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FDA issues alert for isoxazoline class of flea, tick products

Discussion in 'Doberman Health and News Articles' started by strykerdobe, Nov 21, 2018.

  1. strykerdobe

    strykerdobe Hot Topics Subscriber

    You have to remember these are all Pesticides!

    FDA issues alert for isoxazoline class of flea, tick products



    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


    [​IMG]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.

    The FDA said it will continue to monitor adverse drug event reports for these products and encourages pet owners and veterinarians to report such events.

    Reports can be made to the drugs’ manufacturers, who are required to report this information to the FDA, or by submitting a report directly to the FDA.

    To report suspected adverse drug events for these products and/or obtain a copy of the Safety Data Sheet or for technical assistance, contact the appropriate manufacturers at the following phone numbers:

    • Merck Animal Health (Bravecto): 800-224-5318
    • Elanco Animal Health (Credelio): 888-545-5973
    • Merial (Nexgard): 888-637-4251
    • Zoetis (Simparica): 888-963-8471
    To report directly to the FDA or seek additional information about adverse drug experience reporting for animal drugs, see How to Report Animal Drug Side Effects and Product Problems.
     
  2. Tropicalbri's

    Tropicalbri's $ Premium Subscriber $ Hot Topics Subscriber $ Forum Donor $

    My two have reacted to the 3 (Bravecto, Simparica, Nexgard) with head tremors.
     
    • Empathetic Empathetic x 3
  3. strykerdobe

    strykerdobe Hot Topics Subscriber

    Did you report the adverse reactions to the FDA?
     
  4. Tropicalbri's

    Tropicalbri's $ Premium Subscriber $ Hot Topics Subscriber $ Forum Donor $

    Yes, the vet contacted each manufacturer.
     
    • Like Like x 2
  5. Tropicalbri's

    Tropicalbri's $ Premium Subscriber $ Hot Topics Subscriber $ Forum Donor $

    The vet I work for quit selling the Simparica because we had a lot of clients telling us about their dog’s side effects from taking it. Simparica has been the one we have seen the most reactions to at the clinic.

    Had a rep for Simparica come in and take Doc to lunch to get him to stock it again.
    Doc wound up having to pay for both their lunches because she ‘forgot’ her CC.
    To make up for the lunch she mailed a case of Simparica to the clinic. I got the privilege of returning it to her stating we still will NOT carry that product due to negative side effects our Client’s pets were experiencing.
     
    Last edited: Nov 21, 2018
    • Appreciation Appreciation x 1
  6. strykerdobe

    strykerdobe Hot Topics Subscriber

    Sounds like you have and work for a good Vet
     
    • Agree Agree x 3
  7. Tropicalbri's

    Tropicalbri's $ Premium Subscriber $ Hot Topics Subscriber $ Forum Donor $

    I am lucky in that all the info us techs research and share with him, he will research as well and implement into the clinic. We have designed a form for all the heart worm, flea and tick preventions and have designed it for each one of the products. We list the client and patient info, the product lot number and the side effect experienced by each pet.

    We do the same thing with our vaccines.
     
    • Like Like x 3

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