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Which DRUGS are many Animal Lovers VERY Concerned about, and WHY?

 

December 1998 

They were our friends.  Our companions.  A part of the family. 

They were in pain.  They were prescribed carprofen (Rimadyl)

They were running again!  They were happy! We were delighted. 

Then they began to vomit.  And the diarrhea started. 

Some became jaundiced.  Others became lethargic. 

A different kind of pain set in.

                     THEN DEATH CAME. . . .

Our companion's adverse experience to carprofen (Rimadyl) and untimely death is considered to be "STATISTICALLY INSIGNIFICANT" by the cold-hearted. 

Statistics cannot measure the heartache and pain we feel over losing our friend. There is nothing insignificant about our loss and we refuse to let their deaths be labeled as such.

We know that before administering any drug, one must carefully weigh the benefits and the risks associated with that drug. 

It's quite an easy decision when you are told by our trusted veterinarian that the recommended drug has no side effects. 

As Stephen Fried so eloquently summarizes in his book, Bitter Pills"It's a question of whether the potential benefit is WORTH the risk and whether the patient UNDERSTANDS that risk- which depends on whether the doctor knows enough about the drug to really EXPLAIN the risk."

To become more informed about the side effects of carprofen (Rimadyl) and learn the tragic stories of our companions' deaths, visit The Senior Dogs Project website

Additionally, the 1997 Adverse Drug Experiences for carprofen are posted on the FDA's Center for Veterinary Medicine website .  There you will find a long list of reported reactions along with a tally of deaths

B. A. R. K. S. - Be Aware of Rimadyl's Known Side-effects.  The foregoing was written by Nancy Carr -

to accompany the first B.A.R.K.S. Poster of the "Rimadyl Dogs" - in 1998. 

Tragically the list of deaths continues to grow.

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To speak directly with a Pfizer representative about Rimadyl and your experience in your dog taking it, or discuss any other questions you may have, call:  800/ 366-5288

 

Hours: 9am -12noon and 1pm-5pm

Monday through Friday.

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More on Rimadyl


FDA CVM - Cumulative Adverse Drug Effect Report for the drug CARPROFEN (Rimadyl):  Introduced to the U. S. Market January 1997    Click Here for the entire report

January 31, 2004
Treated 12,680
Reacted - 12,278
DIED:   2,292 Companion Animals

Dec. 30, 2003
Treated 12,611
Reacted 12,209
DIED:   2,274 Companion Animals

November 28, 2003
Treated 12,507
Reacted 12,107
DIED:   2,255 Companion Animals

October 31, 2003
Treated 12,349
Reacted 11,950
DIED:   2,226 Companion Animals

Sept. 30, 2003
Treated 12,263
Reacted 11,871
DIED:   2,201 Companion Animals

Aug. 31 2003
Treated 12,241
Reacted 11,849
DIED:  2,193 Companion Animals

July 8, 2003
Treated 12,187
Reacted 11,805
DIED:  2,182 Companion Animals

June 4, 2003
Treated 12,089
Reacted 11,710
DIED:  2,153 Companion Animals

May 1, 2003
Treated 12,025
Reacted 11,650
DIED:  2,133 Companion Animals

 

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"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-- Click on the Link above to read more.

 

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ProHeart

 "Dear Doctor" Letter   excerpt  June 19, 2003

"...With regard to the label change, the following new statement, “and rare reports of death” has been added to the “Post-Approval Experience” section under the heading “ADVERSE REACTIONS”. The full section “Post Approval Experience” section now reads:

 

Please Click on the Link above to read more about this heartworm medication.

 

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Baytril®

FDA : Bayer's "Dear Doctor Letter" excerpt July 6, 2000:

"...Bayer Animal Health has received sporadic but an increasing number of reports concerning altered vision in feline patients treated with Baytril Tablets and/or Baytril Injectable...

Again, Baytril® (enrofloxacin) Injectable has only been approved for use in dogs. Discussion with your clients of potential side effects of any medication is always encouraged. We recommend you include in this discussion the potential for possible effects on the retina in cats treated with Baytril..."

 

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WHY is a FDA "DOCTOR'S LETTER" SO SIGNIFICANT?

"CVM is likely to ask the drug sponsor to make labeling changes or take other steps, such as sending a “Dear Doctor” letter to its client-veterinarians, if certain trigger points appear in the database. (To see “Dear Doctor” letters, go to CVM’s website and search using that term.)

For instance, if certain adverse experience signs show up frequently in the database, and the causality scores are in the possible-to-probable range, CVM officials are likely to contact the drug sponsor about label changes or other steps.

Also, if the scores are in the definite range and the adverse experience is severe, such as death, CVM officials are likely to ask the manufacturer to take some steps, even though the adverse events are not frequent.

