evelin

Wouldn't it be something if it was obligatory for vets to disclose to their clients all possible adverse reactions of any drug that they administer to their clients' pets and also that manufacturers do the same with vets. Australian vets didn't get the "Dear Doctor" letters that were sent in the U.S. and Canada regarding either the re-labelling or the re-call of the 6 month injection, even though the product sold in Australia is the 12 month version of it and thus totally related to it. There was an APVMA response to the U.S. recall, posted on their website. But do vets have the time to regularly check this website (and there are vets who don't even use or know how to use computers)? My vets were unaware of the U.S. re-call (as I think are most vets in Australia...correct me if I'm mistaken). Again it seems to boil down to the statistics that I heard recently, that 70% of pet owners trust their vets without question and believe that all precautions and warnings have already been taken into consideration. A small percentage of pet owners do everything homeopathically or limit the drugs that are put into their pets and the rest don't give two hoots about the health of their animals. So in the end, if the manufacturers are playing down the adverse reactions or not telling the vets, the vets have nothing to tell their clients. If 70% of people don't ever question their vets or vets' actions, that is quite a slice of the marketing pie for the manufacturers, isn't it? I really believe that the vets should be able to work together on this, or at least want to work together on this. I know that those who stood up against the drug companies in the U.S. were given a very hard time. It is a difficult situation. Good for you, for insisting on more information. However, if you had asked your vet about the 12 month injection, would he have been able to tell you about all the adverse reactions and deaths in the U.S. and that it was taken off the market there in 2004?

Nup - but I'm still trying to get my head around an injection of nothing but vermicide being called a "vaccination" ;) I know what you mean. Very confusing

Morgan, that is a good question. One would assume that if a vet knew of a warning or caution on a product, he would discuss it with his client and point out the dangers, or perhaps not stock it at all. The Canadian caution label for the 6 month injection would most certainly make most people stop and think I'd imagine. However it is still out there on the market and people must be using it. Either the caution is not mentioned, or people are still using it despite the caution. To remind readers on this forum, here is the Canadian caution re-labelling: "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." If I saw a label like that, I wouldn't touch it with a ten foot pole, would you?

But if the active ingredient is the same, only stronger (although I haven't had time to look through the material on this myself) then how could they release it there? I would imagine that this would contravene something? I would assume that the FDA would have to be niotified of their intention and if so, they would have final say???? I agree to all you have said and I am sure there will be a great debate about this in the U.S. It will be interesting to see what the outcome is. Will try to find more out on this subject.

Absolutely. It makes one wonder 'why' they are not allowing the focus on PH12. Thanks again. I am told there is talk that the manufacturers are wanting to re-release the product in the U.S. but as the SR12 version this time. More food for thought.

You might find it interesting that when my vet requested safety information on the Proheart SR12 from Fort Dodge Australia, he was sent a 13 page article on the "Safety Profile of Moxidectin (ProHeart 6) and Two Oral Heartworm Preventives in Dogs". So you are right when you say we have limited information on Proheart 12, unless of course, it is one and the same as Proheart 6, only with 3 times the active ingredient Moxidectin in it which, according to the info on the labels, is clearly the case. Also, according to my information, PH12 was the first to be used in 2000, in trials on Australian dogs. It was only after these short trials that it was then released in the U.S. as a 6 monthly. SR12 was approved in Aust. Sep. 2000 and released in 2001. SR 6 was released in U.S. June 2001 and recalled in Sept. 2004. Gives food for though, doesn't it?

Thanks Morgan for that very infomative site. There is a great deal of reading there. Come to think of it, I will request info also from the APVMA as I'm sure they would be aware of all mooted changes.

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! I have to agree with what you say Morgan and thank you for that info. I have read that Beagles have a 30% higher tolerance to drugs than any other breed of dog. It is interesting that they are the breed mostly used for experiments. It would certainly show better results, wouldn't it? Also, do you have any more info on the C5 vaccines (and maybe others) being given every 3 years instead of annually? Some vets in N.S.W. will be doing it only every 3 years from next year on. My vet has not been made aware of this by any official body and my information came from a breeder in N.S.W. The APVMA have told me that their 2005 adverse reaction reports will be out very soon.

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; 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. Ingredients of Proheart 6: http://www.dogsadversereactions.com/moxidectin/label1.html http://www.dogsadversereactions.com/moxidectin/ddoc03.html A 2002 label from Australia is also on the website: http://www.dogsadversereactions.com/Scanned/AusLabel.pdf However please check my previous posting from yesterday for the Australian product. This came from the label/leaflet out of the ProHeart SR12 product container. This is from the existing product of the moment. I can not give you a more primary source than that. Please ask your vet to give this leaflet to you. Mine did. As for the ProHeart 6, apart from the links above, if you wanted the primary source, you will need to get it from Fort Dodge in the U.S. The links above with the ingredients are taken from the primary sources there. Puggles, regarding your comment that "the document doesn't give conclusive argument that Proheart 6 should not be used"....You'll find in letter to vets from the FDA http://www.fda.gov/cvm/proheart6091304.html "Due to the seriousness of these reports, we advise you to discontinue administration of Proheart 6 until further notice. Pet owners should be advised on appropriate alternative heartworm preventatives for their dogs." In a letter from Fort Dodge to vets: http://www.dogsadversereactions.com/moxide...04FDletter.html "Until that time, we ask you to remove the product from your inventory and cease using it." The FDA's recall of Sept. 2004: http://www.dogsadversereactions.com/moxidectin/recall.html classified it as Class 1 recall. "A Class 1 recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

