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Canine NSAIDs—What Canine NSAIDs—What Dog Owners Should Dog Owners Should KnowKnowAn FDA PerspectiveAn FDA PerspectiveDr. Carmela StamperDr. Carmela Stamper

FDA Center for Veterinary MedicineFDA Center for Veterinary Medicine

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FDA Center for FDA Center for Veterinary MedicineVeterinary Medicine

FDA’s FDA’s Center for Veterinary Center for Veterinary MedicineMedicine (CVM) is a consumer (CVM) is a consumer protection organization. protection organization.

CVM regulates CVM regulates animal drugs (approval and post-animal drugs (approval and post-

approval monitoring)approval monitoring)animal feeds (including pet foods animal feeds (including pet foods

and treats), andand treats), andanimal devices.animal devices.

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How are veterinary How are veterinary drugs approved?drugs approved?

Drug companies conduct the Drug companies conduct the necessary research to support drug necessary research to support drug safety and and effectiveness..

Study data are submitted to CVM for Study data are submitted to CVM for scientific review.scientific review.

CVM determines if data demonstrate CVM determines if data demonstrate the drug is safe and effective when the drug is safe and effective when used as directed on the label. used as directed on the label.

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How are veterinary How are veterinary drugs approved?drugs approved?

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

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How are veterinary How are veterinary drugs approved?drugs approved? For companion animals (like dogs, cats, For companion animals (like dogs, cats,

and horses): and horses):

Pre-approval Pre-approval safety safety studies are almost studies are almost always conducted using young, always conducted using young, healthy animals (generally 32 healthy animals (generally 32 animals).animals).

Pre-approval Pre-approval effectiveness effectiveness studies are studies are generally performed in healthy, client-generally performed in healthy, client-owned animals.owned animals.

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What are “NSAIDs”?What are “NSAIDs”?

Nonsteroidal anti-inflammatory drugs Nonsteroidal anti-inflammatory drugs ((NSAIDsNSAIDs) decrease the prostaglandins ) decrease the prostaglandins in the body by inhibiting the enzyme, in the body by inhibiting the enzyme, cyclooxygenase (COX). cyclooxygenase (COX).

Cyclooxygenase catalyzes the Cyclooxygenase catalyzes the formation of prostaglandins from formation of prostaglandins from arachidonic acid.arachidonic acid.

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How NSAIDs WorkHow NSAIDs Work

Prostaglandins perform severalProstaglandins perform several

important jobs, including:important jobs, including:

promoting inflammation, pain, and promoting inflammation, pain, and feverfever

supporting platelet functionsupporting platelet functionprotecting the stomach lining from protecting the stomach lining from

stomach acid stomach acid maintaining normal kidney functionmaintaining normal kidney function

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What NSAIDs DoWhat NSAIDs Do

NSAIDs help reduce NSAIDs help reduce inflammation, pain, and inflammation, pain, and fever…fever…

BUT…BUT…

they also carry risk of they also carry risk of gastrointestinal gastrointestinal bleeding, ulcers, bleeding, ulcers, perforations, and perforations, and rarely, kidney or liver rarely, kidney or liver damage and death.damage and death.

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Why talk about Why talk about NSAIDs?NSAIDs?

most commonly most commonly prescribed veterinary prescribed veterinary pain relievers, andpain relievers, and

account for the account for the largest largest numbernumber of Adverse of Adverse Drug Events (ADEs) Drug Events (ADEs) reported to CVM.reported to CVM.

Newer “COX-2 selective” NSAIDs Newer “COX-2 selective” NSAIDs shown to be safer on human GI shown to be safer on human GI system but NOT so in veterinary system but NOT so in veterinary medicine*.medicine*.* Based on CVM ADE database.* Based on CVM ADE database.

