Here’s an update on ProHeart-6. Fort Dodge held their web seminar to educate veterinarians who want to use the product. In order to buy the stuff, you have to sign in (whether or not you listen), then register at the end by clicking all the boxes that say you agree to their stipulations for use. So, now I can order the product… but, do I want to?
In my previous post, I indicated strong interest because of the problems we are having with our large-breed, outside dogs getting a few heartworms, despite taking regular monthly preventive. That is still some incentive.
I have to balance that against all the conditions that we are required to fulfill before using the drug in one of our patients.
The gist of yesterday's educational program covered how safe they think it is, and what they are doing to prove it. Here’s what they’ve been doing so far:
First, there’s the fact that the product has been used continuously since 2000 in Italy, Australia, and Japan and nobody over there believes they are having any problems with it.
Second, they have done toxicity studies with rats and mice (and some dogs) giving hundreds of times the recommended dose, and all those experimental subjects did just fine.
Third, all the ProHeart-6 (and the same product with a different name used overseas) are made in one factory, right here in the good old U.S. of A. The last time that they changed a raw-material supplier was 2002, so we don’t have to worry about any of that contaminated Chinese stuff in our ProHeart-6.
Fourth, they have tested it in combination with many other types of drugs, and there are no problem interactions.
The next phase of proving how safe this stuff is will be their "pro-active Risk Minimization and Prevention" plan, the RiskMAP that they have agreed upon with the FDA-CVM. Every veterinarian who uses the product agrees to report any adverse reactions associated with it. Fort Dodge will collect these and report on them every month, instead of every year (the usual procedure).
Now comes the tricky part: we aren’t going to use it in any animal who has, or has had, or might have any condition that might cause or could be conceivably confused with a reaction to ProHeart-6. If the dog is not 100% healthy and in the prime of life, we don’t give it to him. ALSO, we are going to document that the dog is 100% healthy and in the prime of life. We are going to do this by taking a good medical history (already doing that), doing a complete physical exam (already doing that), and testing to be sure he is heartworm-free (already doing that, too).
If he’s over seven years old, he doesn’t qualify. He’s getting old enough that he might get some age-related problem (Tough break, old-timer.). If he’s younger than six months, he doesn’t qualify (presumably, because he might have some congenital condition that could be confused with a ProHeart-6 adverse reaction. In the web seminar Q&A, the answer to this one was "that’s what’s on the label"… ho-o-kay…). If he’s underweight or has lost weight, he doesn’t qualify (might be sick, get confused with an adverse reaction).
You can’t give the ProHeart-6 injection within 30 days (before or after) a vaccination. That means you will have to schedule a different appointment, at least a month away from your normal yearly check-up.
Oh, and to help prove that you are one of the favored few who are 100% healthy and in the prime of life, a complete blood count and biochemistry profile are required before starting. Whoops, there’s a bit of an extra expense. We often do yearly bloodwork in our senior patients, but (by definition) we aren’t talking about senior patients here.
So, if you’d like to use ProHeart-6, all you have to do is schedule an extra appointment, get some extra labwork, prove that your dog is 100% healthy and in the prime of life, read your handout, and sign the release form stating that you understand it all (including risks of adverse reactions). You can visit their new website for the official line, but I think this means that we are paying for the privilege of doing "beta testing" for Fort Dodge Animal Health.
Do I think it's safe? Probably.
Do I think it will work? I hope so.
Will I be using it? Maybe.