Annual Heartworm Injections Adverse Reactions

[morgan]

Rappie - they have obviously learnt from their PR disaster in the 90's when they treated breeders in an extremely shabby fashion when all those pups were dying. Or maybe they have a different standard of response to vets.

My vet's experience with the product was not anaphylactic reaction but auto-immune haemolytic anaemia, which does not respond to standard emergency care. Most dogs suffer no ill effects from this product, but that is no consolation to those owners whose dogs die.

Studies done on adverse reaction reporting find that less than 10% are reported, so if there was such a huge volume of reports, the actual figures would be scary indeed.

[evelin]

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.

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

[evelin]

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.

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."

[evelin]

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!

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.

[morgan]

Haven't looked into the 3 year protocols, as I never vaccinate after the puppy shots anyway, but this site has numerous links - you might find something in one of the aussie sites - Are Dog Vaccines Necessary?

[~Anne~]

Several things come to my attention in the links you have provided (thank you for these).

The 'adversereactions' website claims the following:

A Class I 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.

And then goes on to point out that the recall of Proheart is a class 1. This to me gives the impression this recall is serious stuff indeed.

But then, when you go into the FDA website and look at the current recalls the FDA have, and there are many class 1 recalls, it appears it isn't so scary. Of the current class 1 recalls there are;

"Mini Angel Food Pack" A class 1 recall because......

REASON

SuperTarget & Archer Farms brand Mini Angel Food cakes purchased before August 05, 2006 contain an undeclared Dried Egg White ingredient.

Serious stuff indeed I guess for those who may be allergic to egg white products but for the majority....

Or perhaps this class 1 recall;

"Kroger Garden Blend Frozen Fresh Stir Fry Vegetables, Broccoli, Sugar Snap Peas, Green Beans, Carrots, Celery, Water Chestnuts, Onions, and Red Peppers."

And the reason for this class 1 recall;

REASON

Product contains undeclared egg noodles (egg and wheat).

To me, the examples above show that there is 'internet hysteria' being used in the debate.

The second thing that occurs to me is that the most recent recalls (that were now 2 years ago) were on certain individual products of PH6 and not the entire range of the drug. They had issues with only certain batches.

I will say howver that it is disconcerting that information regarding PH12 is very limited? Even a search of the FortDodge Australian website does not trun up anything of value and I would think with all of the contraversy surrounding the use of this product that they would have more information available.

I am still absorbing the other information you supplied me and will comment later (work permitting). Thanks again for your links and info. It is all interesting reading but one thing that, to me at any rate, appears odd is that the focus for everyone is on PH6 which has never been available in Australia. As you know, we have Proheart12 and yet there appears to be limited information from both sides of the debate about this particular product.

[evelin]

Haven't looked into the 3 year protocols, as I never vaccinate after the puppy shots anyway, but this site has numerous links - you might find something in one of the aussie sites - Are Dog Vaccines Necessary?

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.

[evelin]

Several things come to my attention in the links you have provided (thank you for these).

I am still absorbing the other information you supplied me and will comment later (work permitting). Thanks again for your links and info. It is all interesting reading but one thing that, to me at any rate, appears odd is that the focus for everyone is on PH6 which has never been available in Australia. As you know, we have Proheart12 and yet there appears to be limited information from both sides of the debate about this particular product.

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?

[~Anne~]

Gives food for though, doesn't it?

Absolutely. It makes one wonder 'why' they are not allowing the focus on PH12.

Thanks again.

[evelin]

Gives food for though, doesn't it?

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.

[~Anne~]

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.

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????

[evelin]

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.

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.

[morgan]

The FDA has allowed the re-release of recalled drugs before - eg Tsyabri which causes a rare brain infection. It is being released with a "black box" warning. This of course means that any consumer that then contracts the brain infection cannot sue, as they have knowingly accepted the risk.

If Proheart is re-released in the US, a black box warning would protect the manufacturer, but would vets advise their clients accordingly?

[evelin]

The FDA has allowed the re-release of recalled drugs before - eg Tsyabri which causes a rare brain infection. It is being released with a "black box" warning. This of course means that any consumer that then contracts the brain infection cannot sue, as they have knowingly accepted the risk.

If Proheart is re-released in the US, a black box warning would protect the manufacturer, but would vets advise their clients accordingly?

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?

[morgan]

If I saw a label like that, I wouldn't touch it with a ten foot pole, would you?

Nup - but I'm still trying to get my head around an injection of nothing but vermicide being called a "vaccination"

[evelin]

If I saw a label like that, I wouldn't touch it with a ten foot pole, would you?

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

[evelin]

Several things come to my attention in the links you have provided (thank you for these).

The second thing that occurs to me is that the most recent recalls (that were now 2 years ago) were on certain individual products of PH6 and not the entire range of the drug. They had issues with only certain batches.

Hi Puggles,

Regarding the above, here is some more reading for you when you get the chance.

The reason for only partial recalls is because of plant inspections failing or product failure. Refer to the warning letter the FDA issued after a plant inspection in December 2003.

http://www.fda.gov/foi/warning_letters/g4602d.htm

Especially #5 in this warning letter: "The heat exchanger used in the Small Volume Parenteral manufacturing rooms [redacted] and [redacted] was found to be contaminating the water for injection (WFI) with bacteria. The failure investigation did not extend to reviewing the possible impact on other previously manufactured drug products."

Due to that plant inspection....there were multiple products recalled:

http://www.dogsadversereactions.com/moxide...condrecall.html

[Guest Dianne]

"morgan 15th Nov 2006 - 02:04 PM Post #93

The FDA has allowed the re-release of recalled drugs before - eg Tsyabri which causes a rare brain infection. It is being released with a "black box" warning. This of course means that any consumer that then contracts the brain infection cannot sue, as they have knowingly accepted the risk.

If Proheart is re-released in the US, a black box warning would protect the manufacturer, but would vets advise their clients accordingly?"

Coming in late here, but this warning may well protect the manufacturer, but it sure would not protect the Vet., not from me anyway.

How often do any of us see the labelling on the products our vets, inject/administer to our pets?

Me..everytime, if it is something that I am taking with me to administer, and often I have found them to be WELL OUT OF DATE. but drugs that are given "in house" like this yearly injection I doubt any of you would see it, however I am a pain and insist.

Any Vet. who failed to adequately advise me on any adverse possible reaction would pay dearly, if the product carried a warning.

[InspectorRex]

Well said Dianne

[evelin]

"morgan 15th Nov 2006 - 02:04 PM Post #93

The FDA has allowed the re-release of recalled drugs before - eg Tsyabri which causes a rare brain infection. It is being released with a "black box" warning. This of course means that any consumer that then contracts the brain infection cannot sue, as they have knowingly accepted the risk.

If Proheart is re-released in the US, a black box warning would protect the manufacturer, but would vets advise their clients accordingly?"

Coming in late here, but this warning may well protect the manufacturer, but it sure would not protect the Vet., not from me anyway.

How often do any of us see the labelling on the products our vets, inject/administer to our pets?

Me..everytime, if it is something that I am taking with me to administer, and often I have found them to be WELL OUT OF DATE. but drugs that are given "in house" like this yearly injection I doubt any of you would see it, however I am a pain and insist.

Any Vet. who failed to adequately advise me on any adverse possible reaction would pay dearly, if the product carried a warning.

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?