Your 8-year-old yellow Lab Tinker Bell just came in from the backyard and you notice she’s limping on one of her back legs. You check the medicine cabinet in your bathroom to see what medications you have that may help her feel better. You see bottles of aspirin, ibuprofen, naproxen, and acetaminophen—all pain relievers for people. You also have a few tablets of RIMADYL left over from when your other dog had knee surgery. Before reaching for any of the bottles, STOP and call your veterinarian. A pain reliever meant for you or even for your other dog may not be right for Tinker Bell and may even hurt her.

What should you do?

• Before giving any NSAID to your dog or cat, talk with your veterinarian. Tell him or her if your pet:
  • Has a history of digestive problems, such as stomach or intestinal ulcers, or has had surgery on the stomach or intestines. Even if your pet hasn’t had any digestive problems in the past, that doesn’t mean he or she has a healthy digestive tract. Dogs and cats can have stomach and intestinal ulcers without showing signs.
  • Is on any other medication. It’s not recommended to give two different NSAIDs, or an NSAID and a steroid, at the same time.
• During and after NSAID therapy, monitor your pet for side effects, such as vomiting, diarrhea, bloody or tar-colored stool, decreased appetite, decreased activity level, yellowing of the whites of the eyes, and yellowing of the gums. These signs can occur even in a previously healthy pet. If you notice any side effects, stop giving the drug and call your veterinarian.
• If your pet experiences side effects from an NSAID, FDA’s Center for Veterinary Medicine encourages you to work with your veterinarian to report the problem.
• Before starting your dog on an NSAID for long-term use for osteoarthritis, ask your veterinarian about performing baseline bloodwork. Talk to your veterinarian about how often to recheck your dog’s bloodwork. No NSAID is currently FDA-approved for long-term use in cats.
• Going back to Tinker Bell, you shouldn’t give her anything in your medicine cabinet until you talk to your veterinarian.

With the notable exception of acetaminophen, all the medications listed in the introduction are nonsteroidal anti-inflammatory drugs, commonly called NSAIDs. These drugs are widely used in both people and animals for their pain relieving, anti-inflammatory, and anti-fever properties. Veterinarians often prescribe NSAIDS for dogs with osteoarthritis, a condition where cartilage - the protective material that cushions a joint - breaks down over time, causing the bones to rub against each other. This rubbing can permanently damage the joint and cause pain, inflammation, and lameness. Veterinarians also often use NSAIDs to manage pain after surgery in both dogs and cats.

The Science—How NSAIDs Work

Nonsteroidal anti-inflammatory drugs affect substances called prostaglandins that the body releases in response to irritation or injury. When a cell is damaged, an enzyme called cyclooxygenase (COX) is activated. An enzyme is a protein made by the body that speeds up a chemical reaction. The enzyme itself remains unchanged during the reaction. Essential to all body functions, enzymes are very specific—each enzyme stimulates a specific reaction that causes a specific result.

In the case of the enzyme COX, it stimulates cells to produce several substances, including prostaglandins, after the cells are damaged. COX is present in most body tissues, including the digestive tract (stomach and intestines) and kidneys.

Prostaglandins are present throughout the body and have several important functions. These substances:

• Contribute to pain, inflammation, and fever;
• Protect the lining of the stomach and intestines;
• Help maintain blood flow to the kidneys; and
• Support platelet function (platelets are found in the blood of all mammals and help with blood clotting).

Many NSAIDs work by blocking COX, so fewer prostaglandins are produced:

Other NSAIDs work by blocking some activity of certain prostaglandins:

By either blocking COX or blocking some activity of certain prostaglandins, NSAIDs reduce ongoing pain and inflammation in animals. But because these drugs also interfere with the other positive functions of prostaglandins, they can cause side effects, some of which are serious.

Side Effects

Some of the most common side effects of NSAIDs in animals reported to FDA’s Center for Veterinary Medicine are:

• Vomiting;
• Decreased to no appetite;
• Decreased activity level; and
• Diarrhea.

Other reported side effects in animals include stomach and intestinal ulcers, stomach and intestinal perforations (holes in the wall of the stomach or intestines), kidney failure, liver failure, and death.

The side effects of NSAIDs are mainly seen in the digestive tract, kidneys, and liver.

