An Important Message About DERAMAXX® (deracoxib)
and Recent News Stories
With all of the recent news about Vioxx® (rofecoxib), Celebrex® (celecoxib) and other medications, Novartis Animal Health US, Inc. wants to ensure that you have the most current information about DERAMAXX to discuss with your veterinarian.
Q. Can DERAMAXX cause cardiovascular problems in dogs?
A. The cardiovascular risks suspected to be related to coxib-class NSAIDs in people is extremely unlikely to be an issue in dogs. The risks associated with these drugs in humans involve an increased risk of heart attacks, especially in patients with hypertension (high blood pressure). Heart attacks and hypertension are rarely an issue in healthy dogs. A heart attack occurs when one or more vessels that supply the heart muscle itself with blood become blocked. The blockage is usually caused by cholesterol accumulation along the walls of the blood vessels. This condition is called atherosclerosis, or “hardening of the arteries.” Heart attacks in dogs are rare because dogs are extremely unlikely to get atherosclerosis and dogs have a higher number of vessels which supply blood to the heart. Thus, if one vessel becomes clogged there are additional vessels that supply blood to the heart. High blood pressure is also not a problem in healthy dogs since hypertension in humans is heavily influenced by lifestyle (stress, diet, exercise and smoking).
Q. How do the NSAIDs prescribed for dogs compare?
A. With the widespread news coverage about nonsteroidal anti-inflammatory drugs (NSAIDs), it's easy to assume that these medications are “all the same.” The truth, however, is that all NSAIDs will have a different safety profile depending on the species and the individual. A drug that is safe for humans may not be safe for dogs and vice versa. For example, while ibuprofen is widely used in human patients, it is generally considered toxic for dogs. Also, acetaminophen (Tylenol®) is safe in humans but is considered lethal to cats.
DERAMAXX is proven safe and effective in controlling the pain and inflammation of canine osteoarthritis. In a 2004 survey of pet owners with dogs on DERAMAXX,
- 94% saw a positive improvement in their dog's condition after using DERAMAXX,* and
- 93% were satisfied with the way DERAMAXX relieves their dog's pain*
Q. What can I do to lower the risk of side effects for my dog?
A. It's always important to ask your veterinarian for information about any medication your dog is taking, including DERAMAXX. Because you see your dog every day, you are more likely to detect changes – both good and bad - in your pet's condition.
It's also important for your veterinarian to know all medications your dog may be taking, in order to avoid giving your dog a combination of products that could increase the risk of side effects. Make sure you tell your veterinarian about other medications (supplements, prescription or over-the-counter medications, such as aspirin) your dog may be taking. Make sure you consult with your veterinarian to ensure you understand what side effects to watch for when your dog is on any medication. If your dog experiences any abnormal signs such as vomiting and diarrhea, discontinue the medication and let your veterinarian know immediately. That way it can be determined if other actions are necessary.
Novartis Animal Health US, Inc. provides Client Information Sheets with every DERAMAXX product shipment to help dog owners understand what signs to watch for and report to their veterinarian. To obtain a copy on-line, click
here.
Q. I read in the newspaper that Novartis Animal Health US, Inc. received a letter from FDA about Deramaxx and adverse events. Is this true?
A. Yes, Novartis Animal Health, Inc. did receive a letter from the FDA, however, the letter was not written to address specific safety concerns about Deramaxx or any other Novartis product. Instead, it identified three areas where administrative improvements were needed in order to inform the agency of adverse drug experiences (ADEs) in a timely manner. Novartis has responded to the FDA and is working closely with the agency to resolve issues associated with the processes we use to file ADEs, with a goal of ensuring timely and accurate reporting of ADEs in the future.
Important Safety Information
As with all drugs in this class, side effects involving the digestive system, kidneys or liver may
occur. These are normally mild, but may be serious. Pet owners should discontinue therapy and
contact their veterinarian immediately if side effects occur. Evaluation for pre-existing conditions
and regular monitoring are recommended for pets on any medication, including DERAMAXX.
Use with other NSAIDs or corticosteroids should be avoided or closely monitored.
Click here for full prescribing information.
Vioxx is a registered trademark of Merck & Co., Inc.
Celebrex is a registered trademark of G.D. Searle & Company
Tylenol is a registered trademark of McNeal Consumer & Specialty
* Data on file, Novartis Animal Health US, Inc.