proheart 6 - more information


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rottnbully avatar image

proheart 6 - more information

i know someone brought up the injection before, and my opinion was that i would not use it. i thought i would give some more information, for those who care to read some
i understand how many doses were sold, and reactions are a small fraction of what was used. but i still do not take this lightly, as the medication is in the dogs system for 6 months...what do you do then?? i know reactions can happen with the monthly preventatives as well, but those are only in the system for 24 hours. to me, the risk is just too great to take a chance.

i am not looking to argue, i am just posting some information and my opinion (again) LOL

here is a letter, sent by fort dodge (makers of proheart 6) to veterinarians who purchased the product:

------------------------------------------------------
Fort Dodge Animal Health Steve Connell, DVM
Division of Wyeth Director
9401 Indian Creek Parkway Professional Services
Suite 1500 (800) 533-8536
Overland Park, KS 66210

July 22, 2002

Dear Doctor:

Thank you for purchasing ProHeart 6 (moxidectin), Fort Dodge Animal Health’s
innovative product for six-month protection against heartworm infection in
dogs. The purpose of this letter is to provide you with some new information
regarding a recently approved label indication for ProHeart 6, as well as a
review of the adverse events that have been reported for the product during its
introduction into the marketplace. This update on the performance of ProHeart 6
reflects our desire to share information that has been learned about the
product after its first year on the market.

ProHeart 6 was launched in June 2001 with an indication to prevent canine
heartworm disease caused by Dirofilaria immitis for six months, and to treat
existing larval and adult stages of the canine hookworm, Acylostoma caninum. As
a result of ongoing research on the product, the Center for Veterinary Medicine
(CVM) recently approved an additional label indication for ProHeart 6,
treatment of existing larval and adult stages of canine hookworm, Uncinaria
stenocephala. The addition of U. stenocephala to the ProHeart 6 label broadens
the protection provided against canine hookworm infection, and results in a
product that more closely meets the needs of practicing veterinarians.

Along with the new indication, a second label change will appear in the
“Adverse Reactions” section of the product labeling, and is based on the
reporting patterns received from the field. With over six million doses of
ProHeart 6 (moxidectin) sold during the first year, we have seen a number of
reported reactions that were not seen in pre-approval clinical studies. This is
typical in cases of a new product after introduction to a wide population base.
Through our work with CVM, a new label statement has been approved for ProHeart
6 describing our post-approval experience. The new statement being added is as
follows:

Post-Approval Experience: although not all adverse reactions are reported, the
following reactions are based on voluntary post-approval drug experience
reporting: anaphylaxis/toid reactions, depression/lethargy, urticaria, and
head/facial edema. As with anaphylaxis/toid reactions resulting from the use of
other injectable products, standard therapeutic intervention should be
initiated immediately.

Since introduction, we have received and tracked reports from practicing
veterinarians regarding adverse events subsequent to the clinical use of
Proheart 6. A review of these reports is presented below and includes events
observed when ProHeart 6 was administered alone, as well as those observed when
given with concurrent medications. The numbers presented are unfiltered, as
reported to CVM, which include observations subsequently determined to be
unrelated to product administration.

During the first twelve months of product use, 105 reports of site reactions
post administration (.0016% of doses sold into veterinary clinics) have been
received. These events are predominantly swelling, pain, and/or pruritos that
are observed post administration. The vast majority are self-limiting in
nature, though selected cases have been treated with anti-inflammatories, and
in some cases, antibiotics.

A total of 946 reports of allergic responses post administration (.015%) have
been received. As with vaccines, this category represents the most frequently
reported event. Most of these reactions are mild and have responded to standard
medical intervention. Some, however, have been more severe, including a small
percentage of anaphylaxis cases. The most frequently reported effects have been
vomiting and diarrhea, followed by angioedema and/or facial swelling, urticaria
and gastrointestinal symptoms. Other less common events include ataxia,
weakness, dyspnea, pale mucous membranes, lethargy and fever.

A total of 685 reports of illness post administration (.011%) have also been
received. This category encompasses a wide variety of reports that are received
in a broad timeframe (from one day to several months) post administration.
There is overlap with the allergic events where both allergy and additional
symptoms were recorded. The most frequently reported signs have been vomiting
and diarrhea at variable time frames post administration, seizures or other
neurological signs and lethargy. Other rare, but more serious reports, include
erythema multiforme in 3 cases and autoimmune hemolytic anemia in a low number
of patients, most of whom had received vaccines concurrently.

No common predisposing factors have been identified at this time. In rare
situations, death has been associated with some of the adverse reactions listed
above. While there reactions appear to be idiosyncratic, we want to bring these
to your attention so that you may take appropriate measures in the event you
encounter one. In the case of allergic reactions, prompt therapy using standard
medical intervention (e.g. antihistamine, corticosteroids and fluids as needed;
epinephrine as deemed appropriate on an individual case basis) has been found
to be curative in most instances.