Sometimes the ADE finding leads the company to revise the label—for instance to add safety warnings or to highlight information already there. And often the company will send out the “Dear Doctor” letter highlighting the change for veterinarians."

Please Click on the Link above to read more about this important "safeguard" for our animal companions.

 

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PLEASE, Report ALL Adverse Reactions !

 

Click Here for Info on Adverse Drug Experience Reporting

 

FDA Center for Veterinary Medicine -

Provides details of how to file an FDA form 1932a which is available online. 

You can designate that your name NOT be revealed to the drug manufacturer.

Adverse events can be reported over the phone by calling: 1-888/ 332-8387

"Veterinarians and animal owners are encouraged to report Veterinary Adverse Drug Experiences (ADEs) and suspected product failures to the government agency that regulates the product in question.

Pre-testing by the manufacturer and review of the data by the government does not guarantee absolute safety and effectiveness of approved veterinary drugs due to the inherent limitations imposed by testing the product on a limited population of animals.

Anyone with information to report is also encouraged to contact the manufacturer of the suspect product."
 

Contact The Center for Veterinary Medicine (CVM)

Division of Surveillance - HFV - 210,   7500 Standish Place,   Rockville, MD 20855

 1-888/ 332-8387
 

"The CVM [Center for Veterinary Medicine] established the hotline, (888) FDA-VETS, in 1996 to receive calls about adverse experiences to approved animal drugs."     

"We expected many of these reports to come from practicing veterinarians, but our review indicates that a majority of the calls in the past few years have come from consumers, particularly dog owners who find our link on the Internet."

------Dr. Victoria Hampshire

from the Journal of the American Veterinary Medical Assoc. (AVMA) FDA Surveillance News  January 15, 2004 [excerpt]

 

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Also, let your State Veterinary Medical Board Know !!

 

"The idea is to mail this [Sample Letter].... to each board member and ask that it be posted on their agenda for discussion... They, the board, and the vets, have nothing to loose over this common sense suggestion. We, the companion guardians have so much to loose...and already have lost.

You can also attach any stories you wish if you have permission from the author. Anyone can copy and use my Jetta's story from the Dogs Adverse Reactions website. If you need a plain copy, please let me know. We don't have too many shots at this as I've told some people. The manufacturers will keep making and selling their junk. The FDA is powerless over the vets...as I've been told directly by them. And the government officials are the biggest benefactor of the drug industry. That is why this is so important. By submitting this letter and the attachments to the board members, hopefully if they use their common sense and good judgment, they will see we have a problem, pass the regulations, and offer us some protection."

 

"Just enter your state and an address and contact will be displayed. I need to find the link for the board members yet. In PA, I was able to get a copy of their monthly news letter, which had all the board members named. If you can do that....great! I just forwarded copies to each person's attention at the board address. You could also call their number and ask for the board names as well."

Have your message be taken seriously.  The majority of the Board Members are veterinarians.  Avoid anger / hostility as you want them to take action - but not the kind that puts your letter in the wastebasket...


SAMPLE LETTER to send to Your State Board of Veterinary Medicine:

BACKGROUND: Certain drugs such as NSAIDs can have very serious side effects including gastro-intestinal ulceration and death.

Most of the serious adverse effects of these drugs could be prevented if:

1. Companion animals are properly screened for pre-existing conditions which will be aggravated by the drugs.

2.  Owners are given information about side effects that will allow them to watch for signs of problems and react to them before they become too severe.

PROBLEM: Too many vets fail to follow label instructions for screening animals with known risk factors for a drug and almost uniformly, fail to provide owners with the FDA-mandated and drug company provided Client Information Sheet.

This problem has become so severe that the Center for Veterinary Medicine of the federal Food and Drug Administration has published three articles (attached) bringing it to the attention of the veterinary community this year alone.

There are two aspects of this issue which are peculiar to the world of veterinary medicine:

1. Veterinarians act as pharmacists in both prescribing and distributing drugs, and

2. Unlike humans, companion animals cannot verbally notify owners when they are experiencing an adverse reaction which puts a premium on the owner being aware of potential adverse effects, information which is communicated in product label warnings as well as Client Information Sheets.

SOLUTION: Amend Section 31.21. Rules of Professional Conduct for Veterinarians,

Principle 8. Drugs, Chapter 31 (STATE BOARD OF VETERINARY MEDICINE), TITLE 49

(PROFESSIONAL AND VOCATIONAL STANDARDS) to require:

1. Pre-screening of companion animals prior to the administration or prescription of any drug for which pre-screening is advised or recommended on the product label.

2. Provide owners of companion animals copies of FDA-mandated Client Information Sheets for all drugs for which such sheets have been mandated.

 

 

 

ã Copyright 1995 Helen L. McKinnon All Rights Reserved

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