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Approved NSAIDsApproved NSAIDs

So far, NSAIDs for dogs approved for twoSo far, NSAIDs for dogs approved for two

indications:indications: OsteoarthritisOsteoarthritis Postoperative pain (after Postoperative pain (after

orthopedic and/or soft tissue orthopedic and/or soft tissue surgery)surgery)

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Approved NSAIDsApproved NSAIDs

Risk factors commonly associated with Risk factors commonly associated with thesethese

two groups of patients: two groups of patients:

OsteoarthritisOsteoarthritis→ older dog population → older dog population → can have other diseases at same → can have other diseases at same time (like kidney or liver disease)time (like kidney or liver disease)

Postoperative painPostoperative pain → hydration → hydration status → if dehydrated before, status → if dehydrated before, during, or after surgery, potential during, or after surgery, potential for kidney problemsfor kidney problems

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Approved NSAIDsApproved NSAIDs

Approved VeterinaryApproved Veterinary NSAIDs NSAIDs for for dogsdogs: :

ETOGESIC (etodolac) ETOGESIC (etodolac) RIMADYL (carprofen) RIMADYL (carprofen) METACAM (meloxicam) METACAM (meloxicam) DERAMAXX (deracoxib) DERAMAXX (deracoxib) PREVICOX (firocoxib) PREVICOX (firocoxib) ZUBRIN (tepoxalin) ZUBRIN (tepoxalin) NOVOX (carprofen)NOVOX (carprofen) VETPROFEN (carprofen)VETPROFEN (carprofen)

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Approved Dog NSAIDsApproved Dog NSAIDs

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NSAIDs and CatsNSAIDs and Cats

NONO veterinary veterinary NSAIDs approved NSAIDs approved for for long-term use long-term use in catsin cats in USin US

Cats can’t break Cats can’t break down NSAIDs as down NSAIDs as well as other well as other animalsanimals

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NSAIDs:NSAIDs: BenefitsBenefits

Approved NSAIDsApproved NSAIDs

help our caninehelp our canine

friends byfriends bygiving giving pain reliefpain relief and and

improved quality of improved quality of life to many arthritic life to many arthritic dogs, and dogs, and

helping helping managemanage post- post-surgery pain.surgery pain.

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NSAIDs: RisksNSAIDs: Risks

Risks are associated with use of Risks are associated with use of anyany drug, including veterinary NSAIDs drug, including veterinary NSAIDs

CVM promotes safe and effective use CVM promotes safe and effective use of NSAIDs of NSAIDs Package inserts Package inserts Client Information Sheets (CISs)Client Information Sheets (CISs)

Owners should getOwners should get CISCIS with with everyevery NSAID prescription (but not required in NSAID prescription (but not required in every state)—ask for oneevery state)—ask for one

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NSAIDs: Signs of NSAIDs: Signs of ToxicityToxicity

NSAIDs are associated with NSAIDs are associated with gastrointestinal, kidney, and liver gastrointestinal, kidney, and liver toxicitytoxicity

Most-commonly reported adverse drug Most-commonly reported adverse drug events: events: vomiting, anorexia, vomiting, anorexia, depression, and diarrheadepression, and diarrhea

Other adverse drug events: stomach Other adverse drug events: stomach ulcers, intestinal ulcers/perforation, ulcers, intestinal ulcers/perforation, kidney and liver failure, and death. kidney and liver failure, and death.

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Adverse Drug Events Adverse Drug Events (ADEs)(ADEs)

Voluntarily-reported by veterinarians, Voluntarily-reported by veterinarians, pet owners, and others to drug pet owners, and others to drug company and/or CVM company and/or CVM

Companies required to report all ADEs Companies required to report all ADEs to CVM to CVM

CVM stores ADE reports in database CVM stores ADE reports in database CVM veterinarians analyze all ADE CVM veterinarians analyze all ADE

reports reports

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Report ADEsReport ADEs

Report ADEs Report ADEs to drug companyto drug company– Use toll-free number on bottle itself (if you Use toll-free number on bottle itself (if you

have original packaging)have original packaging)

