The Compendium March 1997
THERAPEUTICS IN PRACTICE
Extralabel Drug Use in
Veterinary Behavioral Medicine
Barbara S. Simpson, PhD, DVM
The Veterinary Behavior Clinic
Southern Pines, North Carolina
Victoria L. Voith, DVM, PhD
Pet Behavior
Dayton, Ohio
D
rugs that have been
approved by the U.S.
Food and Drug Ad-
ministration (FDA) for the treat-
ment of human psychiatric dis-
orders are increasingly being
used by veterinarians for the
treatment of animal behavior
problems. Such use, however,
is extralabel. Extralabel drug
use is the “actual or intended
use of a new animal drug in a
manner that is not in accor-
dance with the drug labeling.”1
Using a veterinary drug la-
beled for treatment of one vet-
erinary medical condition to
treat a different veterinary con-
dition (e.g., a behavior prob-
lem) is one type of extralabel
use. Using a drug labeled for
treatment of a human condi-
tion, such as depression, to
treat an animal problem, such
as aggression, is another type
of extralabel use.
Regulatory Guidelines
Extralabel use of drugs is
common in veterinary medicine.
V
At referral centers, over 50%
of the prescriptions may be extra-
label.1 Until recently, veterin-
arians made extralabel drug
prescriptions under two FDA
Compliance Policy Guides 2
administered by the FDA’s Cen-
ter for Veterinary Medicine.1
The Policy Guides exercised
regulatory discretion over the
Food, Drug and Cosmetic Act.
Compliance Policy Guide #7125.06
regulated extralabel use of vet-
erinary drugs in animals. Com-
pliance Policy Guide #7125.35
regulated the distribution and
veterinary use of drugs ap-
proved for use in human
medicine. The latter guide stat-
ed that veterinary practitioners
may normally consider the use
of human-labeled drug prod-
ucts in non–food-producing an-
imal practice without the threat
of FDA enforcement actions. In
rare circumstances (e.g., when
the health of the treated animal
is harmed), the FDA might con-
sider regulatory action or (more
likely) refer the matter to the
state veterinary licensing au-
thority for investigation.2
The regulations with regard
to extralabel drug use changed
according to the Animal Medic-
inal Drug Use Clarification Act
of 1994 (AMDUCA, Public Law
103-396). The new act, which
has been in effect since late
1996, supersedes the previous
Policy Guides and permits vet-
Small Animal
erinarians to prescribe (under establish the conditions for
the guidance of the FDA) human the use or intended use of
and animal drugs in an extrala- the drug in animals.
bel manner for their patients.
Thus, responsible extralabel At present, the details of these
drug use, which was previously regulations are under advise-
regulated by Policy Guides, is ment by the FDA’s Center for
now regulated by law.3,4 Veterinary Medicine.
■ The Animal Medicinal Drug Use Clarification
Act (AMDUCA) has now taken effect.
■ The prescribing veterinarian is still responsible
KEY POINTS
for the safe use of the drug, including adverse
drug effects, and for determining that the effica-
cy of a drug exceeds its risk.
■ The establishment of a good veterinarian–
client–patient relationship is crucial for protect-
ing the veterinarian against legal liability in vet-
erinary behavior cases.
AMDUCA permits extralabel This permission to use FDA-
use of FDA-approved human approved human drugs does
drugs under the following con- not mean that the veterinarian
ditions3,5: can prescribe human psychi-
atric drugs with impunity. The
■ The drug is used by or on prescribing veterinarian is still
the lawful written or oral responsible for the safe use of
order of a licensed veteri- the drug, including adverse
narian. drug effects, and for determin-
ing that the efficacy of a drug
■ The drug is used within the
exceeds its risk.4,6
context of a veterinarian–
client–patient relationship. Safety and Efficacy Data
■ The use is in compliance Obtaining scientific evidence
with regulations promulgat- that a drug will be safe and ef-
ed by the Secretary of Health fective is a particular problem
and Human Services and for veterinary behaviorists. Few
adopted by the FDA Center of the human psychotropic
for Veterinary Medicine that drugs have been well studied
Small Animal The Compendium March 1997

sources include specialty meet- blood count and chemistry pro-

SOURCES OF INFORMATION ON ings, specialty newsletters, or file. Other data may be indicat-
VETERINARY BEHAVIORAL MEDICINE network specialty groups (see ed for specific conditions. For
Sources of Information). example, a urinalysis is often
American Veterinary Society of Animal Behavior indicated for urine elimination
Dr. Laurie Martin, Secretary-Treasurer Minimizing Legal Risk disorders. An electrocardiogram
201 Cedarbrook The uncertainty associated may be indicated when tricyclic
Naperville, IL 60565 with the extralabel use of psy- antidepressants are used. If rec-
chotropic medications makes ommended services are de-
Animal Behavior Consultant Newsletter the establishment of a good clined, this should be docu-
Department of Psychology veterinarian–client–patient mented in the medical record.
