Wyeth's ProHeart-6 injectible heartworm medication made by Fort Dodge was recalled from the market after it killed a few hundred dogs and made thousands of other dogs seriously ill.Now Wyeth is trying to get it back on the market and avoid liability by limiting its sale to veterinarians who register with the manufacturer and complete a Web-based training program and have pet owners sign consent forms to absolve the manufacturer of liability.
Don't you just want to rush out and buy this product??!!
The good news is that Republican Senator Charles Grassley of Iowa (pictued top right) is asking a lot of questions.
In a letter to FDA Commissioner Andrew von Eschenbach, Senator Grassley asked whether any FDA safety experts had been involved in the more than 18 meetings and 85 phone calls between the agency and Wyeth's Fort Dodge unit to discuss the drug. You would think and hope someone other than GS-15 bureaucrats and political appointees had been involved in those phone calls and letters, but if Sen. Grassley is asking the question there's some question as to the answer.
Sen. Grassley also wants to know if the new version of the drug has been tested on dogs at all. His sources say it was not; it was only tested on Guinea pigs.
Test the product on dogs?? You would think that would be a no-brainer, but then again if Senator Grassley is asking the question, there's some question as to the answer.
Considering the track record and legal caveats surrounding ProHeart-6, why would any veterinarian recommend ProHeart-6 to their clients when other medications are available?
Simple: for the money.
And of course, because they think their customers are idiots which they would have to be to sign a consent form saying "You can kill my dog and I have no legal recourse".
- Related Post:
** The Billion Dollar Heartworm Scam
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6 comments:
I have read other posts on this topic also questioning whether it's wise to test this drug on vet client dogs but here's a post from a Vet planning on using Proheart6 in his clinic:
http://www.yourpetsbestfriend.com/your_pets_best_friend/2008/06/proheart-6-returns-with-caveats.html
I'm not as down on the veterinary profession as you are, but I'd be interested in finding out more about this vet, ie, affiliations.
For me, even without the obvious and completely unnecessary risks (Revolution user here for years with no adverse effects), just hearing 'Fort Dodge' (I alwasy ask about brands) makes me say, 'No, thanks' on the advice of my former longtime vet (not a GP any more) who is also a personal friend.
Why would anyone even consider using this product when there are so many efficacious drugs out there?
I'd rather take my chances with the parasites!
This veterinarian is a bit quick, a little flip, and not all that well-researched.
Let start with her wording about how ivermectin works: it's wrong. Heartgard (ivermectin) is not a preventative; it's a treatment. I do not mean to be picky, but in fact this is an important point, as it tells you what the drugs do in the body of the dog. She should have mentioned it at least once; perhaps she does in another post, but it left me wondering ....
Second, she says that until ProHeart6 was withdrawn, she did not know there was a problem with this medication. OK, but the problems with this medicine was not a closely held secret. In fact it was a pretty noisy controversy, which is why the pull by Fort Dodge was done (the FDA allowed them to pull it voluntarily).
Third, this vet is not doing the math and/or does not understand how to do risk assessment. If a few heartworms make it to adulthood in a dog (very unlikely) and are made sterile by ivermectin and doxycycline, they will NOT kill a dog or impede its function in any way and will disappear on their own after 18 months. This vet more or less gives a nod to this reality (though mention of the role of doxycline in heartworm eradication should have been noted in my opinion)
However, in a known (and not too small) number of cases ProHeart6 has been know to KILL dogs outright. This is what we call a ZIP function: near ZERO chance of it happening, but INFINITE POTENTIAL harm if it does. And YES, patient death "is a bad thing" (her words) because there is no coming back for the dog after that. If you can avoid that possibility without a down side (by using ivermectin), you should do that.
Let's go to the FDA press release on ProHeart6 and see what it says about this drug. We can read it at >> http://www.fda.gov/bbs/topics/NEWS/2008/NEW01844.html
First of all the FDA press release says this drug was previously associated with "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." That's not what the drug sales rep will tell you, I am sure, but it's the truth in black-and-white.
Second, the FDA is only allowing a "limited return to the U.S. veterinary market" because they still have real concerns about this medication, and those concerns are sufficient that they are requiring Vets and Dog Owners to use this product ONLY if they sign a formal release and go into it "eyes wide open."
Third, the FDA warning label explicitly says ProHeart 6 is NOT to be administered within one month of vaccinations, and should not be used with dogs with pre-existing allergic diseases including food allergies, allergic hypersensitivity, and flea allergy dermatitis. The label also warns against administering the drug to dogs who are sick, debilitated, underweight, or who have a history of weight loss. In addition, the label’s Post-Approval Experience section has been updated to include information about adverse reactions based on voluntary post-approval drug experience reporting.