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; 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. Puggles, please check my info that I sent you yesterday (13th) from the labels I have from my vet (for Proheart SR12) and from Fort Dodge for the Proheart 6. I don't know how to send it to you, as I am not very good on the computer with such things, but the phone number for Fort Dodge Australia is (02) 9899 0444 and the fax is (02) 9899 2151. Otherwise your vet would let you have the insert which shows the ingredients. As for the Proheart 6, you can find the ingredients on http://www.dogsadversereactions.com/moxidectin/label 1.html or contact the FDA direct in the U.S. http://www.fda.com As far as the VMAC presentations are concerned, regardless of how close the vote was, the product was taken off the market in 2004 and is to this day still off the market. If something is unproven, I don't care what the vote is for or against, I will just look into my dog's eyes, with the information I have, and just not let him/her have whatever drug may be in discussion. Why is it still off the market in the U.S.? Why have the Canadians put a black label caution on the product and are monitoring it closely still, as is our own APVMA here in Australia? Why was there a recall in Korea? etc. etc. etc. It is all there if you care to research it. All I can do is offer the info I have researched from official sources. I should also add that the Banfield studies that all the "yes" votes took into account, were funded in part by "grant ROI CI 000093 from the US Centers for Disease Control and Prevention, and by a CONTRACT WITH FORT DODGE ANIMAL HEALTH." That is quote unquote from the fax I received from Fort Dodge Australia after the death of our dog Tobie. I actually requested they send me information on all the studies. Therefore I did not rely on information from anywhere else. I got the info from "the horse's mouth" so to speak. I will continue to find a way to get you the primary source info for the 6 and SR12 ingredients. Please be patient as I need to find a way to send it, unless you go to the links I mentioned above. Also the APVMA would certainly give you info. Try contacting the following: [email protected] or Fort Dodge Aust. directly. (02) 9899 0444 and fax (02) 9899 2151. I sincerely hope this helps Evelin

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

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?

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

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

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

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

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

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.

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

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

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.

DEAR GINGER'S MUM, THANK YOU FOR YOUR KIND THOUGHTS REGARDING TOBIE. MY VETS HAVE READ ALL THE RESEARCH ON THESE INJECTIONS AND AFTER WHAT HAPPENED TO TOBIE WILL NOT OFFER IT TO OWNERS. IF SOMEONE WANTS IT REGARDLESS OF BEING CAUTIONED ABOUT IT, MY VETS WILL NOT GIVE IT CONCURRENTLY WITH OTHER VACCINES. THEY ARE SUGGESTING TO OWNERS THAT THEY USE THE MONTHLY TABLETS. THIS HAS ALL BEEN VERY TRAUMATIC FOR EVERYONE BUT THE POINT IS THAT MOST VETS ARE UNAWARE OF THE PROBLEMS THIS DRUG HAD IN THE U.S. OR THAT IT WAS TAKEN OFF THE MARKET THERE. THE MAJORITY OF VETS JUST DON'T HAVE THE TIME FOR THE INTENSE RESEARCH NEEDED TO LOOK INTO NEW PRODUCTS. THE INFORMATION REGARDING THE WITHDRAWAL OF THE INJECTION IS NOT INTERNET HYPE, IT CAN BE READ ON OFFICIAL RECORDS AND DOCUMENTATION. ANYONE CAN CHECK OUT THE FDA WEBSITE IN THE U.S. TO GET INFORMATION ON THE HEARTWORM INJECTION. http://www.fda.com then click on "Search the FDA...Recalls, Alerts & Warnings" then type in Proheart injection recall. THERE IS A LOT OF INFORMATION THERE AND IT IS OFFICIAL AND AVAILABLE UNDER THE FREEDOM OF INFORMATION ACT. ALSO A GOOD LINK FOR INFORMATION ON THE SENATE COMMITTEE HEARING INTO THE SITUATION IS: http://www.whistleblower.org/template/page.cfm?page_id=141 THE MOST IMPORTANT THING IS THAT PET OWNERS REPORT ANY SUSPECTED ADVERSE REACTIONS FROM ANY VET PRODUCT TO THE APVMA, OUR OWN AUSTRALIAN VET MEDICINE AUTHORITY. IT IS AS SIMPLE AS THAT. OUR PETS TRUST US.....WE TRUST OUR VETS....THE VETS TRUST THE DRUG COMPANIES. IF SOMETHING GOES WRONG, WHO GETS THE SHORT END OF THE STICK?....OUR PETS, AND ULTIMATELY WE DO TOO. THE APVMA IS THERE TO HELP US. I WOULD JUST LIKE PEOPLE TO BE AWARE AND TO BE ABLE TO MAKE INFORMED DECISIONS FOR THEIR BELOVED PETS. EVELIN

HI VANESSA, OUR DOG WAS A BORDER COLLIE. I THOUGHT I HAD ANSWERED YOU YESTERDAY, BUT IT DOES NOT APPEAR ON THE FORUM FOR SOME REASON. THANK YOU SO MUCH FOR YOUR CONDOLENCES. 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