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Hi Folks,

 To follow is an important message about the medication, Deramaxx, a drug prescribed for pain relief, and it’s IMPERATIVE that one READ about this medication BEFORE allowing one’s Companion to take it – dogs have become seriously ill and DIED after a single dose, see Ed's Web Site.

 All the Best,

Helen

 

* * * * *Permission is GRANTED to Forward to All Animal Lovers  * * * * *

 From Ed on DogHealth2 Group:

 Date: Thu, 10 Jun 2004

Subject: Deramaxx Product Label

 I just looked at the latest Deramaxx product label to see the new Post Approval Experience information which I think is an invaluable addition to the label and can't believe that the FDA has approved the following wording:

 "In RARE [emphasis added] situations, death has been reported as an outcome of the adverse events listed above."

 How can anyone familiar with the English language and basic math characterize death as "rare" when according to the FDA's own statistics death and euthanasia together constitute fully 21% of the reported Adverse Drug Events for Deramaxx? That makes death and euthanasia the third most commonly reported sign associated with Deramaxx after vomiting and anorexia.

 It seems to me that as a result of this wording, the product is now grossly mislabeled and veterinarians and owners are being horribly misinformed about the Post Approval Experience.

 I can only assume that the FDA's Center for Veterinary medicine assumes we don't read these labels and they can therefore get away with misinforming vet and owners.

 I think it is time we let them know this is NOT the case by emailing the acting commissioner of the FDA, Lester Crawford, DVM and the director of the Center for Veterinary Medicine, Steven Sundlof, DVM and letting them know that we find this to be a complete failure by the FDA to uphold the public interest.

 Their email addresses are:

 Lester Crawford, DVM D.Commissioner@fda.gov

 

 Stephen Sundlof, DVM SSUNDLOF@CVM.FDA.GOV

 

Ed Murray

Understanding Deramaxx

 

PLEASE CROSS POST FAR AND WIDE!

 

* * * * * * * * * * * * * *  * * * * * * *

 

"Understanding Deramaxx® Smart Drug or Clever Marketing? " The following is excerpted from Ed's Web Page:

"Silk, my 9 year old Dobie, injured her left rear leg and was prescribed Deramaxx® which she took for just two days. Needless to say, three days and $1,500.00 dollars later, the specialists are still giving her IV fluids. A scope was performed today by an internal medicine specialist who found that the entire stomach lining had been sloughed off. Her symptoms were violent vomiting which included blood, bloody stool and bleeding from the rectum. IV fluids will be maintained for at least two more days, which will make that a total of 5 days on IV fluids."    -------------Cheryl Hartman
 

As of March 14th, Cheryl's bill for treating Silk is now $3,470.53.

 

Signs of a problem

The main signs to be vigilant for are:

·         Vomiting

·         Change in bowel movements such as diarrhea or change in stool color

·         Change in drinking or urination

·         Decrease in appetite

·         Lethargy or aggressiveness

"All of the above signs could be related to other problems, but they are the first clues of a problem with Deramaxx®. At the first sign of any of these problems, stop administering the drug and contact your veterinarian.

Any degree of severity of the above signs warrants a blood test to determine whether there are signs of kidney, liver or gastro-intestinal impairment followed by appropriate treatment when necessary."

Hi Folks, 

To follow is an important message about the medication, Deramaxx, a drug prescribed for pain relief, and it’s IMPERATIVE that one READ about this medication BEFORE allowing one’s Companion to take it – dogs have become seriously ill and DIED after a single dose, see his Web Page .

 

All adverse events should be reported to the manufacturer and the FDA CVM [Center for Veterinary Medicine]:  

Telephone BOTH of these [regarding Deramaxx®]:

Novartis Animal Health 1-800/ 332-2761

    AND

FDA Center for Veterinary Medicine 1-888/FDA-VETS

[ 1-888/ 332-8387 ]

Also file an FDA form 1932a which is available online at the FDA link above.

 

  E-mail  Campaign -- you could be saving Dogs' lives!

"How can anyone familiar with the English language and basic math characterize death as "rare" when according to the FDA's own statistics, death and euthanasia together constitute fully 21% of the reported Adverse Drug Events for Deramaxx? That makes death and euthanasia the third most commonly reported sign associated with Deramaxx after vomiting and anorexia."      ---Ed

 

 

ã Copyright 1995-2004 Helen L. McKinnon All Rights Reserved

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