The Digestive Tract (Stomach and Intestines)

Nonsteroidal anti-inflammatory drugs can cause side effects in the digestive tract both directly and indirectly. The direct effects are related to the drugs’ physical properties. Many NSAIDs become trapped in the stomach and are also slightly acidic, so they directly irritate the stomach lining.

The indirect effects are due to NSAIDs either preventing the body from making prostaglandins or blocking the protective activity of these substances. Remember, besides decreasing pain, inflammation, and fever, prostaglandins also protect the lining of the stomach and intestines. When fewer prostaglandins are produced or some of their activity is blocked, the entire digestive tract may be more prone to damage. This can lead to ulcers and perforations in the stomach and intestines.

Giving an animal two NSAIDs at the same time, or an NSAID with a steroid such as prednisone, increases the risk of side effects in the digestive tract and should be avoided.

Kidneys

During periods of decreased blood flow to the kidneys—such as when an animal is dehydrated, under anesthesia, or has kidney disease—prostaglandins cause the arteries going to the kidneys to open. This helps keep blood flowing to these vital organs.

Because NSAIDS prevent the production of prostaglandins or block some prostaglandin activity, these drugs can reduce blood flow to the kidneys, possibly causing kidney damage and leading to sudden-onset kidney failure.

NSAIDs should be used cautiously in animals that may already have kidney disease or other conditions that cause reduced blood flow to the kidneys, like dehydration and shock. If an NSAID is used around the time of surgery, intravenous (IV) fluids are generally recommended before, during, and after anesthesia to maintain blood flow to the kidneys, hopefully reducing potential kidney complications.

Liver

The side effects of NSAIDs on the liver can be divided into two categories: (1) dose-dependent toxicity; and (2) dose-independent toxicity.

As the name implies, dose-dependent liver toxicity is related to the dose—the higher the dose of the NSAID, the worse the liver damage. Dose-dependent liver toxicity is typically caused by a massive NSAID overdose, such as a dog eating an entire bottle of his owner’s ibuprofen. (The ASPCA Animal Poison Control Center receives hundreds of calls each year involving dogs and cats that accidentally eat nonsteroidal anti-inflammatory drugs.)

Dose-independent liver toxicity can occur at any dose, even the correct one, and is an unpredictable and rare reaction where the patient’s liver has an abnormal sensitivity to the NSAID.

NSAIDs should be used cautiously in animals that may already have liver disease. For a dog starting on an NSAID for long-term use for osteoarthritis, it’s good to closely monitor his or her liver function by checking bloodwork during the early stages because most NSAID-associated liver damage occurs within the first three weeks.

Keeping Your Best Friend Active, Safe, And Pain Free

Controlling your dog’s pain is essential to his overall well-being. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are a class of drugs commonly used to control pain and inflammation in dogs. NSAIDs help many dogs lead more comfortable lives.

What are NSAIDs?

NSAIDs help to control signs of arthritis, including inflammation, swelling, stiffness, and joint pain. Inflammation—the body’s response to irritation or injury—is characterized by redness, warmth, swelling, and pain. NSAIDs mediate the production or function of prostaglandins (enzymes) involved in inflammation. Some NSAIDs may also be used to control the pain and inflammation following surgery.

Your veterinarian may prescribe an NSAID to treat the pain of osteoarthritis in your dog or to control pain following a surgical procedure.

All NSAIDs approved for oral use in dogs and cats come with a Client Information Sheet (also known as the Information for Dog Owner Sheet) that describes the drug’s side effects. Dog and cat owners should ask veterinarians for the Client Information Sheet when an NSAID is prescribed. These Client Information Sheets provide the pet owner with important information in a user-friendly manner regarding what can be expected from use of the drug, potential side effects, and the need to seek veterinary attention if problems occur. By accompanying each NSAID prescription with the Information for Dog Owner Sheet, a handy reference of valuable safety information and drug company contact information is readily available to the owner.

