FDA issues alert for isoxazoline class of flea, tick productsSeptember 21, 2018The 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 …
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FDA approves NexGard expanded label claimsAugust 22, 2018Merial, part of Boehringer Ingelheim, received approval from the U.S Food and Drug Administration to expand the label claims for NexGard (afoxolaner). The flea and tick control product is now approved to prevent Borrelia burgdorferi infections as a direct result of it killing Ixodes scapularis vector ticks, commonly called black-legged, or deer, ticks. NexGard is the first and only flea and tick product to receive FDA approval for preventing infections that cause Lyme disease by killing the vector ticks, the company stated. The approval comes just as veterinarians and pet owners in many parts of the country are being warned about the potential of an increased number of Lyme disease cases in 2018. The FDA approval is based on two well-controlled laboratory studies that showed that NexGard effectively prevented the transmission of B. burgdorfei infections after dogs were infested with wild-caught I. scapularis ticks 28 days after treatment with NexGard, said the manufacturer. "Both studies measured the transmission of B. burgdorferi to dogs after exposure to infected ticks," said Zach Mills, DVM, head of US Pet Veterinary Professional Services. "All dogs treated with NexGard tested negative for B. burgdorferi infection, demonstrating that transmission was prevented as a direct result …
