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HEALTH: Importance of Reporting ADE's to the FDA   Message List  
Reply | Forward Message #806 of 1120 |
This also pertains to human reporting adverse effects from their own
medicines...

It is so very important to report any suspected adverse drug effect to the
FDA Center for Veterinary Medicine. Even if you only SUSPECT it -
Veterinarians ARE NOT REQUIRED to report to the FDA! It is voluntary - So
you know what that means -

The following is quoted from an FDA CVM web site:
http://www.fda.gov/cvm/index/ade/fdave98.htm

QUOTE:
The primary purpose for maintaining the FDA/CVM database is for providing an
early warning or signaling system for adverse effects not detected during
premarket testing of FDA-approved animal drugs and for monitoring the
performance of drugs not approved for use in animals. The FDA/CVM ADE
reporting system depends upon the detection of an adverse clinical event by
veterinarians and animal owners, the attribution of the clinical event to
the
use of a particular drug ("suspect" drug), and the reporting of the ADE to
the manufacturer of the suspected drug or directly to FDA. Data from these
ADE reports are coded and entered into the computerized FDA/CVM ADE
database.The reporting of ADEs by veterinarians and animal owners is
voluntary. They may send their reports directly to the FDA/CVM ("Direct"
reports), to the drug manufacturer ("Manufacturer" reports), or both. The
drug manufacturers of FDA-approved animal drugs are required by law and
regulation to submit to the FDA post-market ADE reports received by any
means
from veterinarians and animal owners.
END QUOTE

Remember, it was because of hundreds of dog owners reporting suspected ADE's
of Rimadyl to the FDA that some changes came about.

Taken from the January 2000 issue of DVM Magazine:

QUOTE:
"The FDA update states that most of the pet owners reporting ADEs said they
were not aware of the potential adverse effects associated with Rimadyl.
The
agency recommends veterinarians clearly communicate the benefits and risks
of
the product and the necessity for periodic follow-up evaluations.
END QUOTE

On June 12, 2001, the FDA published a brochure for vets emphasizing the
importance of monitoring and reporting ADEs. This is more support for the
basic goal of this list. You might find this brochure useful when talking to
vets about ADEs. Here's the link:

http://www.fda.gov/cvm/index/ade/pharmacobrochure.pdf

Just don't rely on your vet to report any ADE on their own. Many of us
have
learned to take some matters into our own hands - for the survival of our
beloved companion animals.

Jean
(Always for George - Always for the Rimadyl Dogs)

"A single voice may not be heard, but the voices of many
cannot be ignored. " ~ Author Unknown









Diana


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Wed Sep 4, 2002 6:18 pm

artemisd123
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Message #806 of 1120 |
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This also pertains to human reporting adverse effects from their own medicines... It is so very important to report any suspected adverse drug effect to the ...
Diana Artemis
artemisd123
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Sep 4, 2002
6:18 pm
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