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[e-mail copy received 1/03/05] 

Center for Veterinary Medicines (HV-114)
Food and Drug Administration
Rockville, Maryland
(Dr. Linda Wilmot)
 
Dear Dr. Wilmot:
 
Tragically, my wife Jackie and I have joined the thousands of grief-stricken familles across America who have had their faithful companions ripped from our lives.  By the FDA's own estimates... there has possibly been over 50,000 deaths caused by what I now call "The Death Drug... DERAMAXX."  What is even more tragic and alarming is... that there are valid indications that to date, only a tiny fraction of these have been reported to you.  This is a national crisis!
 
As you can see below... Canyon was our magnificent, 114 pound, 8-year old male Doberman.  He was a beautiful and noble animal and treasure to the entire family, including Baye... our 2 1/2 year old granddaughter.  He was my constant and devoted companion of 8 wonderful years... a true "Velcro Dog."  He loved me... and I loved him.  He was an inspiration to me.  He trusted me.  On 19 December 2004, Canyon was killed by DERAMAXX, and I was his executioner.
 
 
Canyon

 

 
Baye kissing Canyon
 
Canyon watching over Baye
 
One of the last pictures of Canyon
 
 
On 8 December 2004, all was well at the Bowman Family.  Canyon was strong, healthy, active and happy.  Eleven days later he died a horrible death in my arms!  On 8 December... not knowing at the time, I made a fatal mistake by taking Canyon to my Vet for a very minor stiffness/lame condition.  And, due to a life-long habit of being raised on a farm... I trusted my Vet.  Never again.
 
The Vet prescribed one, 100 mg DERAMAXX tablet per day, for 14 days.  I had never heard of DERAMAXX.  The Vet did NOT provide ANY verbal or written information about side effects.  On Day 1, Canyon had a seizure with convulsions (first time ever).  I immediately called the Vet and discussed and asked if I should keep Canyon on DERAMAXX.  The Vet said "Yes."  Of all the times in my life where the little voice inside had wisely said "Don't do this"... for some reason... this time it did not speak.  As a result, over the next ten days I faithfully administered Canyon his pills with his evening meal.  Canyon would look up at me with his big almond eyes as if to say... "I'm ready for my pill, and if Daddy's giving it to me... it must be OK." Truth is, I betrayed him.
 
I learned too late that he would exhibit several of the KNOWN SIDE EFFECTS of toxic reactions to DERAMAXX. (Seizure, Diarrhea, Loss of Appetite, Dry Heaves, Excessive Drinking, Green Liquid stools, the Second Seizure and Death).  Side effects and reactions, that if I had known were linked directly to this drug, I would have IMMEDIATELY stopped giving it to Canyon.  With each of these reactions, he was trying to tell me he was dying.  Yet, taken individually on any given day, each one of these could be a normal occurrence.  However, not having been advised that I should be "connecting the dots" I did not see the relationship.  It was not until later that I learned on the day he died that Canyon had showed clear indications of massive internal hemorrhaging and kidney failure!  When Canyon collapsed and let out those horrible death screams... I almost went with him!  He should have NEVER died in such a terrible way!  He should have lived at least four more happy, healthy years.
 
Thinking at first that it was Cardiomyopathy (a heart attack), it was not until the day after Canyon died (YES... ONE DAY TOO LATE), that the little voice inside finally told me to search the Net on DERAMAXX Side Effects.  I was horrified with what I discovered!  I got very sick.  I found story after heart-breaking story of families just like mine who had lost their beloved pets.  They were now struggling with the grief and anger for NOT being told about DERAMAXX and the guilt of knowing they had played a direct role in the "execution" of their "Family Member."  For many... like myself... this has been a traumatic life-changing event!
 
On 3 January 05, I filed a Form 1932a, Adverse Drug Reaction Report.  I also called in the details on your 1-800-FDA-VET hotline, and later received a follow-up call back from Dr. Leanne Palmer at the Center.
 
I have "Picked up the Torch", and as a result of Canyon's wrongful death, I have made in contact with numerous suffering fellow Dobe-Lovers over the past month.  They are from all walks of life (Breeders, "Enlightened" Veterinarians, Medical Doctors, Attorneys, Pet-Owners, etc.) who like us, are devastated.  Drawing from our personal experiences... we are joining in collaborative effort to expose the truth about DERAMAXX and those who manufacture, distribute and dispense this hideous drug!
 
VIOXX and CELEBREX are the death drugs for humans, and we know that story.  What is NOT widely known is... that the equivalent Death Drugs in the animal world are RIMADYL and DERAMAXX
 
Hundreds of dogs have died on RIMADYL.  But, thank God there has now been a first-time-ever, landmark, legal-precedent-settting, class action suit that has been WON...  against the makers of RIMADYL.   Must we keep learning painful lessons over and over again?  Must we wait until hundreds (or thousands) more dogs have been killed on DERAMAXX?  NO!  THIS MUST STOP!!
 
Our Report is attached. Please discussed the contents of this Report as an agenda item at your upcoming meetings on:
 
DOCKET NUMBER 2004D-0468 DRAFT GUIDANCE FOR DRUG SPONSORS ON NSAIDS FOR USE IN ANIMALS AVAILABLE FOR REVIEW AND COMMENT
and
DOCKET NUMBER 2004N-0559 JOINT MEETING OF THE ARTHRITIS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE 
 
Page 21 through 27 of the Report lists proposed solutions and requests for specific action on the part of the Food and Drug Administration, Center for Veterinary Medicine.  Please do whatever is in your power to help put an end to these senseless and needless deaths. 
 
