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Information for pet owners with concerns about new FDA labeling on Nexgard

Published: 10/3/2018

On September 20, the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) released a public health advisory regarding an important safety message that will be added to the labels of all dog and cat drugs in the isoxazoline class. This class include popular flea nd tick products such as Nexgard, Bravecto, and Simparica. 

What you should know:

  • The information that will be added to all isoxazoline labels identifies the potential for neurologic adverse reactions.

                         - The labeling for Nexgard Chewables has always included information about the potential for neurologic signs such as tremors, unsteadiness, and/or seizures that have been associated with use of it in some dogs. 

  • As is noted in the public advisory, the FDA-CVM carefully reviewd studies and other data on all isoxazolines prior to approval, and these products continue to be safe and effective for the majority of animals.
  • Nexgard, which is has been sold in the U.S. for more that 2 years, remains an effective and safe flea and tick option for dogs. 

                         - Nexgard's adverse event profile continues to be predictable, consistent with pre-approval studies, and looks similar to other Isoxazoline products on the market.

                         - The most commonly reported adverse events globally are:

                                            ~Vomiting

                                            ~Diarrhea

                                            ~Lethargy

 

Please click on the link to see the fact sheet provided by the FDA_CVM for pet owners. 

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