Bravecto Safety Communication

Dear Veterinarian,

As you may be aware, BRAVECTO has received a lot of positive publicity as a result of our consumer advertising campaigns. Along with the positive accolades, there also has been some misinformation circulating, including a recent veterinary Q&A newspaper column that contained a question about the safety of BRAVECTO. As any of this activity may create some questions or concerns among your clients, we’re providing some information that will help support your communication with them. As always, if you have any additional questions, please don’t hesitate to reach out to your sales rep or the technical services veteriinarian in your area.

The Facts about BRAVECTO

Commitment: First and foremost, we feel it is important to state that there is nothing more important to Merck Animal Health than the safety and efficacy of our products, and the health and well-being of animals. Most of us are also pet owners and understand the significant bond between pet and their owners.

Safety: We are confident in the safety of BRAVECTO which has been prescribed to millions of dogs around the world. The frequency of adverse event reports has been classified as rare. Prior to introduction into the market place, the safety of BRAVECTO was established through comprehensive research and real-world use programs, as well as through extensive review after launch. As a standard company practice and in support of our commitment to continuous improvement, we maintain an ongoing evaluation of all of our products, including BRAVECTO, to continually reaffirm their safety and effectiveness.

Regulatory agencies in many countries around the world have approved BRAVECTO. In January 2015, the European Medicines Agency (EMA) reviewed all adverse events reported worldwide for BRAVECTO over the last six months, and the EMA continues to conclude that product performance is consistent with information provided on the label. BRAVECTO is one of the few veterinary treatments to be approved around the world for use in breeding, pregnant and lactating dogs.

Responsibility: As a responsible animal health company, we take every report of a potential adverse event seriously and investigate thoroughly. In every case, we make every effort to help determine the cause of a pet’s reported health issue, whether or not the product appears to be involved, and all findings are reported to the FDA. We do this in support of the veterinarians who prescribe our products, as well as the pet owners who use them.

Transparency: U.S. privacy laws and company policy prohibit the disclosure of details for any pharmacovigilance case. This means we are unable to share any details of a case, including health status, testing results and diagnosis. While many would prefer we share case information, we don’t do this — not only is it the law but we maintain a commitment to the privacy of veterinarians and pet owners, even if they choose to be more public about a situation.

Regards,

Kathleen Heaney D.V.M.

Technical Service Director, Companion Animal Business Unit Head

Merck Animal Health

IMPORTANT SAFETY INFORMATION: The most common adverse reactions recorded in clinical trials were vomiting, decreased appetite, diarrhea, polydipsia, and flatulence. BRAVECTO has not been shown to be effective for 12-weeks duration in puppies less than 6 months of age. BRAVECTO is not effective against lone star ticks beyond 8 weeks after dosing.

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