PARSIPPANY, N.J– July 27, 2022 – Zoetis is aware of a social media post originating on Facebook that references Simparica Trio® (sarolaner, moxidectin, and pyrantel chewable tablets,), a potential neurologic adverse event and the subsequent euthanasia of a dog in the U.S. Since coming to the attention of Zoetis, the company is offering the following response to inquiries:
At Zoetis, we are pet people, first and foremost. Committed to providing safe and effective products to veterinarians, pet owners and the animals in their care, we empathize with the frustration and concern that fellow pet owners experience when their pets are sick. We have been in contact with the pet owner who shared this post to better understand her pet’s situation, as well as other pet owners who have seen this post, listening to their questions and concerns. We take the reporting of any adverse event very seriously and our team works to understand each situation. With respect to the dog in the Facebook post, no conclusive diagnosis was made, as the dog was cremated, precluding a necropsy, which may have offered more of an explanation.
Simparica Trio protects dogs from heartworm disease, ticks and fleas, roundworms and hookworms, and it has been approved by the FDA as safe and effective. It is one of seven parasite prevention medications for dogs in the isoxazoline class currently on the market in the U.S. The FDA has published a factsheet reiterating that products in the isooxazoline class can and have been safely used in the majority of dogs. The factsheet, linked here, also contains information for pet owners and veterinarians to consider when choosing flea and tick products for their pets, including the risks associated with this class of products. The product label and all related promotional materials for Simparica Trio have always included information about neurologic signs such as tremors, unsteadiness, and/or seizures that have been associated with use of medicines in the isoxazoline class in some dogs.
We are confident that Simparica Trio, which has been prescribed to protect over 10 million dogs since coming to the U.S. market in 2020, remains an effective and safe parasite preventative option for most dogs. The overall global reporting rate for any clinical sign reported for Simparica Trio (including vomiting, lethargy, diarrhea, or any neurological sign) is classified as “very rare,” which is defined by international regulatory authorities as less than 1 report per 10,000 doses administered. * Simparica Trio’s adverse event profile continues to be predictable and consistent with pre-approval studies and looks similar to other isoxazoline products on the market.
As fellow pet owners and animal health advocates, we understand that when your dog is the one who experiences an adverse event, the statistics are a small consolation. Even so, the Zoetis team of veterinarians and veterinary technicians is deeply committed to listening to veterinarians and pet owners, addressing their needs to the best of their ability and diligently reporting all adverse events to the appropriate regulatory authorities, ultimately ensuring continued safe use of our products.
It is also critical to emphasize the importance of having a strong relationship with your veterinarian. All medicines come with some potential risks and side effects, and pet owners should weigh the potential risks and benefits in consultation with a veterinarian. For the vast majority of pets, parasite preventative medicines are safe, effective and help greatly reduce potentially fatal health risks that can come from parasites, such as anemia, Lyme disease, heartworm disease and other infectious diseases. These are serious health concerns for all dogs and regular use of parasite prevention is recommended by veterinarians throughout the United States.
For more information about Simparica Trio, including full prescribing information, click here.