Canine NSAIDs—What Dog Owners Should Know

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 • NOveterinary NSAIDs approved for long-term use in catsin 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 anydrug, including veterinary NSAIDs • CVM promotes safe and effective use of NSAIDs • Package inserts • Client Information Sheets (CISs) • Owners should getCIS 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 • Use toll-free number on bottle itself (if you have original packaging) • Report ADEs to CVM • 1-888-FDA-VETS • http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

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 Insertswritten 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 • Askquestions about the drug • Askfor a Client Information Sheet • TalkaboutNSAID 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? STOPthe drug AND CALLyour veterinarian • Report ADEs

26. More Information • Center for Veterinary Medicine (CVM) Website: http://www.fda.gov/AnimalVeterinary/default.htm • Veterinary NSAIDs Information: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055434.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 • NSAID Labels: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/DrugLabels/ucm050105.htm

27. Contact CVM • Website Address: www.fda.gov/AnimalVeterinary • By Phone: 1-888-INFO FDA • By E-mail: AskCVM@fda.hhs.gov

28. Questions and Answers