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

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.

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.

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

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.

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.

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

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.

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.

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

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

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

Approved Dog NSAIDs

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

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.

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

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.

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

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 http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

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

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)

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!

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!

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

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

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

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