Please
keep in mind - According to the FDA:
"In
common terms, an adverse drug experience (ADE) is either
an undesired side effect, or the lack of a desired effect.
The Center for Veterinary Medicine (CVM) defines an
ADE as 'any side effect, injury, toxicity, or sensitivity
reaction (or failure to perform as expected) associated
with use of an animal drug, whether or not determined
to be attributable to the drug.' " (This means
that you need only SUSPECT that the side effect is caused
by the drug; you do not have to prove it.)
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Steps to Take If You
Suspect Your Dog Has Had an Adverse Reaction
(1) If you see any of the listed signs of
adverse reaction to a drug, immediately take your dog to
the vet. The earlier your
dog gets appropriate treatment, the better the chances of
complete recovery.
(2) Have the vet do a blood panel and CBC (complete
blood count). This will help your vet to determine
the supportive therapy your dog needs.
(3) If you cannot get an immediate appointment with
your vet, go to the nearest emergency veterinary clinic
if your dog seems seriously ill. Explain that you
believe your dog is having a reaction. If the clinic staff
is unfamiliar with the potential side effects, have them
refer to the product description or package insert. Misdiagnosis
is frequent in cases of drug adverse reactions. Do NOT accept
a quick diagnosis, until an adverse reaction has been thoroughly
ruled out.
(4) Ask your veterinarian to call the drug manufacturer.
The staff of veterinarians at the drug manufacturer should
be able to offer guidance to your veterinarian for the necessary
tests, medications and therapy your dog may need.
(5) Try to maintain a diary of the
events leading up to your dog's suspected adverse drug reaction.
Using as many details as you remember.. Obtain all medical
records from all sources. Your diary and these records will
become invaluable, should you decide to apply to the manufacturer
for reimbursement of veterinary medical expenses.
(6) Don't Panic!! You won't be able to
help your dog or yourself if you do.
(7) Call or have your veterinarian
call the FDA's Center for Veterinary Medicine to report
the incident. Report to the FDA either by telephone
at: (or 1-888-FDA-VETS)
or: You may also report an adverse drug experience using
a form that is available on the FDA website. Access to the
form is at http://forms.psc.gov/forms/FDA/fda-1932a.pdf
Just print out the form, complete it and mail it. It is
two-sided and postage paid.
If you decide to report
an ADE , the FDA advises as follows:
"You should first
call the drug company. Inform them that you wish to
report an ADE, and ask to speak to a technical services
veterinarian. The technical services veterinarian
should ask a series of questions about the experience,
complete a form called the FDA 1932, and forward the
report to CVM . We suggest the drug company as your
first point of contact because many companies will
also offer clinical advice or diagnostic assistance.
CVM does not provide these services. If you wish to
confirm that your report was forwarded, or prefer
not to call the drug company, call CVM directly at
(888) FDA-VETS. Please ask to speak to one of the
veterinarians responsible for the ADE monitoring program."
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If it becomes necessary to establish whether a drug was a
factor in a dog's death, a necropsy must
be performed. The necropsy does NOT have to be done by a veterinarian
appointed by the manufacturer; it should, in fact, be done
by an impartial third party. However, the manufacturer should
be advised promptly that the necropsy is being undertaken
and that they will be entitled to some, but not all, of the
tissue samples obtained.
Please Note:
If you do not want your information released to anyone to
check the box next the the space for veterinarian's name and
address.
Report to FDA Form 1932A
http://forms.psc.gov/forms/FDA/fda-1932a.pdf
Temporary Link for form 1932A
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1932a.pdf
FDA Reporting
FAQ
FDA
Form 1932A on DogsAdverseReactions
If you do not file a complaint
with the FDA.....
you're giving the manufacturer ammunition to use against
you.
They can then claim there are so few cases of adverse
reactions.... nothing needs to be done.
When you don't file, you stack the statistics in the
manufacturers favor.
Don't depend on your vet's office.
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How
CVM Uses Adverse Drug Experience Reports System
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