Dog Owners Beware

One of our beloved dogs, Jack, a 6-year-old, chow-lab mix, died yesterday. His death was very unexpected and traumatic. Although, our dogs did not receive the same amount of attention as they did before Bobby was born, they were still loved dearly. Bob walked them religiously every single day. Jack loved, loved, loved, playing fetch. Tennis balls were his favorite. When we discovered that he had died, we began questioning what happened to our sweet Jack.

On Monday, May 7, 2012, we took both of our dogs to our vet for their annual check ups. It was a very routine visit. They were both checked for heartworms and parasites, weighed, and listened to. They were deemed normal and healthy. They both received their rabies vaccinations, and a new drug (via injection) that was recommend by our vet, ProHeart 6. Our vet simply said, “Hey, we have this new shot that we can give them for heartworm protection instead of an oral preventative. It’s easy because it’s only one dose every 6 months.” Sounded good to us, so we agreed. That was it. That was all the information we received, and—by our own fault—all we asked for.

Both of the dogs seemed fine the first week home, then Jack started acting differently. He didn’t want to go on his daily walks. He didn’t want to fetch his tennis ball. He didn’t want to eat his dog food. My husband even tried giving him some leftover steak from our dinner, and Jack wouldn’t eat it. We knew something was up, so we took him back to the vet on Monday, May 21.

The vet discovered that Jack had a fever, but could find nothing else wrong with him. He was given a steroid shot and some antibiotics in case he had an infection, and we were sent home. Over the next few days, Jack seemed to feel better. He was still a little lethargic, but was eating and perked up when we threw a ball or petted him. He seemed on the mend. We thought he must have just had a virus and was getting better. It did not even cross our minds that he was so gravely ill, so we continued with our Memorial Day plans to go to the beach.

We returned from the beach to a grim discovery—Jack dead in a pool of blood and vomit. His poor little body was crumpled up in a strange way, like he had literally just fallen over dead. We took him to an animal ER where they confirmed that he was dead, and we paid to have his body cremated. The vet at the animal ER stated that it appeared to be a heart attack or cardiopulmonary problem that killed him.

That evening, as we wrestled with grief and trying to explain death to our 3-year-old son, we began to question what on earth had happened to our previously perky puppy. Okay—he wasn’t a puppy, but he always behaved like a frisky, fun puppy, and he certainly wasn’t an old dog. We considered the possibility that he ate something bad, but his vet had all but ruled out a GI problem. We went over and over what was different, the only thing we had changed was their heartworm medicine.

We googled the shot he had received a few weeks earlier, ProHeart 6. The drug was originally made by a division of Wyeth Pharmaceuticals, but the drug company Pfizer acquired Wyeth and all of its holdings in 2009. Pfizer’s own website lists side effects of the drug as lethargy, loss of appetite, vomiting, and death. (Source: Pfizer) Jack had exhibited exactly all of those symptoms… in that order.

After doing further research, we also discovered that the drug was originally pulled off the market in 2004 for a high rate of adverse reactions to the drug. “According to an informed veterinarian, ‘Proheart caused more deaths in one year than all of the oral heartworm preventives combined did in ten years. When the FDA notified Pfizer that their drug was causing a problem, the manufacturer claimed it was due to the vaccines’ being given at the same time. The FDA looked at the data again and told them the dogs involved had been getting their vaccinations all along and the only difference was the Proheart. That’s when the FDA informed the company of their intent to pull it and the company then voluntarily took it off the market.” (Source: The Senior Dogs Project)

Pfizer was allowed to re-market the drug in 2008 with the following stipulations: Pfizer agreed to add additional warning labels to the drug packaging, and agreed to mandate that pet owners be given a drug fact sheet and be made to sign an “informed consent” document. Pfizer went even further as to mandate web-based training for veterinarians who gave the drug, and issued several “Dear Doctor” letters to all veterinarians regarding the adverse effects of the drug. (Read one of the “Dear Doctor” letters here.)