Veterinary NSAIDs approved for use in dogs:

• ETOGESIC (etodolac) - not currently marketed
• RIMADYL (carprofen)
• METACAM (meloxicam)
• DERAMAXX (deracoxib)
• PREVICOX (firocoxib)
• ZUBRIN (tepoxalin) - not currently marketed
• NOVOCOX (carprofen)
• VETPROFEN (carprofen)
• CARPRIEVE (carprofen)
• QUELLIN (carprofen)
• OROCAM (meloxicam)
• LOXICOM (meloxicam)
• MELOXIDYL (meloxicam)
• ONSIOR (robenacoxib) for a maximum of 3 day use
• GALLIPRANT (grapiprant)
  

In the United States, there is one NSAID approved for up to 3 days use in cats to control pain associated with surgery: ONSIOR (robenacoxib) tablets or ONSIOR (robenacoxib) injection. Meloxicam injection is approved for a single injection to control pain associated with surgery in cats.

What should you discuss with your veterinarian?

NSAIDs offer pain relief and improved quality of life to many dogs. However, before giving an NSAID, or any drug, you should first talk to your veterinarian.

You should discuss:

• what the NSAID is being prescribed for
• how much to give
• how long to give it
• possible side effects
• what to avoid while your dog is taking an NSAID
• what tests are needed before giving an NSAID to your dog
• how often should your dog be re-examined
• your dog’s previous medical history and any previous drug reactions
• all medications and products your dog currently receives

What should you know before giving your dog an NSAID?

• Never give aspirin or corticosteroids along with an NSAID to your dog.
• NSAIDs should be approached cautiously in dogs with kidney, liver, heart and intestinal problems.
• Never give your dog an NSAID unless directed by your veterinarian.
• Don’t assume an NSAID for one dog is safe to give to another dog. Always consult your veterinarian before using any medication in your pet.
• Only give the NSAID as prescribed by your veterinarian. Do not increase the dose, the frequency, or the length of time you use the drug unless first discussing this with your veterinarian.

What side effects should you watch for?

Most NSAID-side effects are mild, but some can be serious, including death in rare situations. Common side effects seen with the use of NSAIDs in dogs may affect the kidneys, liver, and gastrointestinal tract and may include:

• Not eating or eating less
• Lethargy, depression, changes in behavior
• Vomiting
• Diarrhea, black tarry-colored stool
• Yellowing of gums, skin, or the whites of the eyes
• Change in drinking
• Changes in skin (scabs, redness, or scratching)

What to do?

If you suspect a possible side effect to an NSAID, STOP giving the drug to your dog and call your veterinarian immediately!

When Giving Your Best Friend an NSAID, Remember these Signs:

• Behavior Changes
• Eating Less
• Skin Redness, Scabs
• Tarry Stool/Diarrhea/Vomiting
• FRIEND

STOP the Drug & Call Your Veterinarian!

When your veterinarian prescribes medication for your pet, it’s sometimes hard to remember all the information discussed during the visit. Fortunately, you can receive a Client Information Sheet from your veterinarian to answer questions and explain the medication.

What is a Client Information Sheet?

A Client Information Sheet (CIS) is written specifically for pet owners, in a user-friendly, question-and-answer format. The handout gives you detailed information about your pet’s medication and the side effects it can cause, helping you use the medication as safely and effectively as possible for your pet. A Client Information Sheet tells you:

• what the drug’s name is and what type of drug it is,
• what you can expect the drug to do for your pet,
• what the drug’s potential side effects are, and
• what you should do if you see side effects in your pet.

A Client Information Sheet is different from the medication’s package insert. Although the package insert also explains how the drug works and what the potential side effects are, it’s written for a veterinarian.

Where can I get a Client Information Sheet?

You can get a Client Information Sheet from your veterinarian. Not all veterinary medications, however, have Client Information Sheets available. Generally, they’re written for medications where owner involvement is important for safe and effective use. Some FDA-approved veterinary medications that have Client Information Sheets include:

• Non-steroidal anti-inflammatory drugs (NSAIDs) for companion animals
• Vetoryl (trilostane)
• Felimazole (methimazole)
• Palladia (toceranib phosphate)
• Comfortis (spinosad)
• Trifexis (spinosad and milbemycin)
• ProZinc (protamine zinc human recombinant insulin)
• Recuvyra (fentanyl)

You should receive a Client Information Sheet every time you receive a prescription for any of the medications listed above; whether it’s the first time your pet is receiving it or the 15th refill. In fact, the package inserts for these medications inform the veterinarian to “Always provide a client information sheet with prescription.”

Why is a Client Information Sheet important?

