Rimadyl/Deramaxx/etc. TAKE ACTION Page

Is your dog having an adverse reaction to Rimadyl or another NSAID (non-steroidal anti-inflammatory drug)?  Review these signs:

Signs of a Potentially Life-threatening Reaction to Rimadyl, Etogesic, Metacam, Deramaxx, Previcox, Zubrin, Novox, Vetprofen

  • loss of appetite
  • change in drinking habits (refusal to drink or increased water consumption)
  • unusual pattern of urination, blood in the urine, sweet-smelling urine, an overabundance of urine, urine accidents in the house
  • vomiting
  • diarrhea
  • black, tarry stools or flecks of blood in the vomit
  • lethargy, drowsiness, hyperactivity, restlessness, aggressiveness
  • staggering, stumbling, weakness or partial paralysis, full paralysis, seizures, dizziness, loss of balance
  • jaundice (yellowing of the skin, mucus membranes and whites of the eyes)

IMPORTANT SAFETY INFORMATION FROM THE MANUFACTURER OF RIMADYL: As a class, NSAIDS may be associated with gastrointestinal, kidney and liver side effects. These are usually 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 RIMADYL. Use with other NSAIDS or corticosteroids should be avoided. See full Prescribing Information.

Ten Steps to Take If You Suspect Your Dog Has Had an Adverse Reaction to Rimadyl or Another NSAID

(1) If you see any of the above-listed signs of adverse reaction, immediately stop the drug and take your dog to the vet. The earlier your dog gets appropriate treatment, the better the chances of complete recovery.

(2) Take with you to your vet a print-out of the Rimadyl Owner Information Sheet (OIS) and the package insert: Rimadyl package insert.   Deramaxx insert is at this link.  If using another NSAID, use a search engine to locate the OIS or package insert.

(3) Get to a veterinarian right away, if your dog seems seriously ill.  If you cannot get an immediate appointment with your usual vet, go to the nearest emergency veterinary clinic. If the veterinarian who sees your dog maintains that it’s not possible your dog is having a reaction to Rimadyl or another NSAID, produce the materials you’ve printed out; these describe the reactions that you have observed in your dog. If you meet resistance, insist that the veterinarian carefully review these materials and explain again that you believe your dog is having a reaction that is typical of a dog taking a non-steroidal anti-inflammatory drug (NSAID). Misdiagnosis is frequent in cases of an  NSAID reaction. DO NOT ACCEPT a diagnosis of any other condition (cancer, for example — a frequently-cited misdiagnosis), until an adverse reaction to an NSAID has been thoroughly ruled out.

(4) Ask your veterinarian to call the manufacturer to consult on the tests and therapy your dog needs. The staff veterinarians should be able to offer guidance:

Pfizer/Zoetis (Rimadyl): 1-800-366-5288

Elanco (Deramaxx): 1-888-545-5973

Usually a blood panel and CBC (complete blood count) are needed. Therapy will vary, depending on which organs have been affected.

(5) Don’t panic! If you have caught your dog’s potential adverse reaction to the NSAID in time, it is unlikely that the outcome will be fatal.

(6) Log onto the support network for people whose dogs have experienced an adverse reaction to Rimadyl: B.A.R.K.S. Support Group (BARKS: Be Aware of Rimadyl’s Known Side-effects) Members of this group represent a wide variety of experience in types of side effects, therapies that work, and getting help from your veterinarian and from Pfizer.

(7) Follow up with the manufacturer to be sure they have recorded the report from your veterinarian and to ask any and all questions you may have:

Pfizer/Zoetis (Rimadyl): 1-800-366-5288 

Elanco (Deramaxx): 1-888-545-5973

(8) If your dog dies, and it becomes necessary to establish whether the NSAID was a factor in the death, a necropsy must be performed. The necropsy does NOT have to be done by a veterinarian appointed by the manufacturer; it should, in fact, be done by an impartial third party. However, the manufacturer should be advised promptly that the necropsy is being undertaken and that they will be entitled to some, but not all, of the tissue samples obtained.

 

(9) Try to maintain a diary of the events leading up to your dog’s suspected adverse drug reaction. Make it as detailed as possible. Also obtain all medical records from all sources. Your diary and these records will be invaluable, should you decide to apply to Pfizer for reimbursement of veterinary medical expenses.

(10) Contact and have your veterinarian contact the FDA’s Center for Veterinary Medicine to report the incident.

How to report to the FDA:

  • by telephone at: 1-888-332-8387 (or 1-888-FDA-VETS)
  • via the FDA website
  • or go directly to the form )
    Once you print out the form, just complete it and mail it. It is postpaid.

According to the FDA:

“In common terms, an adverse drug experience (ADE) is either an undesired side effect, or the lack of a desired effect. The Center for Veterinary Medicine (CVM) defines an ADE as ‘any side effect, injury, toxicity, or sensitivity reaction (or failure to perform as expected) associated with use of an animal drug, whether or not determined to be attributable to the drug.’ ” This means that you need only SUSPECT that the side effect is caused by the drug; you do not have to prove it.

If you decide to report an ADE , the FDA advises as follows:

“You should first call the drug company. Inform them that you wish to report an ADE, and ask to speak to a technical services veterinarian. The technical services veterinarian should ask a series of questions about the experience, complete a form called the FDA 1932, and forward the report to CVM . We suggest the drug company as your first point of contact because many companies will also offer clinical advice or diagnostic assistance. CVM does not provide these services. If you wish to confirm that your report was forwarded, or prefer not to call the drug company, call CVM directly at (888) FDA-VETS. Please ask to speak to one of the veterinarians responsible for the ADE monitoring program.”