1. Canine NSAIDs—What Dog Owners Should Know
An FDA Perspective
Dr. Carmela Stamper
FDA Center for Veterinary Medicine

2. FDA Center for Veterinary Medicine
FDA’s Center for Veterinary Medicine (CVM) is a consumer protection organization.
CVM regulates
animal drugs (approval and post-approval monitoring)
animal feeds (including pet foods and treats), and
animal devices.

3. How are veterinary drugs approved?
Drug companies conduct the necessary research to support drug safety and effectiveness.
Study data are submitted to CVM for scientific review.
CVM determines if data demonstrate the drug is safe and effective when used as directed on the label.

4. How are veterinary drugs approved?
Pre-approval studies for veterinary drugs are smaller and have fewer subjects than human drug studies.

5. How are veterinary drugs approved?
For companion animals (like dogs, cats, and horses):
Pre-approval safety studies are almost always conducted using young, healthy animals (generally 32 animals).
Pre-approval effectiveness studies are generally performed in healthy, client-owned animals.

6. What are “NSAIDs”?
Nonsteroidal anti-inflammatory drugs (NSAIDs) decrease the prostaglandins in the body by inhibiting the enzyme, cyclooxygenase (COX).
Cyclooxygenase catalyzes the formation of prostaglandins from arachidonic acid.

7. How NSAIDs Work Prostaglandins perform several
important jobs, including:
promoting inflammation, pain, and fever
supporting platelet function
protecting the stomach lining from stomach acid
maintaining normal kidney function

8. What NSAIDs Do NSAIDs help reduce inflammation, pain, and fever… BUT…
they also carry risk of gastrointestinal bleeding, ulcers, perforations, and rarely, kidney or liver damage and death.

9. Why talk about NSAIDs?
most commonly prescribed veterinary pain relievers, and
account for the largest number of Adverse Drug Events (ADEs) reported to CVM.
Newer “COX-2 selective” NSAIDs shown to be safer on human GI system but NOT so in veterinary medicine*.
* Based on CVM ADE database.

10. Approved NSAIDs So far, NSAIDs for dogs approved for two indications:
Osteoarthritis
Postoperative pain (after orthopedic and/or soft tissue surgery)

11. Approved NSAIDs Risk factors commonly associated with these
two groups of patients:
Osteoarthritis→ older dog population → can have other diseases at same time (like kidney or liver disease)
Postoperative pain → hydration status → if dehydrated before, during, or after surgery, potential for kidney problems

12. Approved NSAIDs Approved Veterinary NSAIDs for dogs:
ETOGESIC (etodolac)
RIMADYL (carprofen)
METACAM (meloxicam)
DERAMAXX (deracoxib)
PREVICOX (firocoxib)
ZUBRIN (tepoxalin)
NOVOX (carprofen)
VETPROFEN (carprofen)

13. Approved Dog NSAIDs

14. NSAIDs and Cats
NO veterinary NSAIDs approved for long-term use in cats in US
Cats can’t break down NSAIDs as well as other animals

15. NSAIDs: Benefits Approved NSAIDs help our canine friends by
giving pain relief and improved quality of life to many arthritic dogs, and
helping manage post-surgery pain.

16. NSAIDs: Risks
Risks are associated with use of any drug, including veterinary NSAIDs
CVM promotes safe and effective use of NSAIDs
Package inserts
Client Information Sheets (CISs)
Owners should get CIS with every NSAID prescription (but not required in every state)—ask for one

17. NSAIDs: Signs of Toxicity
NSAIDs are associated with gastrointestinal, kidney, and liver toxicity
Most-commonly reported adverse drug events: vomiting, anorexia, depression, and diarrhea
Other adverse drug events: stomach ulcers, intestinal ulcers/perforation, kidney and liver failure, and death.

18. Adverse Drug Events (ADEs)
Voluntarily-reported by veterinarians, pet owners, and others to drug company and/or CVM
Companies required to report all ADEs to CVM
CVM stores ADE reports in database
CVM veterinarians analyze all ADE reports

19. Report ADEs Report ADEs to drug company Report ADEs to CVM
Use toll-free number on bottle itself (if you have original packaging)
Report ADEs to CVM
1-888-FDA-VETS

20. What You Need to Know
Good owner-veterinarian communication is KEY to helping prevent or decrease severity of NSAID adverse events

21. Educate Yourself Package Inserts written for veterinarians
but contain important information,
including:
Indications & Usage
Dosage & Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Post Approval Experience (ADEs seen after drug marketed)

22. Educate Yourself Client Information Sheets written for pet owners:
part of labeling for FDA-approved oral NSAIDs
reference information
ask for one--should be sent home with every NSAID prescription (not required by all states)
Communication is Key!

23. Talk with Your Veterinarian
Ask questions about the drug
Ask for a Client Information Sheet
Talk about NSAID benefits and risks
Discuss signs of toxicity
Ask what to do if you see signs:
STOP THE DRUG and
CALL YOUR VETERINARIAN
Communication is Key!

25. Take Home Points Every drug has benefits/risks
Know the signs of NSAID toxicity
Talk with your veterinarian
Ask for a Client Information Sheet with each NSAID prescription
Seeing problems in your dog?
STOP the drug AND
CALL your veterinarian
Report ADEs

26. More Information Center for Veterinary Medicine (CVM) Website:
Veterinary NSAIDs Information:
Free NSAIDs Brochure:
# 503R: Keeping Your Best Friend Active, Safe, and Pain Free
NSAID Labels:

27. Contact CVM Website Address: By Phone: By E-mail:
By Phone:
1-888-INFO FDA By

28. Questions and Answers