Annual Heartworm Injections Adverse Reactions

[Mrsdog]

All my dogs have the yearly heartworm injection and have done so since it first came out. There have been no adverse reactions and believe me I watch them closely.

Must admit that I thought this was just one more thing I didn't have to worry about!

Worse than this - they have C5 at the same time.

Now you have made me think and I don't know what to do. I live in a high-risk heartworm area so have to weigh up the risks.

Perhaps having them tested twice a year would be the way to go.

I asked my Vet recently at the time of last vaccination if it was wise to give both this and heartworm at the same time and of course he said yes, or I wouldn't have had it done. This is a very caring Vet and I would trust him implicitly, but now I'm thinking perhaps he doesn't know everything.

I would never forgive myself if I caused the death of one of my dogs by making the wrong decision.

Noels.

[~Anne~]

Now you have made me think and I don't know what to do. I live in a high-risk heartworm area so have to weigh up the risks.

Perhaps having them tested twice a year would be the way to go.

If you are in a high risk area then and you feel uneasy about giving an annual injection perhaps a monthly preventative is a good alternative?

I am not sure that a bi annual test is appropriate. If something goes awry with one test or you forget to have it done then you could open yourself up to problems. Remember, treating heartworm is a serious business and the possibility of permanent damage to the heart and other organs from the treatment and from the heartworm is quite high.

On the other hand....... if you have never had any issues then why not continue with the way things are?

[Skipy]

Steve, thanks for those links, I only trust the ones that are done by scientists, so I did check those out, I also did a pubmed general search, and there seems to be a long term protection only for the core vaccines, which are in fact most, except kennel cough as far as I could find.... I will try to find others that look at plus of yearly boosters.

Mrsdog, if your dogs are fine with heartworm and booster at the same time what is the problem? I know many people that give both at the same time and their dogs could not be healthier.

One thing that I dont like about those yearly ones, and correct me if I am wrong, but the initial dose that is given must be pretty high.....

[evelin]

evelin.... you do realise that the product that was removed from the shelves in the US is not the same product available in Australia don't you?

(Psst....... to type in uppercase is considered 'shouting' on the internet and is not kosher or polite)

Hi Puggles,

Firstly, I would like to thank you for giving me that hint on internet etiquette. I am new to this and was unaware I was "shouting", so I appreciate your comment.

Secondly, the product that was removed from the shelves in the US is the 6 montly version of the one we have here. Our Australian injection has 3 times the active ingredient, Moxidectin in it. Otherwise it is the same. This information comes directly from the manufacturers. Also were you aware that the 12 monthly injection was tested on Australian dogs in 2000 before being released in the U.S. as a 6 monthly injection in 2001?

Both 6 month and 12 month injections come in two vials. Vial 1 contains moxidectin microspheres and is in powder form. Vial 2 contains a specifically formulated sterile vehicle for constitution with Vial 1. (The 2003 U.S. label states that Vial 2, the sterile diluent, contains 3.1% glyceryl tristearate, 2.4% hydroxypropyl methylcellulose, 0.87% sodium chloride, 0.17% methylparaben, 0.02% propylparaben and 0.001% butylated hydroxytoluene. Hydrochloric acid is used to adjust pH). This is actually stated in the text of the label.

The product was taken off the market the following year (2004) and remains off the market in the U.S.

In Canada it has been relabelled with the following warning: "Because of its potential for serious adverse drug reactions and the absence of identifiable risk factors associated with those reactions, ProHeart 6 is only indicated for those dogs in which alternative preventatives cannot be effectively administered."

The 6 month injection contains 3.4mg per ml. of Moxidectin microspheres.

The 12 month injection contains 10mg per ml. of Moxidectin microspheres.(3 times the amount that the 6 month injection has).

