Special Report (June
9, 2006)
Opinion
Pet owners can report adverse drug events
By Kelly J. Kaczala
Press News Editor
Despite rigorous clinical
trials required by the Food and Drug Administration’s Center
for Veterinary Medicine (CVM) to prove an animal drug’s
safety and effectiveness, potential side effects of drugs may
not be obvious until after the drug has been approved and widely
used, according to the CVM.
Pet owners are encouraged
to report suspected Adverse Drug Events (ADE) to the CVM, where
the information is processed. The CVM established a hotline to
report ADEs at 1-888-FDA-VETS ().
The Division of Surveillance
is responsible for consolidating all ADE reports, necessary referrals,
consultations, and preparation of summary reports, according to
Linda Grassie, communications director at the FDA.
Pet owners can also
report ADEs by obtaining a 1932a “Veterinary Adverse Experience,
Lack of Effectiveness or Product Defect Report,” from the
CVM, a pre-addressed, prepaid postage form which can be completed
and dropped in the mail. To obtain the form, write to ADE Reporting
System, Center for Veterinary Medicine, U.S. Food & Drug Administration,
7500 Standish Place, Rockville, MD .
The division, said
Grassie, uses a modified Kramer scoring system to “score”
ADEs. In the CVM system, each sign is separated from other signs
and scored according to previous experiences with a drug, 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.
“Vets in the
Division of Surveillance analyze the data provided to classify
the suspected report as remotely drug related, or as possibly,
probably or definitely related to the drug,” she said.
To help the agency
accurately analyze information, pet owners should provide “sound
clinical information” about the animal, according to the
CVM.
“This means that
the report should preferably include a good medical history, all
other drugs the animal has been given, any recent surgical procedures,
and as much in the way of clinical findings as possible,”
according to the CVM.
“Clinical findings
include veterinary exams, clinical chemistries, complete blood
counts, urinalysis, fecal exams, radiographic results, and data
such as blood pressure, any blood pressure measurements in or
around the heart, and neurologic assessments,” according
to the CVM. The agency will also contact the veterinarian to get
as much information as possible from medical records.
Pet owners can get
a copy of the summary after veterinarians and other experts at
the CVM have analyzed the information to determine whether the
pet had an ADE. To get a copy of the report, pet owners can request
a Freedom of Information (FOI) inquiry to the CVM at: FDA, FOI
staff, HFI-3556000 Fishers Lane, Rockville, Maryland.
ADE reports have increased
from 1,011 in 1992 to 9,731 in 1999, according to the FDA. Most
ADEs are underreported, estimated at only one percent.
Questions regarding
ADE reporting can be addressed to: Center for Veterinary Medicine,
Division of Surveillance, HFV-210, 7519 Standish Place, Rockville,
MD 20855, or call 1-888-FDA-VETS (). For more information,
visit the CVM’s website at www.fda.gov/cvm.
Veterinarians are not
required to report ADEs to the CVM, though drug manufacturers
are. To report an ADE to Pfizer Animal Health, which manufactures
Rimady (carprofen)l, call ; Boehringer Ingelheim
Vetmedica, Inc., which manufactures Metacam (Meloxican), call
, or ; Novartis Animal Health, manufacturer
of Deramaxx (Deracoxib), call ; Wyeth-Fort Dodge
Animal Health, maker of EtoGesic (Etodolac), call ;
Merial, maker of Previcox (Firocoxib), call ; and
Schering-Plough, maker of Zubrin (Tepoxalin), call .
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