A Client Information Sheet is an important, helpful reminder about your pet’s medication. If you think your pet is having a problem with the medication, you can refer to the Client Information Sheet for advice. By helping you recognize possible side effects, the handout can increase your pet’s chance for a good recovery.

What should I do if I think my pet is having side effects from a medication?

The most important thing you should do if you think your pet is having side effects from a medication is call your veterinarian immediately! Your veterinarian can determine whether your pet should be seen and whether you should stop giving your pet its medication.

My pet had a side effect from a medication. Where can I report it?

If your pet had a side effect from a medication, report the incident! Side effects, also called adverse drug experiences, should first be reported to the drug company by calling the phone number on the Client Information Sheet or on the medication’s label. Drug companies are required by law to send all reports of side effects they receive to the FDA Center for Veterinary Medicine (CVM) within certain time frames. If you tell the drug company about your pet’s side effect, the report will reach FDA.

What does CVM do with reports of side effects?

When CVM receives reports of side effects from drug companies, veterinarians, or pet owners, the center’s scientists enter the information into an online database of adverse drug experiences. CVM scientists use the ADE database to make decisions about product safety which may include changes to the label or other regulatory actions. Updated labels help veterinarians use medications more safely and effectively in their patients.

Veterinarians and pet owners aren’t required to report side effects to the drug company or CVM. However, the more complete the database, the better informed our scientists are when making product safety decisions. So please report medication side effects in your pet!

Communication is Key

All medications have risks and benefits. While your veterinarian is the most qualified source of information about your pet’s medications and care, Client Information Sheets put helpful information right in your hand. When your veterinarian prescribes medication for your pet, ask if a Client Information Sheet is available.

Remember: Being an informed owner is your pet’s best defense against serious side effects from any medication!

FDA has approved several nonsteroidal anti-inflammatory drugs for dogs to control pain and inflammation associated with osteoarthritis; and to control pain and inflammation after soft tissue and orthopedic surgery. [Orthopedic pertains to bones and muscles; soft tissue is everything else. Repairing a dog’s torn ACL (anterior cruciate ligament) in her knee is an orthopedic surgery; removing a ball from a dog’s stomach is a soft tissue surgery.]

Table 1: Some FDA-Approved Nonsteroidal Anti-Inflammatory Drugs for Dogs

*Indicates an FDA-approved generic copy.

All NSAIDs for dogs are given either by mouth (oral) or by injection.

Unlike the other NSAIDs listed in the above table, ONSIOR (robenacoxib) is not approved for long-term use in dogs with osteoarthritis. It should only be used for a maximum of 3 days to control pain and inflammation after soft tissue surgery.

Only two NSAIDs are FDA-approved for cats: meloxicam (sold under the brand names METACAM, MELOXICAM,* and LOXICOM*) and robenacoxib (sold under the brand name ONSIOR).

Meloxicam is approved for cats as a one-time-only injection to control pain and inflammation after spaying, neutering, and orthopedic surgery; the injection is given under the cat’s skin before surgery.

Robenacoxib is also approved for cats to control pain and inflammation after spaying, neutering, and orthopedic surgery. The drug should be used once daily for no more than three days, and is available as either a tablet given by mouth or an injection given under the cat’s skin.

Currently, no NSAIDs are approved for long-term use in cats. More than one dose of meloxicam in cats can cause kidney failure or death, and the effects of long-term use of other NSAIDs in cats are unknown. Cats are more sensitive than dogs to the side effects of NSAIDs because they aren’t able to break down the drugs as well.

All FDA-approved NSAIDs for dogs and cats are by a veterinarian's prescription only.

Benefits

A main benefit of an FDA-approved nonsteroidal anti-inflammatory drug for dogs or cats is that it has been shown to be safe and effective in that species when used according to the label. Pain relievers for people don’t have the same assurances of safety and effectiveness in pets.

A second main benefit is that the label for an FDA-approved NSAID for dogs or cats is written specifically for that species. The label includes all the information veterinarians need to use the drug safely and effectively in that species.

A Balancing Act—Benefits versus Risks

FDA-approved nonsteroidal anti-inflammatory drugs offer pain relief for many dogs with osteoarthritis. These drugs also help veterinarians effectively manage pain after surgery in both dogs and cats. Yet, there are risks.

