15 June 2015
09 Dec 2016 BRAVECTO Chewable Tablet Statement
Media statement Bravecto
Many of us at MSD Animal Health are pet owners and veterinarians and do what we do because of our love for animals. We understand the significant bond between pets and their owners and a pet’s health and well-being is our top priority.
Recently, there have been misleading reports in social media that may have some pet owners concerned over the safety and efficacy of BRAVECTO (fluralaner) Chewable Tablet (BRAVECTO). It’s important that we correct the record and share the facts about the product’s strong safety and efficacy profile.
First, the safety of BRAVECTOhas been documented in more than 55 clinical research trials.These clinical trials were the basis for the approval of BRAVECTO by 72 regulatory agencies around the world. Each of these regulators have affirmed, and continue to affirm, that BRAVECTO is safe and effective for use as indicated in the label. BRAVECTO is one of the few veterinary treatments that regulators have approved for use in breeding, pregnant and lactating dogs, which is another indicator of its strong safety profile. The veterinary community and the pet owners it supports has embraced the safety and efficacy profile of this product by dispensing it in more than 34 million doses since it was first approved for sale in 2014.
With regard to the 34 million doses that have been administered, we are required by law to report all adverse events to the governing regulatory agency whether they were linked to the product or not. We do this so that accurate safety and efficacy information is available for veterinarians prescribing our products. Once we have submitted adverse events, the European Medicines Agency, and regulatory agencies around the world conduct a robust review of the adverse event reports. Results of the review are reflected in our approved BRAVECTO label and we have every confidence in the safety of the product as reflected in that label.The EMA’s latest conclusion,9 September 2016,on the Periodic Safety Update Report (PSUR) for BRAVECTO is published.
To reiterate, as a responsible animal health company, we take reports of potential adverse events seriously and investigate thoroughly. We work with pet owners and attending veterinarians to assemble the available information to gain an understanding of every case to help determine the cause of a pet’s health issue. It is important to note that a pet may be on multiple medications or have other illnesses or pre-existing conditions. The adverse event may be related to these other factors and not to BRAVECTO.
We believe it is vitally important to be transparent with our customers about important safety information. Where the available data do warrant inclusion on the label, we work with regulators around the world to ensure appropriate inclusion.