As is the case when prescribing any medication, careful examination of the dog
prior to administration, consideration of appropriate laboratory tests in dogs
that may have chronic conditions, and advice to the owner to watch for signs of
drug intolerance is good medical practice. If a drug reaction or intolerance is
suspected, examine the patient, provide the necessary supportive therapy, and
contact Fort Dodge Animal Health Professional Services veterinarians at
1-800-533-8536.

As a manufacturer of novel innovative products, we feel it is important to
provide timely information regarding label changes and current information on
post-approval experiences. Millions of doses of ProHeart 6 (moxidectin) have
been used safely and effectively during its first year in the market, and we
trust that this has been your experience as well. We will continue to provide
you with any pertinent information regarding ProHeart 6.

Thank you for your attention regarding these important issues. You are
encouraged to contact one of our Professional Services veterinarians at the
number listed above if you have any additional questions or concerns.

Sincerely,

Stephen A. Connell, DVM
Director, Professional Services
Fort Dodge Animal Health

ProHeart 6 is generally well tolerated. Use with caution in sick, debilitated,
or underweight animals. A small percentage of dogs showed mild, transient
swelling or itching at the injection site. While rare, digestive, neurological
or hypersensitivity reactions may occur. Read the attached package insert for
more information. To obtain additional information including a copy of the
product labeling, visit the website at www.proheart6dvm.com or call
1-800-685-5656.
-----------------------------------------------------

just thought everyone would like to read it, in case the vet did not warn you about the possible side effects.

liz

thank you

Thank you for posting the information. The Vet mentioned some of the side effects, but said the pills have side effects too. The benefits outweigh the risks. Spike takes various medications, and I was afraid with everything he takes daily, I'd forget to give him the monthly pill, thus for him and me, the shot worked well.

rottnbully's picture

yep i agree

i agree totally! i just posted the letter so people could be better informed about their choice. most often, vets do not warn you about the possible side effects or reactions the drug/vaccine/product can have.

your dog will most likely be fine, but for those who have dogs that are not...it would have been nice to know!!

i also think most side effects of a product are not reported at all, so the numbers would be higher.

liz

re: ProHeart

I mentioned in a post that Spike gets this. He had it once so far, would be due again in about 4 mos for either another injection or the monthly pills. He did not have any negative reactions to the injection. Nettie

Re: adverse rctn vs. side effects

I wonder how the adverse reactions percents for this shot compare to annual shots or rabies shots or kennel cough shots. For people the polio vaccine can cause polio but of coursethe percent is so low that it is considered better to vaccinate. I would guess that all shots carry a risk of adverse affects.

Kate

Thank you for the information!

n/m

adverse rctn vs. side effects

Thanks for that info, Liz. So many people think of an "adverse reaction" as being the same as "expected side effects" ... and they are NOT. This is why I have recently added a link to my e-mail signature ... this one .... http://www.srdogs.com/Pages/barks.html .
regarding Rimadyl. I know this product has given many dogs a second chance, but I recently had a terrifying experience when my Golden had a severe adverse reaction. So many people think their vet will only recommend the best, or will only recommend what is really necessary. "Listening" to our vets' advice is only a small part of making decisions for the well beign of our pets ... doing the research and asking the right questions and then making an educated decision is a BIG part of it. I'm lucky I knew what to watch for and could discontinue the meds immediatly ( her blood work is all normal ). With a long acting time release drug, a wrong decision is pretty hard to reverse. And like you, I am not saying "DON'T" ... I just want to share what I know. Thanks again, Liz.

Info

Thanks for the info. But I do think it is wise for everyone to remember-even with humane medicine all complaints, reations etc must be reported and then go on a possible side effects list! The most common shots to humans as well as to dogs do not work for everyone. So what you need to weigh is-do you take the chance. For some things like rabies etc-of course you must take the chance. For a heartworm shot there are lots of other alternitives but you have to decide what fits your lifestyle the best! Right now I give Winston monthly pills for heartworm-but I am seriously considering the shot because I have an awful time remembering to give it to him!

Just remember everything in life has side effects-some mild, some severe and even if the occurance is just once it must be posted! Think of the things you take..tylenol-advil-motrin-birth control pills-all can be deadly to someone! Where I work on of our clients diet from tylenol-it ate away at her liver! Crazy, but I haven't stopped taking it!

Just food for thought that not everything is fail proof-we are all different and things react to each of us in a different way!

KB

heartworm

It's not worth the risk to me. Thanks for the info Liz.

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