Bravecto Update
We know that many of you have questions about the Bravecto case reported several weeks ago on Facebook. First and foremost, please know that nothing is more important to Merck Animal Health than the safety and efficacy of our products, and the health and well-being of animals. We are confident in the safety of Bravecto.
Regulatory agencies in many countries around the world have consistently affirmed that Bravecto is safe for use as indicated on its label, and is one of the few new veterinary treatments to be approved around the world for use in breeding, pregnant and lactating dogs. Bravecto has been prescribed to millions of dogs around the world, and the frequency of adverse event reports has been rare.
As a responsible animal health company, however, we take every report seriously, investigate thoroughly and report any findings to the appropriate regulatory agency as required, which we did in this case. It’s important to note that even though a report is submitted, it does not mean there is a connection between the event and a product. With regard to reports, U.S. privacy laws and company policy prohibit the disclosure of details for any pharmacovigilance case. All case reports must remain confidential.
With regard to this matter, we can tell you that we have been working diligently with the pet owner and attending veterinarian to gather detailed information and are taking all measures necessary to bring this situation to resolution.
Thank you for your efforts in the field to help communicate with our customers about this matter and provided ongoing support for Bravecto.
IMPORTANT SAFETY INFORMATION: The most common adverse reactions recorded in clinical trials were vomiting, decreased appetite, diarrhea, lethargy, 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. For full prescribing information, click here.