You may recall that I posted previously on my concerns about our heartworm preventive medicines becoming less than 100% effective. There seems to be no difference in efficacy between the different medications, nor does it appear to be dose-related (i.e. giving a 100-pound dose to a 51 pound dog doesn't guarantee effectiveness). I even tried dosing my own dog twice monthly, using different preventive medicines (she got heartworms anyway -- not bad, but she has them).
So what if they were taking preventive medicine constantly? That's what we used to do with daily preventive medicine, but we had trouble getting all the dogs medicated every day, year round. We had compliance problems from both the dog and the owner.
We also used to have continuous daily heartworm preventive medication that was pretty much trouble-free. ProHeart-6 was given by injection once every six months. It was a timed-release medication -- basically, you injected a blob of medicine under the skin and it slowly leached into the bloodstream for the next six months. I didn't have a lot of clients on the product, as it didn't control the intestinal worms like Heartgard-30 or Interceptor, and it didn't control fleas like Revolution. Also, we had occasional problems with people coming in a month or two late for the next injection (not good). We had no medical problems with the product, though.
That's why I was flabbergasted when (with no warning from the manufacturer, Fort Dodge Animal Health) the product was pulled from the market. It was all over CNN after I went to bed, and I didn't look at Veterinary Information Network until after clients began calling on the Saturday morning in September 2004. The FDA mandated its removal, citing many adverse reactions, including patient death (which I admit is a bad thing).
The funny thing (funny-strange, not funny-haha) was that the product continued to be used in other countries around the world with no apparent problems. No explanation there, just the FDA "looking out for us" ( I guess Fort Dodge didn't slip them as much cash as Eli Lilly, whose psychotropic drugs list everything they are prescribed for as potential side effects, including suicide. I don't feel like the FDA is looking out for us so well, there.).
Well, ProHeart-6 is coming back, but I can't buy it until I complete my one-hour web seminar this week. It will only be available through a "restricted distribution program", whatever that means. Not only will we not be using it in sick or debilitated animals, we also won't be using it in animals that are underweight, or who have history of weight loss (this being America, there won't be many of those). AND we can't give it within one month of vaccinations. What that says to me is that they don't want to get blamed for any vaccine reactions. Fort Dodge doesn't want to take any lumps for somebody else's lumps. I can certainly understand that, since it took them four years to get the stuff back on the market. On the other hand, I know that my clients won't exactly be happy about having to schedule extra visits.
On the other hand (is that three hands?), if ProHeart-6's daily continuous release of medication makes it 100% effective in those big outside dogs, they will be picking up more market share with my big, outside dog patients. I'd sure like to be able to give people back the confidence they used to have in their heartworm preventive.
You won't be able to give me back any confidence in this product. When this product was originally pulled off the market, the FDA cited over 5,500 adverse reactions, over 500 deaths, "some" of those deaths linked convincingly to the medicine, according to an MSN article. In addition to death as an undesired endpoint, the non-fatal reactions of lethargy, bleeding, vomiting, heart and liver problems, and seizures are side effects I would think not desired from a quality of life point of view, especially when potentially experienced for the duration of the 6 months of the time released medication.
I am skeptical about ProHeart 6 being the answer we are seeking for prevention of heartworms.
Posted by: Sheila | June 09, 2008 at 07:21 PM
The FDA press release makes some noise about re-formulation. I've seen the statistics relating to the original withdrawal. In Australia they have a 12-month product with moxidectin, available for several years now. I have to wonder why the product doesn't appear to be generating any reported problems in the other countries. It's hard to believe they just have a higher level of acceptance on sudden death. For me, it's a case of "the jury is still out".
Posted by: Doc | June 10, 2008 at 09:37 AM
Couldn't it be that the 12 month dose of the product used in Australia is a different formula (however slight) from the 6 month product which killed the dogs in the US? And that whatever that difference is, it accounts for the different safety experiences in each country? Has the new product (which is about to be released) been tested on dogs?
Posted by: YesBiscuit! | June 11, 2008 at 05:30 AM
The new product is exactly the same as that used overseas. There was some reformulation in 2002. The 12-month just has more product in the injection. Both have been tested in dogs, but check out the later post on this subject.
Thanks for reading and writing.
Posted by: Doc | June 14, 2008 at 04:03 PM
Pro-heart 6 was reformulated in 2002 and then we all know it was pulled off the shelves in a recall in 2004. Well, it has been relaunched and the formulation has not been changed -- same product that was recalled. Also this launch is called a "Risk Minimazation Program" - basically a field trial study that Fort Dodge is doing and making the vet's clients pay for and having the client's pets be the guinea pigs for the study. Also, the vet has to go through a webinar, then sign a waiver, and then the client has to sign a sheet saying they have been given all the warnings -- so what are these sheets? Is Fort Dodge trying to have no accountability and put the liability on the vet and client? Who knows, but makes me wonder. I would be cautious jumping on the Proheart 6 bandwagon quickly as a vet or as a pet owner. Best of luck to you all!
Posted by: DogLover | June 27, 2008 at 10:07 PM
I agreed to the injection on Wednesday the 9th of August. Today is Saturday the 12th and my dog is in bad shape! He displays all the symptoms that have been reported in the past on the adverse effects of this product. Now my dog has a severe kidney infection and is not doing well at all. This product does not belong on the shelf until they know what is causing this problem. My dog is an unknowingly and poorly informed guinea pig on this product and now I could loose him. I will never believe that this product is OK and SAFE I could care less what is being done in other countries.
Greg A Harlan, Beaufort South Carolina (912) 308-8943 I will talk to anyone about this and take action.
Posted by: Greg Harlan | July 12, 2008 at 01:52 PM
Correction to previous post it should read 9 July not 9 August
Greg A HArlan Beaufort South Carolina
Posted by: greg harlan | July 12, 2008 at 01:54 PM
Greg,
I am sorry to hear about your situation. I am assuming that your veterinarian did the pre-injection blood-work so that we know your dog did not have a pre-existing problem. Your doctor will have reported this adverse reaction to Fort Dodge.
Even though your dog is doing poorly now, I am sure that your veterinarian is doing everything he/she can to bring you guys on through. Don't give up hope.
Thanks for reading and writing.
Posted by: Doc | July 12, 2008 at 05:42 PM