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Pet Advocate 101

  • Letter to the head of Wyeth Pharmaceuticals regarding a clinical trial being conducted in Ghana to test whether moxidectin can inhibit the production of the parasite associated with river blindness - July 31, 2008
  • Letters to FDA Commissioner von Eschenbach in regard to adverse events linked to the the ProHeart 6 canine heartworm treatment - June 25, 2008
  • Letter Requesting Documents
  • Letter Requesting Information
  • Congress Questions Return Of Wyeth Dog Drug
  • Our view on drug safety: FDA vet tracks dog deaths, gets smeared in the process
  • Sen. Grassley’s letter regarding the FDA, a pharmaceutical drug maker and a safety officer at the FDA
  • Watchdog risked career over pet-drug warning
  • CVM's Notice of Regulatory Activity Letters to Pharmaceutical Companies
  • Sen. Charles Grassley, possibly the least colorful but most tenacious member of the Senate
  • Canada Moxidectin Slideshow: ProHeart 6 and the Media

  • Grassley Continues to Press FDA on Handling of Hampshire Case
  • Letter attachment No. 1
  • Letter attachment No. 2
  • Relevant document No. 1

  • Grassley Outlines Problems at FDA, Urges Reform - September 20, 2006
  • Spotlight - A Conversation with GAP President Louis Clark - Victoria Hampshire (See page 4 of this document)
  • Animal Drug Safety
  • Animal Drug Safety FAQ's
  • CVM Update - New Animal Drug Safety Page Posted on the CVM Website, June 22, 2006
  • Vioxx Debate Echoed in Battle Over Dog Drugs
  • Adverse Drug Experience Reporting
  • ADE Report Description
  • Glossary of Terms
  • Cumulative Veterinary Adverse Drug Experience (ADE) Reports NOTE: The ADE Summaries are broken into 6 alphabetical subsections to allow easier access to specific drug information. It takes between 8-11 minutes to download a one megabyte file using the average dial up internet connection. All the reports are displayed in Adobe Acrobat file format (.pdf).

  • 1987 to present - AC (2.5 MB)
  • 1987 to present - DF (2.32 MB)
  • 1987 to present - GL (1.8 MB)
  • 1987 to present - MN (2.18 MB)
  • 1987 to present - OR (1.35 MB)
  • 1987 to present - SZ (2.28 MB)
  • Reactions Reported to FDA
  • Canada: An Update on the Safety Evaluation of ProHeart®6 Sustained Release Injection February 2006
  • Floor Statement of U.S. Senator Chuck Grassley of Iowa - One-Year Anniversary of the Finance Committee’s Hearing on the FDA and Vioxx
  • UPDATE 1-US senator says Wyeth targeted FDA reviewer - November 17, 2005
  • ATTENTION PET OWNERS - Class Action Law Suit
  • The ProHeart Debate - VMAC sends mixed signals - April 15, 2005
  • Wyeth/FortDodge ProHeart 6 Safety Hearing
  • VMAC Meeting Transcript, 1/31/05
  • VMAC Statements/Speeches, January 31, 2005
  • Update - ProHeart®6 Injectable Heartworm Product for Dogs
  • Wyeth Heartworm Drug Not Proven Safe - U.S. Panel
  • "ProHeart®6 Class 1 Recall Internationally by Fort Dodge." - November 24, 2004
  • "Lawsuit Filed Against Manufacturer of ProHeart 6 Heartworm Medication." - September 27, 2004
  • APVMA RESPONSE TO THE RECALL OF THE VETERINARY MEDICINE ‘PROHEART 6’ IN THE UNITED STATES - September 10, 2004
  • Questions and Answers Regarding the FDA Recall of ProHeart®6, October 8, 2004
  • "FDA Talk Paper: Fort Dodge to Comply with FDA's Request to Recall ProHeart 6 Injectable Heartworm Product from the Market Due to Serious Health Concerns." September 3, 2004
  • "FDA Letter to Veterinarians: Important Drug Information about ProHeart6." September 13, 2004
  • Fort Dodge Letter to Vets, September 2004

  • "My major concern about using ProHeart 6 is not simply the dangerous potential side effects - all medications have potential side effects. It is the fact that these occur significantly more often when using ProHeart 6 than when using one of the many other equally effective heartworm preventatives currently on the market."  - "A Concerned Vet"

