Elanco Animal Health (Credelio)

"Weve worked diligently to communicate the class change to veterinarians and also feature specific language on seizures in our Credelio advertisements. Also, FDA did not determine the final language re: seizure risk until after Credelio was approved. So, Elanco included the following language in the Credelio label with approval from the FDA: 'Use with caution in dogs with a history of seizures' at time of product approval."

"Nothing is more important to Merck Animal Health than the safety and efficacy of our products and the well-being of animals. We continue to encourage all pet owners to speak to their veterinarian before making any decisions about flea and tick control products. Parasites like fleas and ticks are not only a nuisance for pets and their owners, but if left untreated they can transmit serious diseases to pets.

It is important to note that the FDA updated the labeling for the entire class of isoxazoline drugs in September of 2018.

Pet-owner product materials, including advertising, displays and brochures have been updated with the new safety information.

Merck Animal Health is confident in the safety and efficacy of our products such as Bravecto and follow all legal and regulatory requirements. The safety and efficacy of Bravecto has been established through comprehensive research in more than 170 clinical research studies. In addition, more than 125 million doses of Bravecto have been distributed in 85 countries. The overall worldwide reporting rate for adverse events for our products containing isoxazoline remains classified as rare."

"In September 2018, the U.S. Food and Drug Administrations (FDA) Center for Veterinary Medicine (CVM) released a public communication to pet owners and veterinarians regarding the use of flea-and-tick-control products within the isoxazoline class of drugs. In this announcement, the FDA reported receiving reports of neurological signs in some dogs and cats following the use of products within the class. CVM issues these communications to veterinarians and pet owners to aid in making decisions about animal health products.

NexGard is an oral, beef-flavored soft chew that is administered monthly to dogs. It contains the active substance afoxolaner, a compound in the isoxazoline class, for the treatment and prevention of flea infestations and the treatment and control of ticks in dogs for one month. NexGard is approved by regulatory authorities for use in more than 100 countries, with more than 330 million doses sold worldwide. While the FDA notes that reports involving neurological signs have been reported for all isoxazoline products, they remain very rarely reported with NexGard (very rare defined as The most commonly reported adverse events in the US are vomiting, pruritus, lethargy, diarrhea, and anorexia. The NexGard label was updated with the information that the FDA described in their announcement.

The efficacy and safety of our products are paramount, and we believe that it is important for veterinarians and pet owners to be aware of any potential risks associated with products used in pets. As with any veterinary product, we recommend that pet owners discuss with their veterinarian before using a product."

"Zoetis colleagues, many of us pet owners, care about the well-being of pets, and we are committed to providing safe and effective products to veterinarians, pet owners and the animals in their care. We all sympathize with the frustration and concerns of pet owners when their pets are sick.

Our product Simparica (sarolaner) Chewables 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 of our 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.

Our product labeling for Simparica was approved by the FDA and updated in June 2019 to reflect their comments on neurologic events. Here is the website with prescribing and safety information for Simparica. You can click through from here for more detailed information that is shared in the packaging as well. https://www.zoetisus.com/products/dogs/simparica/prescribing-information.aspx

We are confident that Simparica, which has been sold in the U.S. for 4 years, remains an effective and safe tick and flea option for dogs. The overall global reporting rate for any clinical sign reported for Simparica (including vomiting, lethargy, diarrhea or any neurologic sign), is classified as very rare as defined by international regulatory authorities as less than 1 report per 10,000 doses administered (This rate was calculated based on all reports regardless of any causal relationship to the product). Simparicas adverse event profile continues to be predictable and consistent with pre-approval studies and looks similar to other isoxazoline products on the market.

We focus on ensuring veterinarians have the proper education, prescribing and safety information to share with pet owners, so that they can best advise each pet owner which products are the best choice for their individual pet and best suited to each pets medical needs. We also encourage pet owners to have regular conversations with veterinarians about their pets health.

Unfortunately, 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 Lyme disease, anemia 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.

Revolution Plus for cats is also an isoxazoline product (sarolaner) and was approved in the U.S. in 2018 and launched there in 2019. Simparica was approved in launched in the U.S. in 2016."

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Flea and tick medication companies respond to 5 On Your Side - WRAL.com