NSAIDs account for a large number of adverse drug events reported to FDA’s Center for Veterinary Medicine. Adverse drug events are undesired side effects associated with a drug.

If you consider the two most common populations of pets that receive NSAIDs, you can see why there are so many reported side effects:

• Dogs with osteoarthritis. These dogs are usually older and often have another disease in addition to osteoarthritis, such as kidney or liver disease.
• Surgery patients. These dogs and cats were recently under anesthesia which reduces blood flow to the kidneys.

Risk Reduction

All drugs can cause side effects. FDA’s Center for Veterinary Medicine tries to reduce the risks of side effects associated with NSAIDs by working with drug companies to write clear, thorough drug labels for veterinarians and Client Information Sheets for owners.

Every oral NSAID approved for dogs and cats has an accompanying Client Information Sheet for veterinarians to give owners the first time the prescription is filled and each time it's refilled. This sheet summarizes important safety information about the drug and serves as an easy reference for you at home.

The label of every approved injectable NSAID for pets has a section called “Information for Dog Owners” or “Information for Cat Owners.” Before using the drug in your pet, your veterinarian should discuss the information in this section with you.

Dogs are Not Small People.

Tinker Bell’s owner isn’t alone. When owners see their dog or cat limping or showing other signs of pain, they often think about giving their pet an over-the-counter pain reliever for people. But even if data show an NSAID is safe and effective in people, the drug may not be safe and effective in dogs because the drug may:

• Last longer;
• Have a higher absorption rate in the stomach and intestines; and
• Reach higher blood levels.

Cats are Not Small People or Small Dogs.

You have to be even more careful with cats. Compared to other species, cats have a reduced ability to break down NSAIDs.

These differences may lead to toxic effects in pets, such as ulcers and perforations in the digestive tract as well as liver and kidney damage.

Table 2: Common Over-the-Counter Pain Relievers for People

Acetaminophen is not a nonsteroidal anti-inflammatory drug and doesn’t have much anti-inflammatory activity. Scientists don’t fully understand how acetaminophen works. The drug seems to have more than one mode of action to reduce fever and relieve pain.

Acetaminophen has two main forms of toxicity:

• Dose-dependent liver toxicity—meaning the higher the dose, the worse the liver damage—that may lead to liver failure; and
• Red blood cell damage that causes these cells to lose their ability to carry oxygen.

Dogs and cats can develop both forms of acetaminophen toxicity, but cats are more prone to red blood cell damage while dogs are more likely to get liver damage.

Acetaminophen is fatal to cats. Cats should never be given acetaminophen because they lack certain enzymes that the liver needs to safely break down the drug.

Your 9-year-old German Shepherd is limping, and you think that arthritis may be setting in. A trip to the veterinarian proves that you’re right—it’s osteoarthritis, a degeneration of the cartilage and bone that affects joints. The veterinarian prescribes a non-steroidal anti-inflammatory drug (NSAID).

NSAIDs are a class of drugs extensively used in both human and veterinary medicine for their anti-fever, anti-inflammatory and pain-relieving properties, and they are the most commonly prescribed pain relievers for animals. Inflammation—the body’s response to irritation or injury—is characterized by redness, warmth, swelling, and pain. NSAIDs work by blocking the production of chemicals produced by the body that play a role in inflammation.

“Scientists consider NSAIDs the cornerstone of osteoarthritis therapy in dogs,” says Melanie McLean, D.V.M., a veterinarian at the Food and Drug Administration (FDA). Some NSAIDS are also used to manage pain after surgery in both dogs and cats. No NSAID has been approved for long-term use in cats.

NSAIDs carry risks as well as benefits, however, and all dogs and cats should undergo a thorough physical examination by a veterinarian—including a discussion of the pet’s medical history— before beginning NSAID therapy. McLean notes that it’s also important that you talk to your veterinarian about possible side effects, including those that could signal danger.

Risks and Side Effects

NSAIDS are associated with gastrointestinal ulcers/perforations, kidney, and liver toxicity (damage done by exposure to medications or chemicals) and must be used cautiously in animals with pre-existing kidney or liver problems.

