Medical Info: Proheart

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I got an e-mail with some consern about proheart I am going to call the vet I worked for in Virginia and find some answers so until then I would say use heartguard or Interceptor.P.S. thanks to the e-mailer for the info.
FYI - Just watching 11pm local news and there is a special report on Proheart 6 injectable heartworm medicine.

Apparently there have been a lot of adverse reactions after receiving the injection. They say over 400 dogs have died now. I didn't hear all of the symptoms but some were weekness in the legs along with some other muscle type failure symptoms.

They interviewed some local vet that was against the injectables since they are so new and recommended the oral meds that have been around for a while like Heartgard.
Man that makes me so scared both of my older dogs got an injection before we left Va in January.I have been to several seminars about proheart.(all from their reps).I even waited a year before I tryed it. I am not going to use it again. I am aslso going to call Dr. Camron my boss back home. He will tell me all he knows and I will let you all know. Thank you so much for the info.
Fortunately the local news posts their reports online. Here's the info that they broadcasted about Proheart 6.

http://kyw.com/siteSearch/local_story_063171726.html
Thanks for the news report I think I might go trow up now. I must say both my dogs seem fine but I will never use pro-heart again.I was always leary of it but when I found out we were going to be gone for 3 months I thought hey this is the solution.
My chihuahua mix had to stay home whith my house sitter. (I miss him so much)I thought this would insure his heartworm safty.I have seen about a hundred dogs given proheart and I think only one had a problem and our vets made him well again.I wonder if there are any long term effects like they are finding with yearly vacc.
what med made Abby go into seizures? do you remember the name of it? Just want to be sure not to use it.Thanks( I think I am going to use Interceptor for Grizzy)I have used it most of my 8 year olds life and she has never had any problems.I will not use Pro-heart ( ProHeart or ProHeart6 ) again.
I had a feeling you we going to say revolution I am not a big fan of revolution.It just dosn't seem right to put Heartworm prevention on a dogs back.I am so sorry that your girl had such a rough time.I had even done my home work on the pro-heart and waited a year befor even trying it.Just goes to show you that nothing over time is 100% safe.I will say one thing for pro-heart we have a lots of people come to the Animal hospital who arnt capable of keeping up with their monthly prevention.So we give them the proheart Inj and send them a reminder in 6 months.At lest these dogs are safe from heartworms.
I know a lot of people are looking for information about 6 month heartgard, or heartgard pro, but they're really confusing heartgard with a new medicine called Proheart 6 ( ProHeart6 ). There have been some serious side effects attributed to pro heart 6 so I personally would think twice before having my dog injected with pro heart.
FDA HAS RECALLED PROHEART 6


http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01312.html
FDA HAS RECALLED PROHEART 6


Quote:
FDA Talk Paper
T04-37
September 3, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA



Fort Dodge to Comply with FDA's Request to Recall ProHeart 6 Injectable Heartworm Product from the Market Due to Serious Health Concerns

Fort Dodge Animal Health, of Overland Park, Kansas, at FDA's request, has agreed to immediately cease production and recall its heartworm medication ProHeart®6 from the market until the FDA's concerns about adverse reaction reports associated with the product can be resolved. FDA is requesting that the firm continue to conduct research to determine the cause of related adverse reactions and develop a strategy to help prevent such problems in the future before the product is marketed again. The FDA will convene an independent scientific advisory committee to thoroughly evaluate all available data.

ProHeart®6 is an approved injectable sustained-release heartworm prevention product for dogs. Heartworm disease is a serious and potentially fatal condition of dogs, cats, and other species of mammals. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.

FDA is also advising veterinarians to avoid administering this product to dogs until further notice. Pet owners should consult their veterinarians regarding their pet's health care needs.

Since the product was approved in June 2001, Fort Dodge Animal Health has cooperated with FDA to investigate numerous adverse event reports. As a result, Fort Dodge has voluntarily changed the label to include post approval safety information including rare reports of death and a caution to practitioners that dogs should have a negative test for heartworm before administration.

Despite these label changes, FDA is still receiving unexplained adverse event reports, some of them severe. FDA's concern is based on voluntary self-reporting to FDA by veterinarians and owners whose dogs have suffered adverse drug experiences (ADEs) to ProHeart®6 (which contains the drug moxidectin) as well as the mandatory reporting of adverse events by Fort Dodge Animal Health.

Fort Dodge Animal Health has agreed to recall any product that has already been distributed to veterinarians.

As of August 4, 2004, FDA's Center for Veterinary Medicine (CVM) had received 5,552 adverse event reports for ProHeart®6. The actual number of adverse events is likely even higher because studies show that only a fraction of actual ADEs are reported.

The Agency has observed an increase in the number of cases associated with liver and bleeding abnormalities followed in some cases by death.

