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FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events with Certain F

Discussion in 'Doberman Health and News Articles' started by strykerdobe, Sep 20, 2018.

  1. strykerdobe

    strykerdobe Hot Topics Subscriber

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    FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events with Certain Flea and Tick Products
    By Susan Thixton
    - September 20, 2018

    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.
     
    • Informative Informative x 3
  2. NikiL02

    NikiL02 Formerly Nlr02 $ Forum Donor $

    I wasn't too sure about Bravecto and still am not... It supposedly lasts for 3 months. That seems like a lot to put inside a dog to prevent fleas and ticks!
     
    • Agree Agree x 3
  3. Oh Little Oji

    Oh Little Oji Formerly Tad Hot Topics Subscriber $ Forum Donor $

    I heard something about this recently and like: Uh, ya' think?

    I don't want to be too flippant or ungrateful, but somehow I've never had a flea problem with my Dobes.

    I've used less and less in the way of preventative. I think with my previous boy I did no topicals, and if I recall, little or no oral preventative. With Oji, I have only used Wondercide any time I have been about to go to the dog park or venture into the woods or something. Oji has never had any preventative meds.
     
    • Like Like x 3
  4. NikiL02

    NikiL02 Formerly Nlr02 $ Forum Donor $

    It's not like fleas arent treatable if your dog does get them. Ticks can be a larger problem but I have never seen a tick in my life and I've lived in the woods!
     
  5. strykerdobe

    strykerdobe Hot Topics Subscriber

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    Dr. Jean Dodds' Pet Health Resource Blog
    Considered one of the foremost experts in pet healthcare, Dr. Dodds focuses on vaccination protocols, thyroid issues and nutrition.
    Visit Hemopet.org or Nutriscan.org for more information.
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    7th Oct 2018 | 1 note
    FDA Issues Warning about Flea and Tick Products
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    The US Food and Drug Administration (FDA) issued a warning on September 20, 2018 about the isoxazoline flea and tick products fluralaner for dogs and cats (Bravecto®), afoxalaner for dogs (Nexgard®), and saroloner for dogs (Simparica®). The recently introduced isoxazoline, lotilaner (Credelio®) for dogs falls into this same class.

    Dogs and cats with no known prior medical history of muscle tremors, ataxia, and seizures have experienced those adverse reactions to this class of flea and tick preventive pesticides. While the FDA is not pulling the four flea and tick preventatives off the market at this time, they will all have to carry an FDA warning on their packaging.

    Clinical, evidenced-based reports have been coming forward for the past several years and many studies are currently percolating about the reported adverse reactions to isoxazolines, synthetic pesticides. Dr. Jean Dodds is currently on a privately convened expert committee researching this topic and their report should be issued soon.

    Oftentimes when information such as this is brought to light, veterinarians and researchers can point to certain breed characteristics, age, drug interactions, or genetic mutations. For instance, dogs that are epileptic or prone to seizures should not have spinosads – a natural substance made by a soil bacterium that can be toxic to insects – that is also for treatment or prevention of fleas. Two of the most well-known spinosad products are Trifexis® and Comfortis®.

    Another example is the MDR1 gene mutation. This gene undergoes one or more mutations that allow a higher absorption of drugs and toxic substances to enter the central nervous system and then can breach the blood-brain barrier and create adverse reactions. Plus, we know that this gene mutation is most commonly found in dog breeds of herding breed ancestry. According to the Washington State Veterinary Clinical Pharmacology Lab, nearly three of every four Collies in the US have the mutant MDR1 gene. The frequency is about the same in France and Australia, so it is likely that most Collies worldwide have the mutation. The MDR1 mutation has also been found in Shetland Sheepdogs (Shelties), Australian Shepherds, Old English Sheepdogs, English Shepherds, German Shepherds, Long-haired Whippets, Silken Windhounds, and a variety of mixed breed dogs.