Because most liver-associated toxicities occur during the first three weeks, it’s especially important to closely monitor the results of blood tests during the early stages of long-term NSAID treatment in dogs. Also, before starting long-term treatment with NSAIDs in dogs, blood tests should be conducted to establish baseline data and then repeated on a regular basis. McLean recommends that you talk with your veterinarian about how often this blood work should be done.

Some of the most common side effects of NSAIDS in animals reported to FDA are:

• vomiting
• decreased to no appetite
• decreased activity level
• diarrhea

While your animal is taking NSAIDs, continuously monitor the pet for these side effects as well as looking for blood in the feces, tar-like stools, yellowing of the whites of the eyes, or yellowing of the gums. If you see these, call your veterinarian immediately, McLean says. Other reported side effects include stomach and intestinal ulcers, intestinal perforation (a hole in the wall of the intestine), kidney failure, liver failure and death.

Giving two NSAIDs at the same time, or giving an NSAID with a steroid, such as prednisone, can significantly increase the risk and severity of side effects, especially gastrointestinal toxicity.

Risks associated with NSAIDs are detailed on the package inserts and the client information sheets that accompany all FDA-approved veterinary oral NSAIDs.

Are OTC Meds for People Safe for Pets?

McLean says that it’s not unusual for pet owners to want to give their animals NSAIDs or acetaminophen (Tylenol and other brands, which are not NSAIDs) straight from their own medicine cabinets. “Many people don’t realize that a medicine that’s safe for people may not be safe for dogs or cats, or that a dose that is safe for people may not be safe for their pets,” she notes.

In fact, some over-the-counter (OTC) human pain relievers can be toxic, or even deadly, in pets. McLean suggests that you check with your veterinarian first if you want to give your animal OTC human drugs.

“You should always check with your veterinarian first before giving your animal any kind of medication, prescription or over-the-counter,” she notes. Similarly, pet owners should not assume that a medicine that is safe for one animal is necessarily safe for another.

Communication with your veterinarian is essential. Before giving your animal an NSAID:

• Make sure you know what the medication is being prescribed for, how much to give and how long to give it.
• Discuss possible side effects and symptoms, especially those that require an immediate call to the vet.
• Tell your veterinarian if the pet has a history of gastrointestinal problems, such as stomach ulcers, or surgery on the stomach or intestines.
• Tell your veterinarian if your pet is on any other medications or supplements.

Non-steroidal anti-inflammatory drugs (NSAID) have provided pain control for many dogs and offer significant benefits. But it is important that you are aware of potential side effects when administering drugs to your dog. All NSAIDs should be used with caution, because they all have the potential for serious side effects, especially gastrointestinal bleeding, ulcers, and perforations, and in rare cases, kidney damage and liver problems.

The best way to avoid the possibility of your dog suffering serious side effects from NSAIDs is for you to be fully informed about the drug and its potential side effects.

NSAIDs approved for use in dogs often contain the following information on their labels:

• All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish baseline blood values prior to, and periodically during, the use of any NSAID are strongly recommended.
• Always provide “Information for Dog Owners” (Client Information) Sheet with prescription.

As an owner, you should receive a Client Information Sheet with every NSAID prescription. You should ask your veterinarian for this sheet if you do not receive one. One way to be better informed is to read this information carefully before administering the medication to your dog, so that you understand the side effects that your dog may experience.

When administering an NSAID, you should watch for these side effects:

• Decrease or increase in appetite
• Vomiting
• Change in bowel movements (such as diarrhea, or black, tarry, or bloody stools)
• Change in behavior (such as decreased or increased activity level, incoordination, seizure or aggression)
• Yellowing of gums, skin, or whites of the eyes (jaundice)
• Change in drinking habits (frequency, amount consumed)
• Change in urination habits (frequency, color, or smell)
• Change in skin (redness, scabs, or scratching)

If you notice any of these possible side effects, stop the medication and contact your veterinarian.

The side effects listed on the label are the most common. All possible side effects are not included. Always contact your veterinarian if you have questions about your dog’s medication.

What starts out as a minor problem can readily progress to an emergency. If you feel that your concerns are not taken seriously, you should get another opinion. You may even call the drug manufacturer (a toll free number appears on each Client Information Sheet). Pharmaceutical companies offer customer service and technical support for product information and quality control. When possible problems are experienced with a product, the manufacturer may have specific recommendations for your veterinarian regarding tests and treatments.