####

http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01312.html
Please post in this thread if your dog has been treated with ProHeart®6.
Tell us about your experiences, good or bad or indifferent.
Thank you Ron. I had just recently talked to my mothers vet about Proheart 6. They hadn't heard anything negative about it and thought it was just as safe as any other product out there. I am glad I didn't choose to use it as well. My vet recommended to just stay using the heartgard. Thanks for keeping us updated. Stormi
My 18 month old OES went into shock about 10 minutes after receiving her DHLPP, Corona, Rabies and ProHeart on June 22, 2004. They took blood for a heartworm test prior to the inoculations which came back negative. I chose to have them done at a weekly shot clinic held at a nationwide chain because the cost was about half of what my regular vet charges for the same shots. I had recently had a full check-up with my regular vet during a visit for an ear infection and she had checked out fine. I felt it was safe to go to the clinic and at the same time prudent to pay half the price. Luckily, the receptionist was slow at check out as I was still in the building when she went down. Otherwise, she could have died in my car on the ride home.

The first indication that something was terribly wrong was when I heard someone snicker in the waiting room. I looked down at my feet and discovered I was standing in a huge puddle of urine and my pup was sitting in it. Convincing her to move seemed difficult. I thought I was imagining this. Embarrassed, I quickly began cleaning up the puddle with the roll of paper towels the receptionist provided. As I finished up I noticed a single fresh poop on the floor next to my pup who was then laid out cold. No one in the packed waiting room said anything to me. My pup lay on her side, tongue hanging out, next to her feces while I cleaned up the urine puddle. My only hope is that she went down moments before I noticed and those watching were too engrossed with my inept cleaning abilities. I stand by my belief in the supremacy of dog over human and I will never understand human beings. As soon as I noticed the poop I knew their was a serious problem and I began screaming "My dog is in shock. My dog is in shock. Get someone out here now!!!" Finally, in what seemed like an eternity, three vet techs ran out, scooped her up, and ran back to their surgery. There, they shaved nearly half of her front leg for the saline I.V., gave her steroids and a Benydryl type product and then installed a catheter. I intensely watched the faces of the techs and vet through the window in the surgery door as I could not see my pup. Thank God they knew what to do and when to do it. I am grateful for their skills in this area. She slowly came out of the shock. I was numb at this point. Once my baby was safe at home, in my bed, I cried over the near loss of my sweet, innocent Sheepie. She received the shots at 2:30 p.m. and we walked out of the clinic at 7 p.m.

I cannot begin to express how guilty I have felt for not first investigating results other dogs had to ProHeart. The vet and her intern both professed it's safety as I questioned them before the injections were given. They began the inoculations by giving her an oral wormer, part of the ProHeart package. I had not been told about that part. As they poured it down her throat, I argued that there was no diagnostic reason for it. They said it could not hurt her. She immediately threw it up. My pup had had a fecal exam a short time ago and it was negative. I felt stupid for going along with it. I have subsequently learned that my usual vet does not believe in the safety of ProHeart or use it. The FDA's ruling appears to validate my vet's understanding of the situation. The day cost me nearly four times what it would have cost at my vet's office. The future cost to my babies health and psyche are still unknown. The following day I took her to my usual vet for a full exam to determine any damage not visually detectable. None was found at that time. My vet told me problems, though rare can show up a long time after the fact. I force myself to be optimistic about the future.

I am happy to hear of the FDA's action against ProHeart. This product was obviously not tested thoroughly enough since so many problems have been reported. The clinic vet concluded my pup probably had an allergic reaction to the Lepto. My regular vet and I thought otherwise but did not report the incident. I did not even think of it. I am angry at Fort Dodge for covertly taking advantage of my pup. I am angry at the clinic vet for not explaining all the risks associated with ProHeart. I am angry at myself for simple stupidity. I have learned to: no longer take the word of any vet as gospel, not cut corners where the health of my baby is concerned and to investigate everything that goes into, on, or around my puppy.
I have been reading all that I can on the ProHeart6 shot. My boxer had the shot exactly 4 weeks ago. She is 6 years old, overweight to begin with, but since the injection she has been very lethargic, thirsty, and weak. I took her into the vet this morning, the soonest I could after hearing about the recall. My vet said that he feels her reaction is not to the shot, but that she is overweight and may have diabetes?? I feel this is NOT a coincidence, but he feels it is. He wanted to put her through 250.00 worth of blood tests for diabetes and thyroid problems. I refused. I still feel in my heart that her problem stems from the injection. Now that I have read the stories I fear for her life. What are people to do, when the vet doesnt believe this is the problem??
Thanks Ron for the information.

Shaggy had received the Proheart injection in the past - but his last shot was 11 months ago. I had switched back to the pills because of information I had read on the internet about the injections.

