Zoetis Statement on Social Media Posts Mentioning Simparica® (sarolaner) Chewables
PARSIPPANY, N.J -- July 23, 2019 – Zoetis is aware of a video circulating on social media that references Simparica® (sarolaner) Chewables and a potential neurologic adverse event in a dog in the U.S. Since coming to the attention of Zoetis, the company has offered the following response to inquiries:
At Zoetis, we are committed to providing safe and effective products to veterinarians, pet owners and the animals in their care. Many Zoetis colleagues own pets themselves, and we can all sympathize with the frustration and concern that pet owners experience when their pets are sick. We have been in contact with the pet owner in this video to better understand the situation.
Simparica is one of four tick and flea medications for dogs in the isoxazoline class currently on the market. The labeling for Simparica is approved by the FDA. The product label and all related promotional materials 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, which has been sold in the U.S. for more than three years, remains an effective and safe tick and flea option for most dogs. The overall global reporting rate for any clinical sign reported for Simparica (including vomiting, lethargy, diarrhea, or any neurological sign) is classified as very rare as defined by international regulatory authorities as less than 1 report per 10,000 doses administered.* Simparica’s adverse event profile continues to be predictable and consistent with pre-approval studies and looks similar to other isoxazoline products on the market.
All medicines come with some potential risks and side effects and that is why their use should always be taken in consultation with a veterinarian. For the vast majority of pets, tick and flea medicines are safe, effective and help greatly reduce health risks that can come from parasites, such as anemia, Lyme disease and other infectious diseases. These are serious health concerns for all dogs and regular use of tick and flea medicines is recommended by veterinarians throughout the United States.
For more information about Simparica, including full prescribing information, click here.
*Notice to Applicants of Veterinary Medicinal Products, Volume 6C, Guideline on the Summary of Product Characteristics for Pharmaceutical Veterinary Medicinal Products, section 4.6.
IMPORTANT SAFETY INFORMATION
Simparica is for use only in dogs, 6 months of age and older. Simparica may cause abnormal neurologic signs such as tremors, unsteadiness, and/or seizures. Simparica has not been evaluated in dogs that are pregnant, breeding or lactating. Simparica has been safely used in dogs treated with commonly prescribed vaccines, parasiticides and other medications. The most frequently reported adverse reactions were vomiting and diarrhea. See full prescribing information at www.Zoetisus.com/SimparicaPI.
Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 65 years of experience in animal health, Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are
complemented by biodevices, genetic tests and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2018, the company generated annual revenue of $5.8 billion with approximately 10,000 employees. For more information, visit www.zoetis.com.