Download Canine NSAIDs and Client Education

Canine NSAIDs and
Client Education
An FDA Perspective
Dr. Amy Omer, Dr. Barbara Leotta, and Dr. Michele Sharkey
Center for Veterinary Medicine
The Food and Drug
Administration
The Food and Drug Administration
(FDA) is a federal agency within the
Department of Health and Human
Services.
FDA
FDA is responsible for ensuring that:
foods are safe, wholesome and sanitary
human and veterinary drugs, biological products, and
medical devices are safe and effective
cosmetics are safe
electronic products that emit radiation are safe
products are honestly, accurately and informatively
represented to the public.
Who are we?
CFSAN
CVM
CDER
FDA
CDRH
NCTR
ORA
CBER
CVM
FDA’s Center for Veterinary Medicine (CVM) is
a consumer protection organization.
We foster public and animal health by approving
safe and effective products for animals and by
enforcing other applicable provisions of the
Federal Food, Drug, and Cosmetic Act and other
authorities.
What We Do
The Center for Veterinary Medicine is
responsible for animal drug approval as
well as post-approval monitoring of
marketed animal drugs to assure
continuing safety and effectiveness.
How are veterinary drugs
approved?
Pharmaceutical companies decide, based
on marketability, need, economics, etc., to
pursue development of a drug.
CVM does not propose products or label
indications.
How are veterinary drugs
approved?
Pharmaceutical companies conduct the
necessary research to support drug safety and
effectiveness.
Data is submitted to CVM and scientifically
reviewed.
CVM determines if data demonstrates the drug
is safe and effective when used as directed on
the label.
How are veterinary drugs
approved?
Pre-approval studies for veterinary drugs
generally include fewer subjects than
those conducted for human drug
development.
How are veterinary drugs
approved?
For companion animals:
Pre-approval safety studies are almost
exclusively performed in young, healthy
animals (generally 32 animals).
Pre-approval effectiveness studies are
generally performed in healthy, clientowned animals.
How are veterinary drugs
approved?
“Pre-testing by the manufacturer and
review of the data by the government does
not guarantee absolute safety and
effectiveness of approved veterinary drugs
due to the inherent limitations imposed by
testing the product on a limited population
of animals.”
-CVM’s Adverse Drug Experience Reporting Webpage
What are NSAIDs?
Nonsteroidal anti-inflammatory drugs
(NSAIDs) reduce prostaglandins
throughout the body by inhibiting the
enzyme cyclooxygenase (COX).
Cyclooxygenase catalyzes the formation
of prostaglandins from arachidonic acid.
Kurie, J. M. et al. Clin Cancer Res 2001;7:2608-26
How NSAIDs Work
Prostaglandins have several important
functions:
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promote inflammation, pain, and fever
support the function of platelets
protect the lining of the stomach from the
damaging effects of acid
play a role in renal homeostasis
What NSAIDs Do
As a consequence,
ongoing inflammation,
pain, and fever are
reduced.
BUT …..
There is a risk of gastrointestinal bleeding,
ulcers, perforations, and in rare cases
kidney damage and liver problems.
Why talk about NSAIDs?
NSAIDs:
are the most commonly prescribed veterinary
analgesics.
account for the largest amount of Adverse Drug
Events (ADEs) reported to CVM.
Newer human NSAIDs (COX-2 selective)
have been shown to be safer on the GI
system; NOT the case in veterinary
medicine*.
* Based on CVM ADE database.
Approved NSAIDs
To date, NSAIDs for use in dogs have been
approved for two indications:
 Osteoarthritis
 Postoperative pain (ortho &/or soft tissue)
Approved NSAIDs
Consider the risk factors commonly
associated with these two populations of
patients:
Osteoarthritis→ geriatric population →
underlying concomitant diseases
(hepatic/renal disease)
Postoperative → hydration status →
potential for compromised renal function
Approved NSAIDs
Veterinary NSAIDs approved for use in dogs:
ETOGESIC (etodolac)
RIMADYL (carprofen)
METACAM (meloxicam)
DERAMAXX (deracoxib)
PREVICOX (firocoxib)
ZUBRIN (tepoxalin)
NOVOX (carprofen)
VETPROFEN (carprofen)
Recently Approved Veterinary NSAIDs
Approved NSAIDs
In the United States, there
are no veterinary NSAIDs
approved for oral use in
cats.
