FDA issues alert for Bravecto, Nexgard and Simparica. Flea Tick products.

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FDA issues alert for isoxazoline class of flea, tick products
Potential exists for neurologic adverse events in dogs and cats when treated with isoxazoline class products
September 21, 2018
The U.S. Food and Drug Administration is alerting veterinarians and pet owners of the potential for neurologic adverse events in dogs and cats when treated with isoxazoline class flea and tick products, including Bravecto, Nexgard, and Simparica.

Data received by the agency as part of its routine post-marketing activities indicates that some animals receiving Bravecto, Nexgard, or Simparica have experienced adverse events such as muscle tremors, ataxia, and seizures, said the FDA in a statement. Credelio, another isoxazoline class product, recently received FDA approval.

These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations.

The FDA said it is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events, as they were seen consistently across the isoxazoline class of products.

These products continue to be safe and effective for the majority of animals, said the FDA, adding that it carefully reviewed studies and other data on Bravecto, Credelio, Nexgard, and Simparica prior to approval.

The agency is asking the manufacturers to change product labeling in order to provide veterinarians and pet owners with the information they need to make treatment decisions for each pet on an individual basis.