Petitioning Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine at the FDA and 3 others

Bravecto (flea & tick treatment) should be removed from the market WITHOUT DELAY!!!!

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We are petitioning for Bravecto to be removed from the market.  Ever since a social media post about Bravecto went viral in June 2015, controversy around this product has not stopped increasing. And neither have the amount of Bravecto related side effects, adverse reactions and deaths. 

In spite of numerous reports filed with Merck/MSD, the FDA and other government agencies, this issue is not being addressed properly.   It is now time to take action. Please do the right thing by signing this petition. We need this drug to be withdrawn from the veterinary scene with immediate effect since side effects can be severe.

The following Facebook page was started to raise awareness to the side effects.  Please join if you have not already.  If your dog has experienced side effects, they can help you report them to MSD/Merck.

Here is a link to the facebook group Does Bravecto Kill Dogs ? https://www.facebook.com/groups/411371212394679/

While the incidence of side effects is reported to be low (due in part to most dog owners not reporting the side effects that their dogs were subjected to), the severity of side effects is concerning.  There are many reports of severe pancreatic issues including bloody vomit and diarrhoea.  Additionally, reports of seizures, skin issues, and kidney failure are reported worldwide.

Many of the side effects have been very serious and needed veterinary treatment sometimes costing the owners thousands to treat to try and save their dogs.  As of the end of June 2016, the European Medicine Agency reports include, besides multiple general short lived side effects, also approximately 2000 serious cases of adverse reactions from Bravecto such as seizures, renal failure, liver damage, etc, including 470 deaths.  But please note: these numbers are most likely heavily understated since the FDA estimates that approximately 1% of all side effects on drugs are actually reported. In my opinion, reasons for this tendency usually include the fact that not many people know that they can report the reactions and if they do know, they do not know how to go about it. Should you need help in reporting any reaction to Bravecto, including the death of your furkid, please visit the Facebook group "Does Bravecto Kill Dogs?" by following the link provided below, and we will help you with pleasure to file your report.

Once given to your dog Bravecto stays in the system for at least three months. There is NO ANTIDOTE AVAILABLE. 

Here are links to the FDA reports of side effects http://yourpetsneedthis.com/

http://yourpetsneedthis.com/wp-content/uploads/2015/11/Bravecto-fluralaner-ADE-report.pdf

http://yourpetsneedthis.com/wp-content/uploads/2016/01/Bravecto-fluralaner-ADE-report-Jul2015-Jan2016.pdf

Here is a link to some cases of side effects of dogs which had seizures, some of which resulting in death https://www.facebook.com/groups/411371212394679/permalink/464664963731970/

This is a link containing information on actual cases reported by MSD and information about the study done for approval.  While MSD states the testing was extensive, the study for FDA approval was done on slightly more than 200 dogs:

https://www.facebook.com/groups/411371212394679/permalink/471496659715467/

Here is a link to a you tube video that contains pictures of that have suffered side effects or death after taking Bravecto https://www.youtube.com/watch?v=AZ1IPMMoZ6U&feature=share

The following breeds are included in the reports received from the European Medicine Agency:

