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FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events with Certain Flea and Tick Products

The U.S. Food and Drug Administration is alerting pet owners and veterinarians to be aware of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class.

The U.S. Food and Drug Administration is alerting pet owners and veterinarians to be aware of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class.

Posted on the FDA website 9/20/18:

The U.S. Food and Drug Administration is alerting pet owners and veterinarians to be aware of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class.

Since these products have obtained their respective FDA approvals, 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. Another product in this class, Credelio, 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 is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events because these events were seen consistently across the isoxazoline class of products.

The FDA carefully reviewed studies and other data on Bravecto, Credelio, Nexgard and Simparica prior to approval, and these products continue to be safe and effective for the majority of animals. The agency is asking the manufacturers to make the changes to the 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. Veterinarians should use their specialized training to review their patients’ medical histories and determine, in consultation with pet owners, whether a product in the isoxazoline class is appropriate for the pet.

Although FDA scientists carefully evaluate an animal drug prior to approval, there is the potential for new information to emerge after marketing, when the product is used in a much larger population. In the first three years after approval, the FDA pays particularly close attention to adverse event reports, looking for any safety information that may emerge.

The FDA monitors adverse drug event reports received from the public or veterinarians, other publicly available information (such a peer-reviewed scientific articles), and mandatory reports from the animal drug sponsor (the company that owns the right to market the drug). Drug sponsors must report serious, unexpected adverse events within 15 days of the event. In addition, they must submit any events that are non-serious, plus any laboratory studies, in vitro studies, and clinical trials that have not been previously submitted to the agency, on a bi-annual basis for the first two years following product approval and annually thereafter.

The FDA continues to monitor adverse drug event reports for these products and encourages pet owners and veterinarians to report adverse drug events. You can do this by reporting 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 (SDS) 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

If you prefer to report directly to the FDA, or want additional information about adverse drug experience reporting for animal drugs, see How to Report Animal Drug Side Effects and Product Problems.

Additional Information

Fact Sheet for Pet Owners and Veterinarians about Potential Adverse Events Associated with Isoxazoline Flea and Tick Products

Fast Facts

  • The FDA is alerting pet owners and veterinarians of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class.
  • The FDA-approved drugs in this class are Bravecto, Credelio, Nexgard and Simparica. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations.
  • Although these products can and have been safely used in the majority of dogs and cats, pet owners should consult with their veterinarian to review their patients’ medical histories and determine whether a product in the isoxazoline class is appropriate for their pet.

What should I know?

  • The FDA considers products in the isoxazoline class to be safe and effective for dogs and cats but is providing this information so that pet owners and veterinarians can take it into consideration when choosing flea and tick products for their pets.
  • Isoxazoline products have been associated with neurologic adverse reactions, including muscle tremors, ataxia, and seizures in some dogs and cats;
  • Although most dogs and cats haven’t had neurologic adverse reactions, seizures may occur in animals without a prior history;
  • Many products are available for prevention and control of flea and tick infestations. You can discuss all options with your veterinarian to choose the right product for your pet.

What products are in the isoxazoline class?

  • The FDA-approved drugs in this class are
    • Bravecto
    • Credelio
    • Nexgard
    • Simparica
  • These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations.

What should I do if my pet has an adverse drug event while using an isoxazoline product?

  • If your dog or cat experiences any adverse event while using an isoxazoline product, first consult your veterinarian.
  • The FDA continues to monitor adverse drug event reports for these products and encourages pet owners and veterinarians to report adverse drug events. You can do this by reporting 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 (SDS) 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
  • If you prefer to report directly to the FDA, or want additional information about adverse drug experience reporting for animal drugs, see How to Report Animal Drug Side Effects and Product Problems.
  • Pet owners and veterinarians who have additional questions can contact AskCVM@fda.hhs.gov or call 240-402-7002.

 

20 Comments

20 Comments

  1. Hope

    September 20, 2018 at 2:01 pm

    Thank you for caring so much for us and our pets to keep us informed Susan!

  2. Eileen Crosby

    September 20, 2018 at 2:08 pm

    You are a life saver Susan. Was on my way to the vet to get flea and tick treatments for my four dogs. God Bless you!!

  3. guest

    September 20, 2018 at 3:02 pm

    These pesticides have been killing pets for a long time. Finally enough pets have died, they are putting a notice out about it. Facebook gov owned site would remove any comments about pets dying or severe side effects from
    Bravecto
    Credelio
    Nexgard
    Simparica
    Big Pharma ….
    Merck Animal Health (Bravecto): 800-224-5318
    Elanco Animal Health (Credelio): 888-545-5973
    Merial (Nexgard): 888-637-4251
    Zoetis

    I called them before and they basically could care less about the severe suffering from their toxic pesticides. These are not medicines, they do not heal. These are toxic chemical pesticides.

    There are safe natural alternatives to repel fleas, ticks, etc
    Learn more at Dr Will Falconer at VitalAnimal.com

    Dr Will is the most honest true health veterinarian who will teach you the safe alternatives.