The part that bothered and alarmed us the most was this line from the drug’s website: “ProHeart 6 dog owners must be advised of the risks of ProHeart 6 and sign an Owner Consent Form prior to the first administration.” (Source: Pfizer)

We were never shown a fact sheet on the drug, never “advised of the risks”, and certainly not given an Owner Consent Form” by our vet to sign. (In hindsight, we feel that we should have asked more questions about the drug, but we trusted our veterinarian.) If the side effects had been presented to us as they have in our research, we would NOT have consented to have Pro Heart 6 administered to our dogs.

We also found some literature suggesting that ProHeart 6 should not be administered at the same time as vaccinations: “Allergic reactions, sometimes serious, have been reported when ProHeart 6 and vaccinations have been given at the same time. Talk to your veterinarian about the risks of administering ProHeart 6 at the same time as vaccinations.” (Source link here.) Our vet administered ProHeart 6 at the same time as Jack rabies vaccine, and distemper/bordetella.

The drug’s information page from Drugs.com states the following: “Owners should be advised of the potential for adverse reactions, including anaphylaxis, and be informed of the clinical signs associated with drug toxicity. Owners should be advised to contact their veterinarian immediately if signs of toxicity are observed. The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized and veterinary care, if appropriate, is initiated.” (Source: Drugs.com)

When we did recognize that something was going on with our dog, we did what we thought good pet owners are supposed to do. We took him back to the vet. The vet should have recognized that he was having an adverse reaction to the ProHeart6 that she administered to him (without our “informed” consent) only weeks earlier and treated him appropriately. If the vetrinarian had recognized his symptoms, he could have recovered. She did not, and as a result, our otherwise healthy dog died. Now, we are left waiting on the drug to work its way out of our remaining dog’s system praying that she does not fall victim to the same fate.

Stories of dogs that died as a result of being administered this drug are abundant. Check out any of the following links for more information, and please, ask for all of the facts, side effects, and more information when your vet (or doctor) recommends this drug (or any drug). ProHeart 6 provides no additional benefits or protection than safer, oral heartworm preventatives.

Additional Resources:

Letters & Data by the Drug Manufacturer from the FDA’s Website:

July 22, 2002 “Dear Doctor” Letter warning of additional “adverse reactions”

June 19, 2003 “Dear Doctor” Letter advising of label changes due to “adverse reactions”

“Risk Minimization Action Plan” for the Re-Introduction of ProHeart 6 to the Market (63 Pages which includes the newest precautions, and the actual drug label, “Client Information Sheet”, and “Owner Consent Form”—none of which we were ever given.)

UPDATES

May 30, 2012:
I truly appreciate all of your condolences and support, and all of you who have shared this blog on your social media sites. It makes me feel much better knowing that we are raising consumer consciousness.

We aren’t trying to tell you what to do with your pets, just encouraging you to gather information before making any decisions.

A vet that works for Pfizer, the drug manufacturer, contacted us today to ask us if we would let them do an autopsy necropsy on Jack. (They had already called the crematorium to make sure his body had not been cremated yet.) We agreed. In fact, we felt relieved and feel that we will get some answers soon. His body is now on the way to the University of Florida to be examined by experts.

Our other dog does not seem to be exhibiting the same symptoms (so far thank goodness).

May 31, 2012:
Pfizer called back today to let us know they were planning on reimbursing us for the money we paid to have Jack cremated.

His body is being sent to a different lab in Florida and it will be 4-6 weeks before we get a full autopsy necropsy report. They are doing tissue samples, toxicology… The whole nine yards.

Pfizer seems as interested in getting answers as we do. Which is more than we can say for our (former) vet.

The vet has not responded to our requests for answers. (I.e. Did the vet who administered the shot complete Pfizer’s mandatory training? Why were we not given the “Owner Consent Form” and drug fact sheet? Why did the vet not recognize Jack’s symptoms when we took him back in?)

