The primary purpose for maintaining
the FDA/CVM ADE database is to provide 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.
It is important to remember certain caveats when using
data from the FDA/CVM ADE database:
1. For any given ADE report, there
is no certainty that the suspected drug caused the
adverse event. This is because veterinarians and
animal owners are encouraged to report all suspected
ADEs, not just those that are already known to be
caused by the drug. The adverse event may have been
related primarily to an underlying disease for which
the drug was given, to other concomitant drugs,
or may have occurred by chance at the same time
the suspect drug was administered.
2. Accumulated ADE reports should not be used to
calculate incidence rates or estimates of drug risk.
Data Collection
The reporting of ADEs by veterinarians and animal
owners is voluntary. Reports may sent directly to
the FDA/CVM ("Direct" reports), to the drug
manufacturer ("Manufacturer" reports), or
to 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.
Analysis of Data
The Division of Surveillance (HFV-210) is responsible
for consolidation of all drug experience reports,
necessary referrals and consultations, and preparation
of the summary reports.
The Divisions’ ADE scoring system uses a modified
Kramer scoring system (Keller et al., Vet Clin North
Am, Food Anim Pract, March 1999,15(1):13-30). In this
system, each sign is separated from the other signs
and scored according to previous experience with the
drug, alternative etiologic candidates (other causes),
timing of the event, whether there was an overdose,
whether the reaction continued or subsided with withdrawal
of the drug, and whether a reaction recurred on re-introduction
of a drug.
Therefore, the scores are most accurate when there
is sound clinical information about an animal. This
means that the report should preferably include a
good medical history, all concomitant drugs the animal
has been given, any recent surgical procedures, and
as much in the way of clinical findings as is possible.
Clinical findings would include veterinary exam, clinical
chemistries, complete blood counts, urinalysis, fecal
exams, radiographic results, and hemodynamic data
such as blood pressure, any other pressure measurements
in or around the heart, and neurologic assessments.
Additional information on the criteria and responsibilities
for the consolidation, screening, review, and evaluation
of drug experience reports is further detailed in
the CVM Program Policy and Procedures Manual section
1240.3522, Review and Evaluation of Drug Experience
Reports.
Glossary of Terms
Died
Total number of animals represented in ADE reports
that died.
NOTE: Not all animals that died were necessarily
associated with an adverse experience that was subsequently
determined as "possibly" drug related.
Number
Number of submitted ADE reports that contained this
specific clinical manifestation.
NOTE: Not all clinical manifestations represented
in this total were necessarily determined as "possibly"
drug related.
Percent
Percent of submitted ADE reports that contained this
specific clinical manifestation. Denominator is total
number of ADE reports submitted for category of (1)
drug; (2) species; and (3) route of administration.
Reports are ONLY represented that included at least
one adverse experience that was determined as "possibly"
drug related. Numerator is number of submitted ADE
reports that contained this specific clinical manifestation.
NOTE: The clinical signs represented were not necessarily
uniformly determined as "possibly" drug
related.
Reacted
Total number of animals represented in ADE reports
that exhibited a drug-associated adverse experience.
NOTE: Not all animals that reacted were necessarily
associated with an adverse experience that was subsequently
determined as "possibly" drug related.
Reports
Total number of ADE reports submitted for category
of (1) drug; (2) species; and (3) route of administration.
Reports are ONLY represented that included at least
one adverse experience that was determined as "possibly"
drug related.
Sign
Description of reported adverse experience or clinical
manifestation associated with drug use.
Treated
Total number of animals represented in ADE reports
that were treated with the drug.
NOTE: The treated animals may or may not have exhibited
a drug-associated adverse experience.
Adverse experiences are listed by generic drug name.
Web page updated by mdt, January 27, 2004, 10:30 AM ET
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