In short, this medicine has a LOT of black box warnings on it, and the most important is that it can kill a dog. The old system of ivermectin treatment, however, CANNOT kill a dog if it is actually followed up at least once a month or so.
This vet says there were "no apparent problems" with this drug overseas.
This is simply not true.
As the FDA notes at >> http://www.fda.gov/cvm/ProHeart6Update_0608.htm "[Since 1994] there has been a decline in the adverse event reporting in international markets...." which is a nice way of saying there WERE reports of problems overseas which appear to have diminished now that the company is making a less adulterated (i.e. a less contaminated) product.
What is not known is if everything is allright now. Your dog, if you so choose, gets to be the guinea pig to help answer that question.
How serious are the prescription restrictions on ProHeart6? Consider this: it's not enough that one vet in the practice be trained. ANY vet that prescribes this drug has to take the online training. See the yellow box at >> http://www.vetsymposium.com/proheart6/
And read the package insert too >> http://www.fda.gov/cvm/Documents/Proheart6ProductLabel.pdf
Those are the facts; you can do the math and asses the risk yourself. I would not blindly follow whatever a vet said on this matter. In fact it is illegal for you to do so, hence the written and signed disclosure and waiver before this drug is administered to your dog.
As I have said about veterinary medicine before, vets are NOT a disinterested party when it comes to presciption medicines.
A medicine that requires another visit to the vet to be administered is called a "ka-ching" drug; you can practically hear the cash register ringing in the waiting room.
Patrick
She's posted before on Heartworm medication, worrying that worms are becoming drug-resistant because even 'more and more' regularly dosed dogs test positive for heartworm lately.
To this vet's credit she is rethinking this after going to a training and learning that not only does the patient have to come in for another visit, AND sign a release accepting all liability, but there will also be a complete run up of blood work. Apparently the conditions put on this med are ringing some alarms! See >> http://www.petconnection.com/blog/2008/06/13/proheart6-uh-never-mind/
P
My beautiful, gentle, golden retrieve,Hunter, was a victim of proHeart6 on it's "first outing." He was 4 years and 2 months old when ProHeart6 (my vet is the one that told me the PH6 was the culprit) brought on autoimmune hemolytic anemia and liver damage. Those were two of the leading reactions that caused deaths. My boy spent 8 days in ICU from day of diagnosis of AIHA til his death, the bill being $2300He was on massive amounts of drugs, had 2 transfusions. But something like 50% of dogs die within a week of diagnosis of AIHA, another 30% in a month. And he was also battling drug induced necrosis of the liver according to his histopath report. Yes, we had a necropsy done.
There were some who took in 2 dogs the sam day for PH6 injections, and lost both dogs. One in Colorado took in her 11 year old "skipper key", a 4 year old mix that looked oike a big cotton ball, and a 2 yea old shepherd/lab mix. In a couple of months the first 2 wer dead,one of AIHa, the other of liver, and the 3, the youner one is on meds 6 years later fotr autoimmune problems. One in Florrida took her two in and lost the pom and the sheltie was sick and on drugs for a while.
Many of us fought together to spread warnings about proHeart andto try to get it removed from the market and we are still in contact and upset that it is coming back. Most of us truly believe our dogs were used as "test subjects".
when it was out the fist time it was suppose to be "so safe" that it could be fiven to heart worm positive dogs--til they started droping dead and the FDA had Fort Dodge make a label change. Then all the reports of AIHA, seizures, lver problems, started coming in nd theFDA had them change the label once again. Finally, death was including, and ironically, it was included the day my Hunter got his fatal injection. They were denying that their product was at fault. however, many, many were paid off...they had to sign a release saying they would never discuss thei settlemnt, nor revieal any data, information, dicovery, etc, with any person or entity under any circumstance.
I refused to sign and zip my lip. I felt I owed it to the dogs to let folks know what it had done to my dog....and many others.
now they are saying it has been reformulated and the residue that appears to have caused so many severe reactions and deaths the first time has been removed. To me tha says they know it was a killer e first time. Burn me once, shame on you, burn me twice, shame on me. Proheart6 will never be given to another dog or mine. For more, go to www.dogsadversereactions.com and click on the moxidectin section and you can go to the memorials and survivors pages and read may storeis--and see the pictures of these dogs--who were either lost or almost lost to PH6, including my Hunter.
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