. This makes a disease, that is 100% preventable, prevalent & ever so increasing.. Proheart addresses those people! Also, keep in mind that a 12 month version of this product is in multiple foreign countries.
My point is if people were responsible and gave the pills we would not be having this discussion!!
Comment by JJ — June 7, 2008 @ 1:48 am
So you’re arguing that for those people who forget a monthly pill, they should sign a form that says that if Proheart 6 kills their dog, they were informed of the possibility and so too bad, so sad?
Check out the take the Terrierman has on this product and its reappearance. Provocative, to say the least.
Comment by Gina Spadafori — June 7, 2008 @ 5:39 am
Also, keep in mind that a 12 month version of this product is in multiple foreign countries.
Yes… it’s a DIFFERENT PRODUCT. There has been much speculation that the microencapsulation thta makes it a 12 vs a 6 month product is the very reason there were so many problems with the drug in this country.
But by all means let’s find out on our pets.
Comment by Christie Keith — June 7, 2008 @ 7:13 am
Geez, another one saying it’s all our fault.
Sorry for the snark.
Where I live (northern New England) there are probably three cases of heartworm a year. They will not use my dog as an experimental animal.
Comment by Roberto — June 7, 2008 @ 7:31 am
There is a nice article out on the web about heartworm medication data by Rebecca Foxton on several websites. She uses FDA data from 2004.
http://furryfriendsonline.com/.....ventatives
Comment by Linda — June 8, 2008 @ 8:38 am
What does the “risk minimization and restricted distribution program“ consist of anyway?
By this….
http://www.vetsymposium.com/proheart6/
…it looks to me as if Fort Dodge (not the FDA) is “restricting” the distribution of Proheart6 to veterinarians who register/are certified (whatever that means) via a ONE TIME, ONE HOUR internet “training program“ hosted by Fort Dodge. And in the future veterinarians can register/be certified via the internet ARCHIVE of this event.
That’s just crazy if that is how they are selling their “risk minimization” promise to pet owners. I mean seriously, is that it?
So, “qualified” veterinarians will be ones who logged into the Fort Dodge website for an hour or read the archived transcripts of that company-sponsored web event?
Comment by Joy — June 8, 2008 @ 1:47 pm
“My point is if people were responsible and gave the pills we would not be having this discussion!!”
JJ: If the FDA/CVM hadn’t received 5,500 serious adverse drug reaction reports and more than 600 reports of death attributed to ProHeart6….THEN maybe we wouldn’t be having this discussion!
Comment by Joy — June 8, 2008 @ 2:03 pm
This is the first positive reaction I’ve come across to the return of Proheart6. It’s from a Vet who is planning to use it in his practice:
http://www.yourpetsbestfriend......veats.html
Comment by slt — June 9, 2008 @ 11:04 am
Interesting. He also is under the impression, corrected here by Christie, that ProHeart 6 is the same product being used elsewhere in the world.
Comment by Gina Spadafori — June 9, 2008 @ 11:28 am
Christie, I look upon you as the resident expert on adult heartworm infestations, having chosen to treat one of your dogs with the arsenic based Immiticide by Merial which leads to neurotoxicity (fast kill), and the other with the slow kill method of monthly Ivermectin dosages. That latter is what we all do when we give our dogs Heartgard and the like by the way. We are assuming our dogs become exposed and treat accordingly. Interceptor is Milbemycin oxide, a somewhat different drug but works on the same principle.
What is the time released drug being used in Europe…Selamectin? I thought that was the avermectin in Revolution. What are the Europeans using that is different from Moxidectin/Proheart 6?
And if you have a smooth or rough collie, an aussie, a sheltie, a Long Haired Whippet, A Silken Windhound or another breed that traces it’s descent to a specific collie in the mid 1800s in Britain, you better spring for a sensitivity test to make sure the lethal MDR1 allele is not present in your dog. This would also include any mixed breed dog in my book whose antecedents are unknown. Nothing worse than thinking you are doing the right thing, and causing the death of your dog because you didn’t know she had an allele that can’t process P-glycoprotein.
So as far as Pro-Heart 6 is concerned, the answer is No, there is still too much risk involved, and treating to prevent heartworm is risky enough as is.
Comment by Deb — June 9, 2008 @ 3:35 pm
See now, i liked the daily dosing regimen of Diethylcarbamazine (DEC) used in Filaribits, Carbam and Nemacide tablets. But I don’t know if you can even get those anymore.
So Christie - were they better, worse, or about the same as what gets put into our dogs’ bodies with the monthly dosages?
Comment by The OTHER Pat — June 9, 2008 @ 4:02 pm
Here Pat. The links are about halfway down the page.
http://www.dogaware.com/heartworm.html
Comment by Deb — June 9, 2008 @ 4:58 pm
Hi, sorry I’m getting here so late in the day!
The issue with Proheart 6 vs Proheart 12 is not clear, but the SPECULATION I’ve seen, which may not be correct, is that the different size microspheres that allow the drug (it’s the same active ingredient) to be “time released” are responsible for the different side effect profiles in American dogs (Proheart 6) vs dogs in other countries (Proheart 12).
