Has Sammy been taking Deramaxx for too long?

Now I have to worry for the medication that we have been giving Sammy. Apparently, the Deramaxx is not as safe as advertised, or at least it has the risk of complications if taken more than 7 days as post-surgery medicine.

http://www.usatoday.com/money/industries/health/drugs/2005-04-11-dog-pain-usat_x.htm
http://network.bestfriends.org/newyork/news/4001.html
http://www.dogsadversereactions.com/nsaid/memorial22.html
http://www.dogsadversereactions.com/nsaid/internetreaction.html
http://www.caberfeidh.com/Pain3.htm
http://www.cafepharma.com/boards/archive/index.php/t-27329.html

There's a lot of misinformation going around, I am sure, but there are also a lot of reasons for not trusting pharmaceutical companies.

I found the following in the study that Novartis posted with the FDA (http://www.fda.gov/cvm/FOI/141-203.pdf).

"Results of the study demonstrate that DERAMAXX™ Chewable Tablets are safe and effective when administered at a dose of 3-4 mg/kg of body weight once daily for a maximum of 7 days."

We have been giving the drug to Sammy for a month!!! The surgeon in Bellevue gave us more Duramaxx, and he also changed it from half 100 mg to one 75 mg, so he actually raised the doses.  

From: http://www.dog-arthritis-resource.com/deramaxx-warning/

"It took 11 months for Novartis to even begin to comply with FDA regulations, yet at the same time they were able to obtain permission to market their product to an even wider market. Does this seem logical to you? Is it any wonder that so many people are afraid to trust drug companies to do what is in the best interest of their dog? When you consider that the FDA actually receives less than 1% of serious ADE reports, it really puts things in perspective.
As of January 3, 2005 the FDA released the following numbers:

Deramaxx Reviews: 2352

Treated: 2400
Reacted: 2371
Died: 515

This number is staggering. More than 20% of the dogs died after being administered Deramaxx. The number is even scarier when you consider the amount of cases that go unreported."

This is the data directly from the FDA (http://www.accessdata.fda.gov/scripts/animaldrugsatfda/details.cfm?dn=141-203):

Sponsor: Novartis Animal Health US, Inc.

Ingredients: Deracoxib

Exclusivity: Granted for the additional claim of control of pain and inflammation associated with osteoarthritis in dogs. No product using deracoxib as an active ingredient has been previously approved for use in dogs in any other application.

Specifications: Each chewable tablet contains 25, 50, 75, or 100 milligrams (mg) deracoxib.
Conditions of use: Dogs, weighing more than 4 pounds. Amount: 3 to 4 mg per kilogram (1.4 to 1.8 milligrams per pound) of body weight once daily for up to 7 days, given orally.

Indications for use: For the control of postoperative pain and inflammation associated with orthopedic surgery in dogs weighing 4 or more pounds (1.8 kilograms).

Amount: 1 to 2 mg per kilogram (0.45 to 0.91 milligrams per pound) of body weight once daily as needed, given orally .

Indications for use: For the control of pain and inflammation associated with osteoarthritis

So, since Sammy weights 90 pounds, the doses for postoperative pain would be 126-162 mg and for control of pain 40.5-82 mg. We have been giving him 50 mg (half of a 100 mg tablet) and recently 75 mg. I am going to consult with the veterinarian tomorrow to see if I should stop it completely or reduce the doses.

Andres.