Report ADEs Report ADEs to CVMto CVM– 1-888-FDA-VETS1-888-FDA-VETS– http://www.fda.gov/AnimalVeterinary/http://www.fda.gov/AnimalVeterinary/

SafetyHealth/ReportaProblem/SafetyHealth/ReportaProblem/ucm055305.htmucm055305.htm

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What You Need to What You Need to KnowKnow

Good owner-veterinarian Good owner-veterinarian communication is communication is KEYKEY to to

helping prevent or decrease helping prevent or decrease severity of NSAID adverse severity of NSAID adverse

eventsevents

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Educate YourselfEducate Yourself

Package InsertsPackage Inserts written for veterinarianswritten for veterinarians

but contain important information,but contain important information,

including:including:

– Indications & UsageIndications & Usage– Dosage & AdministrationDosage & Administration– Contraindications Contraindications – WarningsWarnings– PrecautionsPrecautions– Adverse ReactionsAdverse Reactions– Post Approval Experience (ADEs seen after drug marketed)Post Approval Experience (ADEs seen after drug marketed)

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Educate YourselfEducate Yourself

Client Information Sheets Client Information Sheets written forwritten for

pet ownerspet owners:: part of labeling for FDA-approved part of labeling for FDA-approved

oral NSAIDsoral NSAIDs reference information reference information ask for one--should be sent home ask for one--should be sent home

with with everyevery NSAID prescription (not NSAID prescription (not required by all states)required by all states)

Communication is Key!Communication is Key!

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Talk with Your Talk with Your VeterinarianVeterinarian

AskAsk questionsquestions about the drug about the drug AskAsk for a Client Information Sheet for a Client Information Sheet TalkTalk aboutabout NSAID benefits and risksNSAID benefits and risksDiscussDiscuss signs of toxicity signs of toxicityAsk what to doAsk what to do if you see signs: if you see signs:

STOP THE DRUGSTOP THE DRUG and and CALL YOUR VETERINARIANCALL YOUR VETERINARIAN

Communication is Key!Communication is Key!

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Take Home PointsTake Home Points

Every drug has benefits/risksEvery drug has benefits/risks Know the signs of NSAID toxicity Know the signs of NSAID toxicity Talk with your veterinarianTalk with your veterinarian Ask for a Ask for a Client Information SheetClient Information Sheet

with each NSAID prescriptionwith each NSAID prescription Seeing problems in your dog? Seeing problems in your dog?

STOPSTOP the drug ANDthe drug ANDCALLCALL your veterinarianyour veterinarian

Report ADEsReport ADEs

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More InformationMore Information

Center for Veterinary Medicine (CVM) Center for Veterinary Medicine (CVM) Website: Website: http://www.fda.gov/AnimalVeterinary/default.htmhttp://www.fda.gov/AnimalVeterinary/default.htm

Veterinary NSAIDs Information:Veterinary NSAIDs Information:http://www.fda.gov/AnimalVeterinary/SafetyHealth/http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055434.htmProductSafetyInformation/ucm055434.htm

Free NSAIDs Brochure:Free NSAIDs Brochure: www.pueblo.gsa.govwww.pueblo.gsa.gov

# 503R: Keeping Your Best Friend Active, Safe, and Pain Freehttp://www.pueblo.gsa.gov/cic_text/misc/dog/treatdog.htm

NSAID Labels:NSAID Labels:http://www.fda.gov/AnimalVeterinary/Products/http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/DrugLabels/ucm050105.htmApprovedAnimalDrugProducts/DrugLabels/ucm050105.htm

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Contact CVMContact CVM

Website Address:Website Address:www.fda.gov/www.fda.gov/

AnimalVeterinaryAnimalVeterinary

By Phone:By Phone:1-888-INFO FDA1-888-INFO FDA

By E-mail:By E-mail:AskCVM@fda.hhs.govAskCVM@fda.hhs.gov

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Questions and Questions and AnswersAnswers