    This is where this can get tricky with the MDR1 gene mutation. FDA-approved antiparasitic drugs such as ivermectin (Heartgard), selamectin (Revolution), milbemycin oxime (Interceptor) and moxidectin (Advantage Multi; Proheart 6) have been tested and found safe for MDR1-affected dogs when given at the prophylactic heartworm preventative dosage level. Despite this commentary, the present author does not recommend several of these products, especially for toy and small breeds and puppies or those with or at familial risk for autoimmune disorders, including vaccinosis.

    Further, if a heartworm preventative is given with a spinosad, isoxazoline, ketoconazole, itraconazole, fluconazole or related antifungals, then serious drug-drug interactions can occur in dogs that have the MDR1 mutation.

    While we have known about the MDR1 mutation situation before, the scary part now about the isoxazoline class of drugs is that researchers and veterinarians thus far cannot point to breed characteristics, age group, drug interactions or genetic mutations as contributing factors to the latest findings that prompted the FDA warning. These adverse reactions to the isoxazoline class appear to be affecting pets randomly.

    As of May 4, 2018, 420 reports of worldwide adverse reactions to these pesticides in humans have been given to the European Medical Agencies (EMA). These reactions include breathing problems, skin conditions, and even seizures and the onset occurred after handling the chewable or spot-on treatment of fluralaner. Causality assessment at that time was placed at: 37 as probable, 13 as possible, 4 unclassifiable, 3 inconclusive, and the rest have not been assessed.

    What is possibly most concerning is the introduction of Exzolt®, which curbs red poultry mites. Red poultry mites can cause anemia, disease susceptibility and higher mortality rates in chickens. Exzolt® is made of the same isoxazoline (fluralaner), which is sold as Bravecto® for dogs and cats. The EMA recommended to the European Union to approve Exzolt® use through water treated with the product. As of September 2017, the product was being marketed in Europe. The withdrawal period for meat from chickens treated with Exzolt® is 14 days. The withdrawal period for eggs from chickens treated with Exzolt® is zero days, which means there is no mandatory waiting time.

    We have written extensively about the use of medications in livestock and how many of them can be passed up the food chain. We do not know definitively whether Exzolt® is passed up the food chain. Clearly, we believe that the EMA needs to reconsider its use.

    After a search on the FDA’s website for fluralaner, afoxolaner, sarolaner and lotilaner, the use of these isoxazoline drugs is not approved for use in livestock or food producing animals.

    If your companion dog or cat is not prone to fleas or you do not live in a tick-infested area, there is no reason to give flea and tick medications as preventatives. If these bugs attach themselves, you can use flea shampoos and combs, or specially designed tick removers. It is a little bit more work, but your companion pet’s health is worth it.

    W. Jean Dodds, DVM
    Hemopet / NutriScan
    11561 Salinaz Avenue
    Garden Grove, CA 92843

    References

    “Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products.” U.S. Food and Drug Administration, 20 Sept. 2018, http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm620934.htm.

    Dodds, Jean. “Heartworm: A Real and Present Danger.” Dr. Jean Dodds’ Pet Health Resource, 3 May 2015, Tumblr.

    Dodds, Jean. “MDR1 Gene Mutation in Dogs.” MDR1 Gene Mutation in Dogs, 26 May 2017, Tumblr.

    “Exzolt.” European Medicines Agency, 20 Oct. 2017, http://www.ema.europa.eu/medicines/veterinary/EPAR/exzolt.

    “MSD Animal Health Launches First Systemic Treatment for Poultry Red Mites; EXZOLT® Eliminates Infestations in European Poultry Houses.” Merck Animal Health, 5 Sept. 2017, http://www.merck-animal-health.com/news/2017-09-05.aspx.
     
  6. Tropicalbri's

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

    Both my pups developed head tremors after Simparico, Bravecto and Nexguard. We tried all three over a year period and the same thing happened. Now they only get the essential oils, water spray on them. With the Key Deer we get a lot of ticks down here but I have never had a problem with fleas or ticks on my two.
    Lots of fleas here too but my yard is treated naturally and so are the pups.
     
  7. strykerdobe

    strykerdobe Hot Topics Subscriber

    We do not use any Topical or Internal pesticides for Fleas or Ticks. Or even for Heartworm.
    We only use Essential oils and Wondercide.
     

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