I hope this is of help to you. Incidentally, a lot of Pugs reacted to the 6 month version in the U.S. Have a look at the website I mentioned earlier in this thread:

http://www.dogsadversereactions.com

Another interesting read is the chairperson's summary of the VMAC meeting:

http://www.fda.gov/cvm/Documents/VMACWinter05Summary.doc

A question asked at the above VMAC meeting was "If there are remaining safety concerns with ProHeart 6, what additional avenues of research could be explored to mitigate and/or prevent the adverse events?

Suggestions from the panel and consultants include additional studies, both new prospective cohort and retrospective case-control studies; performance of a risk benefit analysis taking into account owner non-compliance when using oral heartworm preventives; additional clinical trials; additional pharmacokinetic trials to explore the effects of increased body temperature on release of the drug from the injection site; release of the Banfield data to the FDA for analysis; possible "black-box" labeling of the drug to emphasize the possible risks; development of more information about the drug's effects on different life stages of the parasite; meta-analysis of data collected from multiple studies or areas to increase the power of detecting and quantifying the adverse events in comparison to other heartworm preventives.

[evelin]

Mine are on the annual Revolution injection.

My vet says he has not heard of any adverse reactions and he says vets all talk about suchlike so he'd know, given how long it has been in use.

Terribly sorry about Tobie.

Dear Ginger's mum,

I was wondering about the annual Revolution injection. My vet has not heard of it. Is it very new on the market? Please let me know as I would be very interested in knowing what is in it and how it differs from the Proheart SR12 annual injection.

Thanks, Evelin

[evelin]

DEAR MORGAN

I TRULY WISH I HAD RESEARCHED THE PRODUCT BEFORE ALLOWING MY VET TO USE IT. IT WAS OFFERED TO ME INSTEAD OF THE MONTHLY TABLETS AND MY VETS BELIEVED IT TO BE SAFE. I SO REGRET MY IGNORANCE. (AND THEY TRULY REGRET THEIRS).

COULD YOU PLEASE LET ME KNOW WHAT THE HOMEOPATHIC TREATMENT IS? THANK YOU FOR YOUR COMMENTS. EVELIN

Many years ago my vet gave me the procedure for homoeopathic heartworm treatment - have since lost it, but Diana Hayes does a heartworm treatment program.

It involved using increasing strengths of Arsenicum, starting at the 6x one, over a number of weeks, followed by the Heartworm nosode. The dog had to be kept quiet, as is done with orthodox treatment, to prevent pieces of dead heartworm lodging where they shouldn't. She always used it on elderly or very unwell dogs that she felt wouldn't cope with the normal method.

Thank you Morgan for the homeopathic info. I will look into it with interest. Evelin

[evelin]

Point is but especially for breeding dogs even the monthly heart worm meds are a potential problem .

We all need to assess whether or not our own dogs are truly at risk of getting heartworm and we should be informed of the possible adverse side affects of any of the meds .We should also be able to access information on what our choices are as a normal right .

When symptoms show pretty soon after the vaccination its more obvious that we should be looking at the drugs but what of the things which may take a lot longer to show up. Thyroid problems , immune related issues, allergies etc or even lowered sperm counts wont be something thats going to be proven to be impacted on by the drugs unless different and longer studies are undertaken which are not sponsored by the drug companies .

Once the MDBA gets their nutrition research program underway we will be testing the impact of heart worm meds on a dog's health , immune system and breeding issues . This should be started around June 2007. Then hopefully around December 2007 there will be one based on how vaccinations passed the first birthday may also affect the immune system.

Its going to take us about 10 years to gather all of the data but with all 3 studies Im expecting that along the way we will be able to offer some unique resources to owners and breeders which will help them to make educated decisions.

Because we wont have any sponsorship or donations from food or drug companies funding is a consideration but it all looks like being able to go ahead and the nutritional one is guaranteed to start in the next few months. The heartworm and vaccination studies will be much easier to put together [ I hope]

Steve, this is all very exciting news for the future health of our pets. I am trying to get info on a new Rabies Challenge website and although we are free of endemic rabies in Oz and N.Z. at the moment, it would be good to see what is being done about it elsewhere. I will let you know as soon as I have the info.