Reporting adverse drug experiences

If you or your veterinarian suspect a potential reaction associated with the use of an NSAID (or any drug), report it to the pharmaceutical company. All NSAIDs approved for use in dogs have a toll free number on their labels to which a suspected reaction can be reported. If unable to report problems directly to the pharmaceutical company, veterinarians and dog owners are encouraged to report veterinary Adverse Drug Experiences (ADE) and suspected product failures to the government agency that regulates the product in question. In the case of NSAIDs, the adverse experiences are to be reported to the Center for Veterinary Medicine.

Osteoarthritis (OA) is a condition where cartilage - the protective material that cushions a joint - breaks down over time, causing the bones to rub against each other. This rubbing can permanently damage the joint and cause pain, inflammation, and lameness. Older and overweight dogs are at higher risk of developing OA.

Available since March 2016, Galliprant (grapiprant tablets) is the most recently approved treatment option for dogs with OA. The drug helps control the pain and inflammation caused by the condition. Galliprant is part of a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Several other NSAIDs are approved to control pain and inflammation in dogs with OA (see Table 1), but Galliprant works at a slightly different point on the inflammatory pathway.

Table 1: FDA-Approved Oral Nonsteroidal Anti-Inflammatory Drugs for Dogs with Osteoarthritis

*Indicates an FDA-approved generic copy.

Inflammatory Pathway

Inflammation is the body’s response to irritation or injury. After a cell is damaged, an enzyme called cyclooxygenase (COX) is activated. (An enzyme is a protein made by the body that speeds up a chemical reaction.) COX then stimulates the cell to produce substances called prostaglandins, which contribute to signs of inflammation such as pain, redness, warmth, swelling, and fever.

The inflammatory pathway works like this:

Prostaglandins are present throughout the body and have several important functions besides contributing to the inflammatory pathway. Prostaglandins also protect the lining of the stomach and intestines; help maintain blood flow to the kidneys; and support platelet function (platelets are found in the blood of all mammals and help with blood clotting).

Galliprant Blocks Activity of a Specific Prostaglandin

All NSAIDs affect prostaglandins, either by blocking COX so fewer prostaglandins are produced or by blocking some activity of certain prostaglandins. The result is less pain and inflammation.

Most NSAIDs listed in Table 1 work by blocking COX:

Galliprant is an NSAID that does not block COX. It works lower down the inflammatory pathway by blocking some activity of a specific prostaglandin:

Side Effects and Client Information Sheet

Because all NSAIDs interfere with the other positive functions of prostaglandins, they can cause side effects, some of which are serious. Galliprant is no exception. The most common side effects seen in dogs receiving Galliprant are:

• Vomiting;
• Diarrhea;
• Decreased appetite;
• Soft stool with mucus; and
• Watery or bloody stool.

Giving Galliprant and another NSAID for dogs (for example, carprofen or meloxicam) at the same time or giving Galliprant with a steroid such as prednisone increases the risk of side effects and should be avoided. Giving Galliprant and an NSAID for people (for example, aspirin or ibuprofen) at the same time also increases the risk of side effects and should be avoided. NSAIDs for people are not approved for animals and have not been shown to be safe and effective in dogs.

Owners should contact their veterinarian if their dog experiences side effects from Galliprant. FDA’s Center for Veterinary Medicine also encourages owners to work with their veterinarian to report the problem.

Every oral NSAID approved for dogs, including Galliprant, has an accompanying Client Information Sheet for veterinarians to give owners the first time the prescription is filled and each time it's refilled. The Client Information Sheet for Galliprant is written specifically for dog owners and serves as an easy at-home reference. The sheet summarizes important information about the drug in a user-friendly format.

Long-Term Use

Because OA is a long-term (chronic) condition that doesn’t go away, a dog may be on Galliprant for an extended period of time. The lowest dose that provides adequate pain control should be used. Owners should always consult with their veterinarian before adjusting the dose, especially before increasing it.

Owners should ask their veterinarian about performing baseline bloodwork to check kidney and liver function before starting their dog on Galliprant for long-term use for OA. Owners should also periodically discuss their dog’s response to Galliprant with their veterinarian, including what type of monitoring should be done (such as rechecking bloodwork) and how often.