    • George

      September 22, 2018 at 10:28 am

      I am confused… Why should “Facebook gov owned site would remove any comments about pets dying or severe side effects ” ??? That doesn’t make sense to remove the warnings. Please explain.

  4. Cathy Lighty

    September 20, 2018 at 5:40 pm

    I gave my 12 pound chiweenie capstar last year and she ended up with acute kidney failure. She is doing well today, but she almost died. Now on K/D food the rest of her life, she was only 2 at the time and healthy. I won’t give her, nor will my vet give her flea meds, collars, etc anymore. Chemicals, pesticides, suck!!! They should take them all off the market!

  5. Thomas moriarty

    September 20, 2018 at 6:33 pm

    Our dog had seizures after taking flea and tick oral medicine. She is on medicine now to stop and control her seizures. The vets denied any correlation to the medicine when we questioned them about the possibility. Please be careful we watch our poor girl suffer through her seizures frequently. If it was safe we would use it for humans to control ticks.

    • Toni

      September 21, 2018 at 2:09 pm

      Thomas, try some CBD oil for your fur baby. It might help w/ the seizures and its not harmful.

  6. Evelyn Soria

    September 20, 2018 at 6:53 pm

    What’s safe for fleas/ticks then?

    • Carol

      September 24, 2018 at 7:20 pm

      Evelyn, here’s two alternative natural ways to keep fleas off your pets and out of your yard. I also use Mauro Flea & Tick shampoo and bathe my dogs every week.

      https://www.wondercide.com/

      https://www.amazon.com/DiatomaceousEarth-Food-Grade-10-Lb/dp/B00025H2PY

      You can buy these items on-line or in specialty pet stores. I doubt if Petco or Petsmart carries them since I haven’t shopped there in years!

      • kathy anderson

        May 7, 2019 at 10:25 pm

        tractor supply has the dirt, as does stores like Lowes I have seen the wondercide on a lot of livestock sites as I also have them.

    • Rosa

      February 9, 2022 at 9:10 am

      That is a great question. We live in a very rural area with lots of trees and the weather gets hot. Although my cats are indoor cats, sometimes we walk around outside for 30 minutes a day and fleas are terrible so I use the vet prescribed Bravecto [only 1 treatment only in the summer months]. I do not use it throughout the year because my cats are indoor cats. But now I am a little worried about using it in the summer months and would like an alternative

  7. airstreamingypsy

    September 20, 2018 at 9:24 pm

    My Border Collie got ill shortly after I got her a Serresto collar, lethargy and diarrhea, I took the collar off and she was fine within hours.

  8. J

    September 20, 2018 at 11:26 pm

    Are the adverse effects always Immediate or can they still occur weeks after the application?

  9. Pingback: Flea/tick med warning/ Isoxozoline - Maltese Dogs Forum : Spoiled Maltese Forums

  10. MARIA SGROI

    September 21, 2018 at 3:12 pm

    THE FDA SHOULD SHUT THEM DOWN!! THEY NEVER WILL THOUGH, IF THEY GET AWAY WITH KILLING PEOPLE EVERYDAY, WHY SHOULD THEY CARE ABOUT POOR HELPLESS ANIMALS!! AFTER ALL THEY CANT SPEAK!!!!

  11. Andi

    September 23, 2018 at 12:29 pm

    For my two dogs we use essential oils (product called Flea Flicker/Tick Kicker is great) and food-grade diatomaceous earth on their coats. We also bathe them every two weeks. BUT we also don’t walk them in the woods or allow them to run through any tall grasses or brush so their exposure to ticks is low. All of the preventive measures have worked well for us, but I know lots of people like to take their dogs hiking and camping and natural methods usually aren’t 100% effective.

  12. Kathleen Drippner

    September 24, 2018 at 12:15 pm

     I was diagnosed a year and a half ago with Lyme disease after three months of flu-like symptoms and severe knee and foot pain. Finally, after several tests and an expensive MRI, I was diagnosed. I was put on doxycycline and had a severe reaction to that, so then they put me on a different medication. My pain still didn’t go away for good. I still had bouts of pain and fatigue that last weeks. I was seeking something to help regain my life to be able to do things for myself. Through my primary physician i learnt about a Lyme disease herbal formula from NATURAL HERBAL GARDENS and their success rate with the treatment, i immediately started on the Lyme disease herbal protocol, I am glad to report the herbal formula worked effectively and there was no side effects, I had a total decline in symptoms, the pains, chronic fatigue and other symptoms stopped, my Lyme disease is totally REVERSED

  13. Sue Parr

    September 25, 2018 at 11:37 am

    Hartz over the counter flea treatments should be top of the list, even better taken off the market. So many pets have been killed and or injured with huge medical bills just to try to save them from using Hartz products! I almost lost my cat, watching her have seizures was frightening.

  14. Christine

    June 29, 2019 at 9:30 am

    Nexgard should be taken off the market. After 2 months my dog went into seizures and died. Its BS that these products still exist!

  15. angela audelo

    July 22, 2019 at 9:27 pm

    hartz is poison I cant believe it is being sold , my cat suffered horribly for months and once we realized what it was we felt horrible . I have bags of medicine from vets but cant bring mysekf to possibly poison them again.

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