Novartis Animal Health US, Inc.
3200 Northline Avenue
Greensboro, NC 27408
P.O. Box 26402
Greensboro, NC 17404-6402
December 22, 2003
At Novartis Animal Health, we are committed to providing
you with the knowledge you need to prescribe our products
with confidence. We are sending this letter with confidence.
We are sending this letter to share new information about
Deramaxx® (deracoxib), our coxib-class nonsteroid anti-inflammatory
Since its introduction in August 2002, Deramaxx has been
used safely and effectively in hundreds of thousands of dogs
and more than 15 million tablets have been dispensed. (1).
As is often the case when a drug begins to be used widely
in a clinical setting, new information and insights about
Deramaxx have come to light. With guidance from the Food and
Drug Administration, Center for Veterinary Medicine (FDA/CVM),
we have updated the package insert to include a section reporting
post-approval adverse events. In addition, this letter includes
important guidelines that may help minimize future adverse
As a matter of policy, Novartis Animal Health submits all
adverse event reports from practicing veterinarians and consumers
to the Food and Drug Administration, Center for Veterinary
Medicine (FDA/CVM), including observations which are later
determined to be unrelated to administration of our products.
In addition, FDA/CVM receives reports directly from veterinarians
and consumers. Based on the findings, a new label statement
has been approved for Deramaxx incorporating post-approval
experiences with the medication. The updated section of the
Deramaxx label reads:
The following adverse reactions are based on voluntary
post-approval reporting. The categories are listed in decreasing
order of frequency by body system.
· Gastrointestinal: vomiting, anorexia,
diarrhea, melena, hematemesis, hematochezia, weight loss,
nausea, gastrointestinal ulceration, gastrointestinal perforation,
· Hematological: anemia, thrombocytopenia.
· Hepatic: hepatic enzyme elevations,
decreased or increased total protein and globulin, decreased
albumin, decreased BUN, icterus, ascites, pancreatitis.
· Neurological/Behavioral/Special Sense:
lethargy, weakness, seizure, ataxia, aggression, tremor,
glazed eyes, uveitis, mydriasis, nystagmus.
· Urinary: azotemia, polydipsia,
polyuria, urinary tract infection, hematuria, urinary incontinence,
· Cardiovascular/Respiratory: tachypnea,
fever, facial/muzzle edema, pruritis, urticaria, moist dermatitis.
In rare situations, death has been reported as an outcome
of the adverse reactions listed above.
The following information has also been moved from the Precautions
section to the Warnings section of the veterinary label to
highlight the importance of careful patient selection:
Sensitivity to drug-associated adverse events varies with
the individual patient. As a class, cyclooxygenase inhibitor
NSAIDs maybe associated with gastrointestinal and renal toxicity.
Patients at greatest risk for NSAID toxity are those that
are dehydrated, on concomitant diuretic therapy, or those
with existing renal, cardiovascular and/or hepatic dysfunction.
Since may NSAIDs possess the potential to produce gastrointestinal
ulceration, concomitant us of DERAMAXX tablets with other
anti-inflammatory drugs, such as NSAIDs or corticosteroids,
should be avoided or closely monitored.
It should be noted that many of the side effects associated
with Deramaxx administration occurred in cases in which dogs
were also receiving corticosteroids or other NSAIDs. As stated
on our original label—and that of all veterinary-approved
NSAIDS—concomitant use of multiple anti-inflammatory
drugs, such as NSAIDS or corticosteroids, should be avoided
or closely monitored. It is important to thoroughly review
a patient’s medical and therapeutic history when starting
therapy with any NSAID, including Deramaxx.
Dosage and Administration
In addition, it is important to note that a significant number
of the adverse reactions reported with Deramaxx were associated
with inappropriate dosing of the medication. The approved
dose for controlling pain and inflammation associated with
orthopedic surgery is 3-4 mg/kg/day as a single daily dose,
as needed, not to exceed 7 days. For control of pain and inflammation
associat4ed with osteoarthritis, the approved dose is 1-2
mg/kg/day as a single daily dose as needed.
Recommended Guidelines for Deramaxx Use
In summary, the safe and effective use of our products
is a primary goal at Novartis Animal Health. Guidelines
we recommend to veterinarians include:
1) Examine all dogs before prescribing any medication, including
2) Conduct appropriate laboratory tests in dogs that may
be at risk including:
a. senior pets
b. pets with history of liver disease, inflammatory bowel
disease, renal disease or any other chronic condition.
3) Evaluate potential drug interactions in dogs being treated
medications, especially steroids or other NSAIDs.
4) Observe appropriate washout periods when switching from
one NSAID to another or when following corticosteroid use
with NSAID therapy. The length of the washout period will
vary, depending upon the patient’s condition and other
5) Establish baselines and periodically monitor hematology
and serum biochemical data in long term patients.
6) Provide pet owners with the Deramaxx Owner Information
sheet included with each Deramaxx product shipment and share
all potential benefits and possible side effects with them
before sending them home with Deramaxx. (Note: Veterinarians
can order updated veterinary inserts and updated client
information sheets free of charge at any time by calling
1-877-PET-LIT-1 and requesting item number DER 030041B for
the revised veterinary insert or item number DER020046B
for the revised client information sheet.)
7) Advise pet owners to watch for early signs of drug intolerance
including vomiting, diarrhea and lack of appetite, and if
they see the signs, discontinue use immediately and contact
We trust you will find this information on Deramaxx useful
as you continue to expand your knowledge and experience in
pain and arthritis management. Please share this letter with
associates in your practice, and contact Novartis Professional
Services at 1-800-637-0281 if you have questions about Deramaxx
or any other Novartis product.
David Stansfield, BVSc, MRCVS
Director, Professional Services
Novartis Animal Health US, Inc.
John Cary, MS, DVM
Novartis Animal Health US, Inc.
(1) Data on File, Novartis Animal Health US, Inc.
* NADA #141-203 Approved by FDA