[evelin]

Evelin, I am glad you had this reaction reported to the AVPMA- they are very helpful

I have Rough Collies so have know for years not to give any "mectin" based drugs to my Collies even if they Vets say they are safe.

It does not only end with Ivermectin sensitivity- if your dog is Ivermectin Sensitive( this includes Coolies Rough and Smooth, Shelties, Aussie Shepherds,Boder Collies, GSD's, Akitas, Whippets and other sighthounds) it will also not be able to have a whole lot of other drugs that are administered by most Vets.

If anyone wants the list feel free to PM me

Hi Inspector Rex,

I would love to get the list from you but don't know what "PM me" means. Could you please explain that to me, as I am new to these forums. Thanks, Evelin

[evelin]

My lab has heartworm injection for 2 years now, did not have adverse reaction.Should i stop her on this injection and give her the tablet instead? Please help.Thank you

The info I have is that MANY dogs in the U.S.A. did not react the first time, or the second or maybe even the third, but then the NEXT time, was the last time.

Have you read all the info on the injections, knowing that the 6 monthly and 12 montly are the same except that the 12 monthly has 3 times the amount of active ingredient Moxidectin in it? Please look at the following sites:

http://www.dogsadversereactions.com

http://www.thepetguardian.com/html/body_vm...ech_rogers.html

Hopefully this will help make up your mind. We all love our pets and just want what is best for them.

Evelin

[evelin]

Here's some good links on mozzies and heartworm risk the last one is about humans who were given ivermectin Scares the pants off you.

http://www.preciouspets.org/newsletters/articles/heartworm-article.htm

http://student.vwc.edu/~sldodgers/dogworm.htm

http://www.showdogsupersite.com/kenlclub/breedvet/herx.html

http://www.safe2use.com/scabiesboard/ivermectin/Ivermectin-Deaths-Scabies.htm

Hi Steve,

Have you seen the following World Health Organization link?

http://www.who.int/tdr/publications/tdrnew.../moxidectin.htm

the TDR is the Special Programme for Research & Training in Tropical Diseases with the WHO.

It is interesting to see what the final results of the moxidectin trials were:

"Final results of moxidectin trials in animal models were presented to the TDR Product Research and Development Committee in March 2000. These preclinical studies have shown that the compound fulfils the criteria for a potential macrofilaricide (i.e. a drug that kills adult filarial worms) and has unique selling points:

A single treatment produces slow death of adult worms in birds and dogs.........."

According to the manufacturer of the annual heartworm injection, it DOES NOT kill adult worms, but these final results of the moxidectin trials were in 2000 and they say that moxidectin DOES kill adult worms. These results were known BEFORE the annual injection of Moxidectin was released to the public in 2001.

What do you make of that?

Thanks for sharing all those interesting links. There is a lot of info out there if one knows where to look!

Evelin

[evelin]

Either your Vet handles the truth carelessly, or he lives in a bubble.

Perhaps there are several who live in this bubble as I have discussed this very subject with at least 4 different vets and their reactions were either that it was internet hype or they were not aware of any need to withdraw the product because of adverse reactions *shrugs*

My vet won't use it anymore after two dogs died from auto-immune haemolytic anaemia as a result of him giving them the injections. He was so shocked that he did some basic research and found that this was an established adverse reaction - he said the manufacturer states it is a 1 in 10,000 event, but he certainly didn't give 20,000 injections

As a consequence, he decided that the risk wasn't worth it, especially as he was the one who had to tell the owners that their dog was going to die. You only have to look at the manufacturers warning letter that I have posted before to see that the injection's risks are not acceptable. Obviously your 4 vets have not read this warning.

Dear Morgan,

I have not seen the manufacturers warning letter that you posted before. Would you be kind enough to post it again? I would be most interested in getting this information. Many thanks

Evelin :D

[evelin]

All my dogs have the yearly heartworm injection and have done so since it first came out. There have been no adverse reactions and believe me I watch them closely.