I have begun a letter-writing and "get the word out anyway I can" Canyon Crusade.  If you feel this issue is one that is NOT within the Center's ability to effect a satisfactory outcome... then please advise me as to who I might contact next.  (Some that I have on my list are:  State Veterinary Medical Boards?  University Schools of Veterinary Medicine? National Veterinary Medical Board? American Kennel Club? Doberman Pincsher Society? Newspaper and Radio Investigative Reporters? State Representatives? Senators? etc.?)
 
OK.  I'm going to sign off now.  Very late... Very tired... and Very Sad.   I would greatly appreciate your input.
 
Yours truly,
 
Buddy (and Jackie) Bowman
 
Dads and Moms Against DERAMAXX    (D.M.A.D)
 
PS:  To all others who may receive this message and Report:  Please help us spread the word.  Tell all your pet-owner friends to get fully informed about DERAMAXX.  It can literally be a matter of life and death!
 


Hello to all:  Aaargh!  Another late night at the keyboard!

 

I just submitted the following 3996-character blurb in the comments section for the FDA/CVM 2004N-0559 Meeting on 16-18 Feb 05.  I also attached my version (28 pages) of our Report and referenced my message (letter) to Dr. Linda Wilmot.  I hope it makes a difference.  :-)

 

As you can see, I tried to summarize step-by-step what went wrong and why it killed Canyon... and what to do about it.  My ADR had all the other info.

 

Good night!  Buddy

 

Canyon Bowman: Strong, healthy 114 pound Doberman

Born Oct, 1987 - Killed by DERAMAXX Dec, 2004

 

A bit strong for an opening statement? Maybe so... but accurate.

 

My ADR Report of 3 Jan 05, lists the following events: Day 1, Seizure. D2, Diarrhea. D4, Loss of Appetite. D8, Dry Heaves. D10, Excessive Drinking and Lethargy. D11, Green liquid stools, Violent Seizure and Death!

The following summarizes the critical issues that so needlessly cut Canyon’s life short:

 

1. DERAMAXX prescribed for a very minor stiffness condition.

-  Canyon did NOT have Osteoarthritis, nor was he recovering from orthopedic surgery! This extremely potent drug should not be prescribed in such a casual, incompetent way! Only for specific, unusual cases.

 

1. Dosage of one 100 mg tablet per day was on the HIGH end. Was not the LOWEST POSSIBLE effective dose!

-  If, as an absolute last resort, it is necessary to use this drug, it should be given at the LOWEST possible effective dosage. The tablets come with an indention for ease of “half tablet” 50 mg doses.

 

2. I was instructed (on the bottle) to give DERAMAXX to Canyon for 14 days!

-  He had a seizure the very next day after the first tablet! DERAMAXX should not be taken for more than 7 days! Require close daily monitoring and reporting. STOP at the first negative reaction. Damage has already occurred!

 

3. I received absolutely NO (written or verbal) warning, caution or explanation of possible negative side effects of using DERAMAXX.

-  This is the most crucial point... and this is criminal! There is authoritative information everywhere! Vets are, and should function as, the “intermediary.”

 

4. Canyon’s tablets were “repackaged” in a “Parkway Vet” container, and thus were completely void of manufacturer information on negative side effects.

-  Require specific counseling directly to every client… both verbal and written. Goes along with #3 above. Dogs are dying!

 

5. Failure to recognize the first and worse side effect… the first Seizure!

-  The most troubling:  Immediately following the Day 1 Seizure (first time

ever) I called the Vet and specifically asked if I should continue on DERAMAXX and I was told YES. Advice I will regret the rest of my life.

 

Once again, I received NO warning of anything to be on the lookout for. This exemplifies ignorance, incompetence and uncaring. Thus, in the next few days, it never occurred to me that each of the events listed above were clear accumulative indications of severe toxic reactions to this drug! I was progressively killing Canyon! Without warning, when considered separately, these events are somewhat normal (except for the first seizure!)

 

6. Dobermans have KNOWN reactions (allergies) to sulfa Drugs!

-  Find other alternative for easing pain for Dobermans… especially if it is only minor “aches and pains”.

 

7. To this day, Vet continues to deny any knowledge of problems with this drug!

-  Even after challenging the first the first day’s hasty assumption of death from cardiomyopathy and then discussing the above reactions related to DERAMAXX, the Vet denied any knowledge of problems with the drug! How can this be? This was not cardio. Canyon had an excellent EKC in Aug, 2003 and another (at my request) in Aug, 2004. How is it that I can learn more about the dark side of this drug in a couple of days on the Net than a Vet should have already known, and should have been bound by moral and ethical standards to share with me? Why does he deny knowledge? Something is very wrong here! I intend to know what.

 

What to do NOW, as a minimum:

 

1. Recognize this national crisis.  Direct immediate halt to further dispensing of this drug. Resume ONLY if and when valid tests prove its effectiveness and safety… for use ONLY in specific and unusual cases.

 

2. Mandate that State Vet Med Boards require Vets to accurately counsel clients BEFORE sending them home with DERAMAXX… if and when it ever returns to the market.

 

Other: My 2/3/2005 1:18:12 AM E-mail to Dr Wilmot


May my beloved partner ROMI rest in peace  - no matter wherever her bits and pieces/frozen carcass may be held hostage.

                            

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