Mercer University relationship crucial as protec-
1400 Coleman Ave. tion from legal difficulties if ad- Aggressive Animals
Macon, GA 31207-0001 verse effects arise.6 At the very Because of the risk of injury
least, the veterinarian should do to humans, the management of
For more information, visit the homepage of the FDA’s the following: aggressive animals requires
Center for Veterinary Medicine: http://www.cvm.fda.gov special consideration. 6,8 The
■ Perform a complete medical veterinarian must assess whe-
and behavioral assessment ther the animal’s owner is re-
of the patient before making sponsible and evaluate the risk
any extralabel prescription. for serious injury. A veterinarian
MINIMIZING RISK OF LIABILITY treating an aggression problem
IN VETERINARY BEHAVIORAL ■ Communicate well with the
is expected to have sufficient
PHARMACOTHERAPY client and document in the
training and experience to make
medical record that the
client understands the risks these assessments. These
■ Establish a good veterinarian–client–patient assessments are particularly
of the treatment.
relationship. important when aggressive ani-
■ Assess the health of the patient with a physical ■ Be readily available to the mals are being treated pharma-
examination and appropriate screening tests. client if adverse reactions cologically. 6 If, during treat-
arise or the treatment fails. ment, a dog bite seriously
■ Assess the client for drug-abuse potential.
injures a person, it may be diffi-
■ Know the drug being prescribed, including its side
Documenting that the client un- cult to determine whether the
effects, drug interactions, and the available literature
derstands the risk inherent in incident occurred because of
documenting its veterinary use.
any extralabel use of medica- or despite the medication.8
■ Discuss potential risks, including side effects and tion is particularly important Other legal considerations
treatment failure, with the client before therapy. when human psychotropic may complicate treatment. For
■ Document the conversation by requiring the owner to drugs are used in veterinary be- example, there are some theo-
sign a combined consent form and waiver. havior medicine because there retical reasons9 and some re-
■ Recommend specific precautions to prevent human has not been much clinical vet- ported clinical data10–12 for con-
injury from aggressive animals. erinary experience with these sidering the use of the selective
drugs. A signed written consent serotonin-reuptake inhibitor flu-
form for the use of psychotrop- oxetine (Prozac®—Dista) for
for the treatment of behavior cases. Thus, attempts to pro- ic drugs is recommended.6,7 the treatment of some types of
problems in small animals. Be- vide documented information Veterinarians can take sever- canine aggression. However,
cause of the shortage of dou- may tend to enhance consen- al steps to minimize the risk of the widespread public miscon-
ble-blind, controlled studies, ar- sus based on few data. liability when using human psy- ception associating the human
ticles in the veterinary literature Although the expanded inter- chotropic medications for vet- use of this drug with violent be-
tend to repeat recommenda- est in behavior therapy has led erinary behavior cases 6 (see havior13 increases the potential
tions that were published in to increased access to infor- Minimizing Risk of Liability). An legal risk associated with pre-
other articles—recommenda- mation, other sources of more appropriate data base for as- scribing such treatment and
tions that often were based on up-to-date information are rela- sessing the patient’s physical increases the necessity for
extrapolations from human for- tively inaccessible to the veterinar- condition should be obtained. careful case selection and man-
mularies or a few unpublished ian in general practice. These This may include a complete agement.
The Compendium March 1997
Summary
In combination with tradi-
tional therapies, the extralabel
use of human psychotropic
medications offers an exciting
new option for the treatment of
animal behavior problems.
However, the veterinary practi-
tioner must be aware of current
regulations for extralabel drug
use and use good judgment in
case selection. Because of the
intricacies of selection and use
of psychotropic drugs, the vet-
erinarian should consider refer-
ring complex cases to a veteri-
nary behavior specialist.
Acknowledgments
We thank Dr. James F. Wil-
son and Dr. Charles Farho for
their comments.
References
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3. Pub L No. 103-396, § 340.
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