Must admit that I thought this was just one more thing I didn't have to worry about!

Worse than this - they have C5 at the same time.

Now you have made me think and I don't know what to do. I live in a high-risk heartworm area so have to weigh up the risks.

Perhaps having them tested twice a year would be the way to go.

I asked my Vet recently at the time of last vaccination if it was wise to give both this and heartworm at the same time and of course he said yes, or I wouldn't have had it done. This is a very caring Vet and I would trust him implicitly, but now I'm thinking perhaps he doesn't know everything.

I would never forgive myself if I caused the death of one of my dogs by making the wrong decision.

Noels.

Most vets are very caring but don't have the time to do the intensive research it takes to find out everything these is to know. They have to just trust what the manufacturers tell them (or don't tell them). My vets do not offer the injection anymore but if somebody insists on giving it to their dog, even after being cautioned by the vets, they will definitely NOT give it concurrently with any other vaccine. They are being super cautious and very responsible, and rightly so.

Do you have anything against the monthly tablets? It is easy to remember if you pick the same day of the month (e.g. 1st of each month) and it is not something that sits in your dog's body for a year. Once it is in, it cannot be taken out. Also there is talk of the annual vaccinations being done every three years instead. This is an interesting development as it seems that pets are being over-vaccinated at the moment.

Hope this info is of some help to you.

Evelin

[morgan]

Evelin - here is the link you requested -

Wyeth warning letter

[evelin]

Evelin - here is the link you requested -

Wyeth warning letter

Morgan, thank you for the manufacturers warning letter:) I know this was sent to Vets in the U.S. and Canada. Was it also sent to Vets in Australia?

[morgan]

As this is for Proheart 6, it wouldn't have been sent to Australia. You need to find a friendly vet and ask to see the insert supplied with the Proheart 12 injection if you can't find it on the net.

[evelin]

As this is for Proheart 6, it wouldn't have been sent to Australia. You need to find a friendly vet and ask to see the insert supplied with the Proheart 12 injection if you can't find it on the net.

Thanks Morgan,

I actually got the Proheart 12 insert from my vet today, so that I could quote the ingredients and compare them to the Proheart 6. I posted this info to Puggles on this forum today. I also got the revised insert which is the new approved label/leaflet for the new batches to come. The existing label states that it is recommended for use in dogs OLDER THAN 6 MONTHS, while the new approved label/leaflet states that it is recommended for use in dogs FROM 12 WEEKS OF AGE. The only precautions on both labels are:

"Do not inject suspended product intravenously."

"Use aseptic technique at all times."

"In a small number of cases, there may be short-lived pain at the time of injection or slight transient (1-2 weeks) swelling at the site of injection."

"Allergic reactions such as anaphylaxis (facial and aural swelling, urticaria, vomiting) occur rarely and may require parenteral treatment with an antihistamine, a corticosteroid or adrenalin as appropriate."

I wish I knew how to let you see these inserts. Will try and find a way to do it.

Evelin

[~Anne~]

Hi Puggles,

Firstly, I would like to thank you for giving me that hint on internet etiquette. I am new to this and was unaware I was "shouting", so I appreciate your comment.

Secondly, the product that was removed from the shelves in the US is the 6 montly version of the one we have here. Our Australian injection has 3 times the active ingredient, Moxidectin in it. Otherwise it is the same.

Thanks for this. I'll certainly look into the links you have supplied.

[morgan]

I also got the revised insert which is the new approved label/leaflet for the new batches to come. The existing label states that it is recommended for use in dogs OLDER THAN 6 MONTHS, while the new approved label/leaflet states that it is recommended for use in dogs FROM 12 WEEKS OF AGE. The only precautions on both labels are:

"Do not inject suspended product intravenously."

"Use aseptic technique at all times."