Any updates would be appreciated.
Just wait.
Nature will heal most problems if you give it a chance. Dog's are very resilient.
My dog also went into shock after giving her some sort of heart worm preventative, but it was not ProHeart 6. It was that topical one. It took her almost 9 months to recover. I took her off the steroids and stuff the vet put her on (5 months afterwards), and she started to recover much faster.
Vets and Doctors do not know everything.
And neither do we. We just do our best and live with the consequences.
No need to feel guilty.
My happy and healthy nine year old sheltie was given ProHeart 6 during a routine health exam. A few months later he became lethargic, had loss of appetite, had diarrhea and loss of bladder control. He progressively got worse and his vision and hearing seemed to go. He died in the car on the way to the animal hospital. The other dogs in the house are well and did not receive this injection.


AleciaBonwit@yahoo.com
proheart saved My dogs lives.
My hunting beagles, are great rabbit dogs and sell for $300 each.
We are in the woods and swamps all the time never had heart worm...
One "poncho" did have a adverse reaction.
I called the vets at proheart,1-800-477-1365. they told my vet
exactly what blood test to do and how to save him. Now he did have

a rough time, but with prohearets help he made it and none of my
dogs ever got heart worm...
They did a voluntarily recall,but over 7 million doses given and
only 500 dog deaths. Of course one is too many, but more would have

died of heartworm. that's what less than 1 percent.
Info here:
http://www.dvmnewsmagazine.com/dvm/article/articleDetail.jsp?id=152659

And the risk is good odds, I don't understand it all but"Since
launch in 2001 through August 2004, the overall rate of reports for

ProHeart 6 has been calculated at approximately 3 unfiltered
reports for each 10,000 doses sold. Independent data from one of
the most comprehensive databases available in the U.S. indicates a
reporting rate of 4 reports per 10,000 doses actually administered
to dogs. "
http://www.petresource.com/articlesofinterest/proheart6recall.html
I suspect there is more risk in crossing the street than in
proheart.
The rate of anaphylactic reactions has decreased from 2.2 per
10,000 doses in May 02-April 03 to 0.85 per 10,000 doses in May 03-
April 04. In addition, there has also been a decrease in the
"illness" category of reports from 2.1 per 10,000 doses to 0.98 per

10,000 doses, which supports the premise that many of the illnesses

reported (vomiting, diarrhea) were allergy related.

One of my dogs had a problem over 3 years and proheart was there to

help pull him through. And we spend alot of time in the woods.
Proheart has my support.
I do love my dogs and proheart has protected them.

bob
Bob,

That is great that your dog pulled through, but why take the risk in using Proheart when there are other heartworm preventatives that will equally help a dog with no risk? Out of 7 million doses, how can you say "only" 500 dog deaths. One is too many IMO. And how many of those 7 million actually got sick but were lucky enough to be treated by their vet to survive. Plus since the drug is relatively new on the market, who's to say that there won't be some type of long term effect by using each year when your dog becomes a senior? Especially since it effects muscle function or may seem like an auto-immune disease.

Here's a link from this forum to a couple of people that experienced side effects from Proheart http://www.oes.org/page1/proheart.html

Sorry, but of course Proheart helped you. They are making an attempt at desperate spin control to repair the damage that their product has already done. And yes, it's a product to them, medicine to us.

As for me, I'll stick with Heartguard.
US senator says Wyeth targeted FDA reviewer on dog meds
17 Nov 2005 22:46:16 GMT

Source: Reuters

By Lisa Richwine

WASHINGTON, Nov 17 (Reuters) - Drugmaker Wyeth <WYE.N> tried to discredit a Food and Drug Administration scientist who linked the company's withdrawn heartworm treatment to the deaths of hundreds of dogs, a U.S. Republican senator charged on Thursday.

Senate Finance Committee Chairman Charles Grassley said the FDA employee, Victoria Hampshire, approached his staff "because she was scared and felt unfairly targeted by Wyeth and her agency for simply doing her job."

Wyeth staff met with then-FDA Commissioner Lester Crawford a year ago and alleged that Hampshire had "personal and financial conflicts of interest" related to her review of the heartworm drug Proheart 6, Grassley said in a Senate floor speech.

The Iowa Republican said Wyeth "succeeded in having Dr. Hampshire removed from reviewing its drug."

The FDA launched a criminal investigation of Hampshire but took no action and eventually rewarded her for her work on the drug, Grassley said, adding that agency staff had briefed his committee on the matter.

A Wyeth spokesman had no immediate comment, and an FDA spokeswoman did not immediately respond to a request for a response to Grassley's charges.

Hampshire did not reply to an e-mail asking for comment, and she could not be reached by phone.

Grassley said he sent Wyeth a letter on Thursday asking the company for information and documents related to its investigation of Hampshire and comments by a Wyeth salesperson who "attempted to discredit Dr. Hampshire in the veterinary community."

Wyeth voluntarily pulled Proheart 6 from the U.S. market in September 2004, after thousands of reports of serious side effects, and the death of 600 dogs.

Grassley has been a vocal critic of the FDA and its relationship with the pharmaceutical industry. His committee has investigated the agency's oversight of several medicines, including Merck & Co. Inc.'s <MRK.N> withdrawn arthritis pill Vioxx.

He said the Wyeth case is another example of a company "that appears too cozy with the FDA."


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