I have received lots of emails and messages from others who have lost their pets. My heart goes out to you. Some have asked me to publicly name the vet. I’m not going to do that (yet). I may, or may not, do that when we receive the autopsy results. At that time, we will know who is truly culpable. In the meantime, just be sure to ask your vet (or doctor for that matter) for lots of information before consenting to anything.

June 8, 2012: We received a condolence card from our vet. It did not address any of our concerns, but it expressed sympathy for our loss.

July 11, 2012: We received a check from Pfizer in the amount of $ 69.50 to reimburse us for the money we spent to have Jack cremated. (He was not cremated, as Pfizer took possession of his body to do the necropsy.)

July 24, 2012: Necropsy Results

Pfizer called and spoke with my husband regarding the results of the necropsy. Their findings were inconclusive. Jack had a small heartworm in his heart, but no damage to the heart. His toxicology revealed that he had slightly elevated levels of vitamin A and zinc. That was it. There was no obvious cause of death. Pfizer stated to my husband that they do not believe ProHeart 6 caused his death, especially since so much time passed between when he first received the medicine and when he died. (Total time from when he received the shot to his death was 5 weeks.)

I also spoke with a vet from the Alabama State Board of Veterinary Medical Examiners (ASBVME) today. He basically stated the same thing that Pfizer said regarding the drug.

He said it is unlikely that the drug caused Jack’s death since 5 weeks had passed since he had been given the drug.

He also said that he had spoken with the vet who administered ProHeart 6 to Jack. The vet admitted that she did not give us an informed consent form to sign. She apparently did not know such a form was required by the FDA. The ASBVM let her know that obtaining the consent form for ProHeart 6 is a federal requirement (required by the FDA). I have some opinions on her lack of knowledge, but I won’t speculate further on that topic. I was assured by the ASBVME that the vet in question, and the other vets in her office, were brought up to speed on the federal requirements of that drug.

Answers to FAQs and Other Updates: Our other dog, a rottweiler mix rescue named Katrina, is healthy and doing well. Our son still asks occasionally when we are going to go pick up Jack, if he can take Jack on a walk, or if he can go outside and throw the ball with Jack.

Of course, we will not be going back to our former veterinarian. We will be looking for a new vet who we feel is more up-to-date on current veterinary practices and is more communicative with pet owners.

Our Conclusions: The necropsy was inconclusive, so we cannot say what caused Jack’s death. I do still think that the timing and manner of his death are very suspicious. I also know that had the vet given us the “informed consent” document to sign prior to administrating ProHeart 6, we would not have consented, and we feel that Jack would probably still be alive.

While we personally feel that the timing of Jack’s death and the administration of this drug, combined with the symptoms of his death, make it possible that ProHeart 6 was a factor in his death, that theory is neither supported nor discredited by the findings of his necropsy. We cannot say it is anything more than a possibility.

Also, it is worth noting (in the spirit of full disclosure and honesty) that most dogs who have an adverse reaction to ProHeart 6 die much sooner/quicker than Jack did. (The total time from drug administration to death for Jack was 5 weeks.)

Our Purpose: My purpose in sharing our story with you is to encourage you to have candid conversations with your veterinarian, just as you word your doctor or pediatrician.

We do believe that heartworm preventative medications are important for our animals. We are not advocating that you skip this important medication. We just encourage you to discuss the different options available (oral, topical, injectable) with your vet.

Although we will not use ProHeart 6 again, we will continue to give our dog a heartworm preventative. We will also follow the state requirement of giving our dogs the rabies vaccine once every 3 years. Please check with your local authorities to see what medications you are required to give your dog, and please find a vet you trust and discuss each aspect of your animal’s care thoroughly before making any decisions.

***While the majority of comments have been supportive, some have not. You are entitled to your opinion, but please note that I will not publish comments that contain threatening or vulgar language. Nor will I publish comments that are anonymous. ****

***We are not veterinarians. Please discuss your concern’s about your pet’s health with a veterinarian certified by your state.***

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