We at Doghealth2 are aware of the potential effectiveness of Rimadyl in controlling pain in dogs.  There are however, documented reports of adverse effects and death in dogs prescribed Rimadyl by veterinarians.  The Food and Drug Administration, Center for Veterinary Medicine has received complaints and veterinary documentation including , blood and urine values and autopsy reports, on dogs administered Rimadyl.  We are requesting that the FDA conduct risk assessments of potential adverse effects and death, using documentation provided by owners and veterinarians of dogs treated with Rimadyl.  For drugs to be safe and effective, those who develop drugs, pharmacologists, and those who administer drugs, veterinarians, must be aware that “one size does not fit all”.  We ask that FDA determine:

1.   The rate of adverse effects in treated dogs in comparison to all dogs administered Rimadyl

2.   Conditions which might predispose some dogs to experience adverse effects, decline and death, such as:  breed, age, existing health conditions, dose and length of time Rimadyl was administered, and provide a rating of more significant to less significant underlying conditions.

3.   If found, determine correlation between dose of Rimadyl and exposure time to onset of adverse symptoms

4.   Recommend effective treatment and administration time for dogs showing adverse symptomology from Rimadyl.  Determine most effective window of time for successful treatment of illness and decline due to toxicity.

5.  From autopsy reports determine organs most affected and cause of death, eg. cirrhosis or internal bleeding, etc.

and

6.   Establish requirements for veterinary prescription of Rimadyl including that all prescriptions must include the drug manufacturer's leaflet and the veterinarian should, in order to demonstrate responsibility in drug prescription and application, discuss the potential side effects of the drug being administered.  Discuss possible symptoms which should trigger the owner to seek additional care by the veterinarian. 

7.   FDA issue a formal report or publication of findings.

As stated in the FDA docket: Docket number 2004D-0468, “Draft Guidelines for Drug Sponsors on NSAIDS):  “The points above (as stated in Docket number 2004D-0468) have tragically resulted in a situation today that has genuinely reached crisis proportions : Tens of thousands of animals are being unnecessarily killed each year by side effects of drugs dispensed to them by veterinarians. They are dying unnecessary deaths which could have been, and CAN BE prevented, leaving legions of grief-stricken owners with no notion of how to cope with the death of their beloved animal friend in which they themselves unknowingly participated.”; Draft page 10 last two paragraphs.

And

Again As stated in the FDA docket: Docket number 2004D-0468: “Given the data heretofore mentioned which indicates : that veterinarians operate at the pharmacist level when dispensing drugs : that clients rarely, if ever, receive Client Information Sheets provided by the drug companies to the veterinarian; that veterinarians often and in usual practice purchase drugs in bulk and repackage them for client use; and that the FDA has no direct jurisdiction over vets who are regulated by State Veterinary Boards, it is recommended that NSAIDS be dispensed in approved and appropriately labeled containers only.” Page 14, fourth paragraph.

The request for a formal risk assessment of (any) drug safety by an impartial authority, beyond drug manufacturer's assurances, requires no explanation.