Dealing with a Negative Reaction to Deramaxx

This discussion is about a drug called Deramaxx,  a non-steroidal anti-inflammatory (NSAID) sold by Novartis Animal Health Products. If you haven't already, please read Side Effects of Deramaxx, The Problems with Deramaxx, and Using Deramaxx Safely.

STOP ADMINISTERING DERAMAXX^®. Get to your veterinarian as soon as possible. Because damage can be serious and immediate, any sign of NSAID toxicity should be treated as an EMERGENCY. Do not to wait to see how your dog does.

A full blood panel test should be obtained to determine whether there is kidney or liver damage. Stool and urine samples should be obtained to determine if there is blood in the stool (gastrointestinal hemorrhaging) or if the kidneys have been damaged (changes in the specific gravity of the urine).

Your veterinarian needs to review the case with the veterinarians at Novartis by calling 1-800-332-2761. Novartis veterinarians will help plan appropriate treatment, will log this reaction and will report it to the FDA’s Center for Veterinary Medicine (CVM) to help establish guidelines for the use of Deramaxx^®.

The CVM’s Dr. Hampshire notes that immediate, aggressive treatment can make the difference between life and death when warranted by blood tests and other signs of distress.

Simply stopping the drug is not enough in some cases. The drug must be cleared from the system as quickly as possible, as would be done with any poisoning. Further intervention with steroids and antihistamines may be required.

Tests and treatment can be expensive. Novartis has been generous in paying for both as a part of its program to monitor adverse reactions to the drug and collect as much information as possible about what caused the reaction.

Helping Others

Drugs such as Deramaxx^® are regulated by the FDA. Six full-time employees are monitoring reactions to Deramaxx, an unprecedented level of involvement by CVM in a new drug.

Without follow-up reporting by your veterinarian of what happened with your dog, including submitting copies of all laboratory tests and clinical notes on the case, vital information will be missing from the record. Novartis and the FDA rely on this record to ensure that Deramaxx^® is prescribed safely.

There are situations in which veterinarians have been at odds with pet owners over the cause of a reaction. Some  veterinarians may be concerned that they will be held liable for problems that arose after prescribing Deramaxx^®. In other cases, it is simply that in their medical judgment, they believe what happened was not linked to Deramaxx

Remind the veterinarian that the jury is not yet in on the safety of Deramaxx^®. It is best to consider all the possibilities until research and experience have clearly indicated what is and is not pertinent. Epidemiologic studies have documented that seemingly irrelevant information — even if it is counterintuitive — can end up being statistically significant. If data within the report ends up irrelevant, so be it. No harm will have been done. If data are dismissed as irrelevant at the outset and are not subjected to statistical analysis, none of us will be the wiser. The best science questions the obvious. Remind your veterinarian of this fact.

Novartis is not eager to attribute adverse events to Deramaxx^®, especially if the treating veterinarian does not see the link.

In these cases, it is a simple matter for owner to report the case directly to the FDA either by phone (1-888-FDA-VETS) or by filing a Form 1932 Adverse Event Report available on line at:

http://www.fda.gov/cvm/index/ade/adereporting.htm

CVM officials will take a report on your case and let you know what documentation they need and where to send it.

It is vitally important that the FDA get these reports backed with laboratory data and clinical notes so they can assess what steps are needed to protect our pets while providing them with pain relief.

Some of the information on this page has been freely provided by Vetnsaids.com.

The information provided here is not veterinary advice. It is presented on this site in order to provide information to pet owners so that they can make informed decisions when using Deramaxx. Pet owners should work closely with their veterinarian when considering using Deramaxx and discuss its possible side effects.

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