I don’t know what changes were made to the drug prior to this re-release, nor if they relate to the microsphere issue. I will put in a call to Fort Dodge tomorrow and definitely post what I find out!
Comment by Christie Keith — June 9, 2008 @ 10:06 pm
As to comparisons of the different types of heartworm “preventive” (retroactive wormers), I prefer to use Interceptor at the “Safeheart” dose, which is an FDA approved dosage, prescribed by my veterinarian.
I no longer give my dogs heartworm medication since I’ve moved back to San Francisco, where we have no heartworm, but when I lived in Sonoma, that’s what I did. Info here:
http://www.fda.gov/cvm/FOI/1365.htm
Please note you cannot buy “Safeheart.” You can only use the reduced dosage of Interceptor. Print out the FDA information and take it to your vet if you want to discuss it — that’s what I did.
Comment by Christie Keith — June 9, 2008 @ 10:13 pm
I took my dog to the vet for his 5000 mile check up and now he is in very bad shape. Why? Because I was informed of this 6 month heartworm medicine that would be more convienient to administer. Anyways, Apollo my Siberian Husky is down for the count, every symptom that I have reseached on this product today he has! He was given the injection on Wednesday July 9th today is Saturday the 12th and I just got him out of the hospital with some anti biotics to clear up a Kidney infection possibley caused by the Proheart 6 injection. I personally do not believe this product should be on the market for dogs, it is smply not worht the risk, and I urge people not to use it after what I have been going through the last 72 hours. Please get yourself informed before using it. My name Greg Harlan I live in Beaufort South Carolina (912) 308-8943 I will gladly speak to anyone about the situation I am in with my dog. Stay away from ProHeart 6!
Comment by Greg Harlan — July 12, 2008 @ 3:03 pm
I am very sorry to hear this Greg and I hope your dog makes a full recovery. Did your Vet advise you on the possible risks with the product and have you sign a waiver in advance of the injection? Has your Vet reported the reaction to the FDA?
Comment by slt — July 12, 2008 @ 4:09 pm
This is how I was informed on the risks of Proheart 6. I have two dogs, one is a Siberian Huskey and one is a White German Sheperd, I took Apollo at 1000 in the morning on Wednesday and Vader at 1500 that afternoon. When I brought Apollo I was told about the drug being back out and I asked about it, all that was told to me was that it only costs a dollar more that the chewable version so I decided sure why not since it is the same thing. Apollo gets his injection and the rest of his shots to include DHLP-P, Coronavirus, Bordetella, Deworm Fenbendazole (I have no idea why they gave them dewormer they don’t have worms)and Proheart 6. He was given a Fecal flotation and Occult heartworm test both turned up negative. I then brought Vader my Sheperd in the afternoon and he got the same shots, then I was handed a form to sign and on that form was all the risks and side effects of the drug, I then stated to the receptionist that if I knew this I would never have gotten the shot for either dog and stuck with the monthly chewable that they have had no problem with. So yes I was informed of the risks, after they got the shots. I never knew about this product and the controversy surrounding it before the 9th of July, the day they both got the shot. One point though is the fact that Vader is showing no symptoms of the side effects but Apollo has all of them. And one other thing, DEATH was not on the little sheet they had me sign, but it seems to be one of the side effects that I have seen doing my research on this product. I personally believe that the consumer should be fully informed to include the number of deaths that have occured from the use of this product and the number of survivors who have had no issues, that would be fair for the consumer to be able to make a more educated assestment before they pay to have thier dog poisoned. And for the people who are blaming the irresponsible pet owners for the problem of this product, I invite you to my house at 606 Dahlia Dr. in Beaufort, South Carolina and look at my Apollo and the tell me its my fault! I never had an issue with the chewable and I should have stuck to it, and I should have been better informed before I allowed it to be used on my boy. I was not properly informed and I doubt the majority of Vets out there are putting “DEATH” on the disclaimer or release form, they should also be telling the client that this is a limited release and “your dog is a Guinea pig for Fort Dodge”. Once again my personal number is 1(912) 308-8943 I will talk to anyone about this. Thank you. Greg Harlan
Comment by Greg Harlan — July 13, 2008 @ 6:49 am
Greg,
It sounds as if your Vet may not be in compliance with the Fort Dodge and FDA recommendations for this drug - bigtime. As such, I wonder whether he will report the adverse reaction if he himself didn’t follow protocols. I hope you will contact both Fort Dodge and the FDA with the details of your experience as you explained here. Unfortunately, since your Vet did not follow the protocols, I fear Fort Dodge will try to dismiss your dog’s reaction as having nothing to do with Proheart. Still, I hope you will at least provide them the information.
I hope Apollo is restored to health as quickly as possible.
P.S. I didn’t know Panacur (Fenbendazole) came as an injectable. I’m only familiar with it in oral form, given in daily treatments for a prescribed duration.
Comment by slt — July 13, 2008 @ 8:48 am