"In a small number of cases, there may be short-lived pain at the time of injection or slight transient (1-2 weeks) swelling at the site of injection."

"Allergic reactions such as anaphylaxis (facial and aural swelling, urticaria, vomiting) occur rarely and may require parenteral treatment with an antihistamine, a corticosteroid or adrenalin as appropriate."

I wish I knew how to let you see these inserts. Will try and find a way to do it.

Evelin

Sounds like the usual scenario of the US withdrawing products from the home market due to safety issues, but still flogging them off abroad to unsuspecting consumers. Was aware they specialised in doing this to third world countries, hadn't realised our station in life wasn't much higher

Fort Dodge application - this document shows that collies were monitored for 24 hours for ivermectin toxicity, 12 week old puppies monitored for up to 21 days for adverse reactions and studies on breeding dogs and bitches only appear to have been done on beagles.

IMO this study seems very limited in it's scope.

AVA response to US recall - this document shows that Proheart 12 was not recalled here after the Proheart recall in the US by the same manufacturer due to the lack of adverse reaction reports. Clicking on the links contained and checking on reaction reports for Proheart 12 here shows 90 reports in 2003 of which half were described as "probable". As adverse reaction reports are found by studies to be less than 10% of the actual number in all countries, the APVMA is being very circumspect in it's recommendations. How many owners take their dogs back to the vet for every single reaction? How many vets actually acknowledge these as reactions to the injection, and of these, how many actually report them?

Fort Dodge has a very bad reputation in this country, in the 90's there were many litters and part litters lost after using their products - usually within a week. Many breeders were given very short shrift by Fort Dodge, despite running up massive vet bills trying to save their dying puppies. My vet has not touched any of their standard vaccines since. Unfortunately I think they now have the monopoly on C5 in this country (have heard they supply the bordetella component to other manufacturers, but have not checked this). They are not referred to as "Fort Dodgy" for nothing!

[~Anne~]

Another interesting read is the chairperson's summary of the VMAC meeting:

http://www.fda.gov/cvm/Documents/VMACWinter05Summary.doc

Hmmmmm............ again.... the document doesn't give conclusive argument that Pro-heart 6 should not be used. After all of the presentations were made the question was asked:

Based on the presentations and information provided is ProHeart 6® safe for use in dogs? Yes or No

There were 7 experts who said 'Yes' it is safe to use and 8 who said 'no' it is not safe to use.

It also states the following when qualifying the responses given;

(It should be noted that almost all of the responses to the first question were qualified with a concern that more information and data were needed to establish the safety or the risks associated with the use of ProHeart 6®.)

evelin - I have spent some time perusing the 'dogsadversereactions.com' site and can not find any link to the active ingredients of Proheart 6 or 12. Are you able to direct me? I need it to be a primary source.

[Rappie]

Unfortunately I think they now have the monopoly on C5 in this country (have heard they supply the bordetella component to other manufacturers, but have not checked this). They are not referred to as "Fort Dodgy" for nothing!

Fort Dodge produce their own C3/C4/C2i etc vaccines, but the BB component is made by Pfizer.

I have actually had quite a long discussion with one of the techincal services vets from Fort Dodge, after reporting an adverse experience. Although their responses were carefully worded, I was reasonably satisfied with the outcome. The Proheart 12 injection is being monitored carefully by the APVMA and it will be reviewed if the adverse experience reports indicate that this should be done. However, because the reports can be submitted by any one, at any time, and because vaccines are often administered at the same time, it is difficult to determine a direct causal link to many of the experiences reported. That doesn't mean that they don't happen, it means it's difficult to prove it. The majority of the adverse events are anaphylactic reactions, which can happen as a reaction to anything (bee stings, any other drug) but which can be treated effectively with prompt veterinary treatment. I gathered from my discussion that part of the reason for the recall in the US was the sheer volume of reports, where each one must be counted even if it were highly unlikely to be related to the use of the product.