Cats have a reduced ability
to metabolize NSAIDs
compared to other species.
NSAIDs: Benefits
The approved NSAIDs provide
a tremendous amount of good
to our canine patients.
NSAIDs offer pain relief and
improved quality of life to many
dogs.
NSAIDs contribute to the
effective management of
postoperative pain.
NSAIDs: Risks
Risks are associated with the use of any
drug.
All veterinary NSAIDs have inherent risks.
CVM strives to promote the safe and
effective use of NSAIDs by painstakingly
crafting drug labels, including Client
Information Sheets (CISs).
CISs are intended to be dispensed to
clients with each NSAID prescription.
NSAIDs: Signs of Toxicity
As a class, NSAIDs are associated with
gastrointestinal, renal and hepatic toxicity.
The four most commonly reported adverse
events are vomiting, anorexia, depression,
and diarrhea.
Others include: gastric ulceration,
intestinal ulceration, renal failure, hepatic
failure, and death.
Adverse Drug Events
(ADEs)
Adverse drug experience is any adverse
event associated with the use of a new
animal drug, whether or not considered to
be drug related, and whether or not the
new animal drug was used in accordance
with the approved labeling. -21 CFR 514.3
Adverse Drug Events
(ADEs)
ADEs are voluntarily reported by
veterinarians, pet owners, and others to
the drug company and/or CVM.
Companies are required to report all ADEs
to CVM.
ADEs are stored in CVM's database and
analyzed by clinical veterinarians.
Why You?
Technicians often prepare drug prescriptions.
Even when clients have heard the benefits and
risks of NSAIDs from the veterinarian, hearing it
again from you will increase their understanding.
What You Can Do
Technicians can ensure that the Client
Information Sheets are included with each
NSAID prescription.
Technicians are often in charge of ordering.
Technicians can request CISs from the drug
representative or distributor.
What You Need To Know
Many ADEs may be prevented or treated
successfully through better understanding of
these drugs and good client communication.
Educate Yourself…on the safe use of NSAIDs,
the benefits/risks, and the potential ADEs.
Educate Your Clients…so they can recognize
potential ADEs, stop using the drug, and seek
immediate veterinary care.
Report ADEs associated with any drug.
Educate Yourself
Labels – Package Inserts contain
important information, including:
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Indications & Usage
Dosage & Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Post Approval Experience
Educate Yourself
Extralabel Use (ELU) –veterinarians may
prescribe certain approved animal drugs,
including NSAIDs, for use in animals that
is not in accordance with the approved
label directions, in the context of a
veterinarian-client-patient relationship.
-The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
ELU has not been tested and clients should be
informed of ELU.
Educate Your Clients
Communication is Key!
Written Communication
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Labels – Client Information Sheets:
are part of labeling for FDA-approved oral NSAIDs.
provide information written specifically for pet owners.
should be provided by pharmaceutical companies with
your drug order.
should be sent home with each NSAID prescription to
provide an easy reference for clients after they leave
your clinic.
Educate Your Clients
Communication is Key!
Verbal Communication
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Face-to-Face conversations with your clients can
reinforce the information provided to them by the
veterinarian, and included in the Client Information
Sheet.
Explain the potential benefits and risks.
Describe the signs of possible adverse reactions to
the drug.
Tell your clients what to do if they notice any of
these signs – STOP THE DRUG and CONTACT
THEIR VETERINARIAN.
REPORT
Options:
Report any ADEs to the pharmaceutical
company.

Toll-free number on the label.
Report any ADEs directly to the Center for
Veterinary Medicine if necessary.
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1-888-FDA-VETS
5 Take Home Points
1. Benefits/Risks are associated with any drug.
2. Know the signs of NSAID toxicity so you can
educate your clients. Client communication is
key.
3. Provide CIS with each NSAID prescription.
4. Problems: Stop the drug & Call your
Veterinarian.
5. Report ADEs.
Further Information
Center for Veterinary Medicine (CVM) Website:
http://www.fda.gov/cvm/default.html
Veterinary NSAID specific information:
http://www.fda.gov/cvm/nsaids.htm
Free NSAIDs Brochure: www.pueblo.gsa.gov
# 503R: Keeping Your Best Friend Active, Safe, and Pain Free
http://www.pueblo.gsa.gov/cic_text/misc/dog/treatdog.htm
Current Labels:
http://www.fda.gov/cvm/currentlabels.html
May 2008