Alaskan Malamute (6) Akita (4) American Bulldog (4) American Cocker Spaniel (8) American Eskimo Spitz (5) American Staffordshire Terrier (2) Australian Cattle Dog (6) Australian Shepherd Dog (23) Australian Terrier Australian Kelpie, Basset Griffon Vendeen Basset Hound (5) Beauce Sheepdog - Beauceron (2) Beagle (20) Bearded Collie (3) Berger De Brie - Briard (3) Belgian Shepherd Malinois (5) Belgian Griffon Bernese Mountain Dog (9) Bichon Frise (17) Border Collie (31) Border Terrier Borzoi Boston Terrier (9) Boxer - German (35) Brittany (4) Bulldog (4) Bullmastiff Bull Terrier (6)Cairn Terrior (11) Cavalier King Charles Spaniel (20) Chesapeake Bay Retriever Chin Chihuahua (34) Collie Rough Corso dog (2) Continental Toy Spaniel Papillon (7) Coton De Tulear (3) Chow Chow (4) Dachshund (standard) wire haired (2) Dachshund (standard) smooth Dachshund (standard) long haired Dalmatian (3) Doberman (9) Dogo Argentino Dogue De Bordeaux (2) English Bulldog English Cocker Spaniel (10) English Setter (6) English Springer Spaniel (9) English Toy Terrier (10) Flat Coated Retriever (6) Fox Terrier Smooth French Bulldog (20) French Spaniel French Wire Haired Pointing Griffon (2) German Shepherd (46) German Short Haired Pointing Dog (3) German Spitz Pomeranian (16) German Hunting Terrier (2) German Wire Haired Pointing Dog Giant Schnauzer (3) Golden Retriever (46) Great Dane (6) Greyhound (6) Hovawort (3) Human - Yes Human - (25) Hungarian Short Haired Pointing Dog - Visla Irish Red and White Setter Irish Soft Coated Wheaton Terrier (2) Irish Glen of Imaal Terrier Italian Greyhound Jack Russell Terrier (28) Japanese Spitz (2) King Charles Spaniel (3) Kuvasz (2) Lancashire Heeler Labrador Retriever (115) Large Münsterländer  Lhaso Apso (14) Maltese (14) Mastiff (5) Medium size Poodle Miniature Dachshund (14) Miniature Pinscher (6) Miniature Poodle (12) Miniature Schnauzer (24) Münsterländer Neapolitan Mastiff (2) Newfoundland (3) Norwegian Buhund Norwegian Elkhound Grey (2) Norwegian Forest Nova Scotia Duck Tolling Retriever (4) Old English Sheepdog (2) Pekingese (7) Polish Lowland Sheepdog Portuguese Water Spaniel Pug (16) Pyrenean Mountain Dog (3)Rhodesian Ridgeback (2) Rottweiler (14) Saint Bernard (5) Scottish Terrier (2) Schnauzer (4) Shetland Sheepdog (5) Shar Pei (4) Shiba Inu (2) Shih Tzu (34) Siberian Husky (15) Small Münsterländer (2) Standard Poodle (30) Staffordshire Bull Terrier (8) Tibetan Mastiff Tibetan Spaniel Tibetan Terrier (3) Toy Poodle (6) Weimaraner (5) Welsh Corgi Cardigan Welsh Corgi Pembroke (3) Welsh Springer Spaniel (2) Welsh Terrier West Highland White Terrier (12) Whippet (2) Yorkshire Terrier (61)

The following countries have reported:

United States, Canada, Australia, Austria, Belgium, Brazil, Chile, Columbia, Czech, Denmark, Finland, France, Germany, Grenada, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Slovenia, Sweden, South Africa and United Kingdom.

At this point it should be stressed how important it is for everybody who has had a bad experience with Bravecto that you should report the incidence to MSD (Merck) and the FDA (in the USA) or the appropriate authority for the regulation of veterinary medicine in your own country if you do not live in the USA. In Europe the authority is the European Medicine Agency. Also report it to your vet, who will then file a report. The more cases are reported, the higher the percentage will become. We need this drug removed from the shelves, and it will be so much easier to motivate why it should be removed if everyone whose dog became ill or died because of Bravecto does in fact report it. The ideal would be if 100% of all cases are reported but the sad reality is that only about 1% of all cases are reported. That is the ground used by Merck to state that incidences of adverse reaction is "rare" and "mild", while we know that exactly the opposite is true. They also do not mention the severity of the cases and the length of the time period that symptoms last... Once again, should you need help to report a case, please visit this link: https://www.facebook.com/groups/411371212394679/permalink/473935296138270/?pnref=story

Photo features Rico in happier days: Courtesy of Mike Van De Sande, Rico's owner.

This petition will be delivered to:
  • Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine at the FDA
  • The European Medicines Agency
    The Committee for Medicinal Products for Veterinary Use (CVMP)
  • Director: Risk Management & Investigations, SA Dept of Agriculture
    Miss Liunda Pike
  • Deputy Director Investigations, South African Veterinary council


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