    Know the Facts about ProHeart 6
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  • Educational Flyers
  • Please share your dog's experience: Adverse reaction or No reaction to ProHeart6
  • Pet Wellness Media Blitz exposed by Pet Health News Alert free e-mail newsletter.
  • Proheart 6 back on track? - February 1, 2005
  • Vets and ProHeart 6 - Is it about the money? You decide.
  • Is ProHeart 6 Really Safe?A Vet Speaks Out.
  • Fort Dodge Recall Notice of ProHeart 6 April 27, 2004
  • Letter to Vets Regarding the product recall of ProHeart 6 April 2004
  • Dear Doctor letter to Veterinarians July 2002
  • Dear Doctor letter to Veterinarians June 2003
  • Dear Doctor letter to Veterinarians August 2003
  • FDA orders label changes for ProHeart 6
  • Proheart label 2001
  • Proheart label 2002
  • Proheart label 2003
  • Warning letter to Fort Dodge - March 31, 2004
  • On December 1-12, 2003 Food and Drug Administration (FDA) Investigators performed an inspection of your veterinary pharmaceutical manufacturing operation known as Fort Dodge Laboratories, Inc., located at 800 5th Street, N.W., Fort Dodge, Iowa 50501. This inspection revealed serious deviations from the current Good Manufacturing Practice...

    "The verdict is still out on ProHeart 6. Case documentation and research are in progress. To be safe - just don't use ProHeart 6. To be fair and the devil's advocate many, many, many, dogs have had the shot without consequences, however, there were dogs with blood clots in their lungs that were in oxygen tents - they are tragic - not where you want your dog to be."  - "Anonymous Vet"

    "When this drug was initially marketed, it was believed to be safe for heartworm positive dogs; then we found that dogs were dying that were heartworm positive," - - Dr. Victoria Hampshire, the FDA's adverse drug events coordinator.

    2/14/03

    I am indeed quite leery of the 6-month ProHeart shot.  At the conventional allopathic practice I work at, my colleagues do use it more than I certainly have, and, fortunately, I have yet to see a severe life-threatening reaction yet, although I do feel that there have been certainly a number of milder acute reactions.  I do feel that when you INJECT medications or vaccinations that there will always be those who react with sensitive immune systems, as by injecting things, you bypass all of the ways the immune system evolved to ward off microbes and other chemical invaders, which are unfortunately in the adjuvants of many injectables and vaccinations . . .

    The problem with this Fort Dodge shot is that there is no specific antidote to it, and once you inject the stuff, it's there for a minimum of 6 months . . . So if a patient is uniquely sensitive to it, then what is one supposed to do? 

    You see, the problem with all of these products and vaccinations is that they are not studied CHRONICALLY over months or years of use in either pets OR CHILDREN.  Their safety studies are done in a very limited population of individuals and for only short periods. There is no market in allopathic medicine for chronic safety studies done by INDEPENDENT researchers (not the drug companies), as they are too busy putting time, finances and resources in new drug development.

    I know several of my homeopathic colleagues have indeed seen life-threatening reactions to the ProHeart shot, and in my opinion, there should be a legal consent form required before a veterinarian does inject this stuff, as most veterinarians inject it while not citing any immune reactions, which Fort Dodge does acknowledge occur. - Michael Dym, VMD

    If you are aware of adverse reactions to veterinary drugs, please call the Center for Veterinary Medicine. Information about adverse drug reactions is critical to the CVM's on-going surveillance of animal drug products to assure their continued safety and effectiveness. You may report your experiences on a FORM FDA 1932a, "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report". The 1932a is pre-addressed, prepaid postage form that is completed and dropped in the mail. A form may be obtained by writing:

    ADE Reporting System
    Center for Veterinary Medicine
    U.S. Food & Drug Administration
    7500 Standish Place
    Rockville, MD 20855-2773

    You may also report adverse reactions by telephoning the Center for Veterinary Medicine at 1-888-FDA-VETS.


    DISCLAIMER:  This Web site is in no way affiliated with or sponsored by any pharmaceutical manufacturer or entity.  No pharmaceutical manufacturer or entity is responsible for this site or parts thereof.  The information contained herein is presented for the educational and free exchange of speech in relation to animal health and wellness issues only.  It is not intended as a substitute for the advice and/or treatment of a licensed professional.  We are NOT veterinarians.  Please consult your veterinarian for any medical problem of your companion animal.