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Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products
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.
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.
Atrium Flea and Tick Guidelines and Recommendations: Flea and tick document
Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA
For Immediate Release
July 19, 2018
Canine Epilepsy Resource Center: http://www.canine-epilepsy.com/
Canine Influenza- June 12, 2017
In the wake of the recent outbreak of canine influenza in the Southeast, we want to educate our clients on the facts of canine influenza and preventative measures we recommend at this time.
Those at highest risk of exposure are dogs who frequent dog parks, doggy day cares, and/or other dog social facilities. At this time, we recommend dogs avoid these venues to limit potential exposure.
We have Jade Screen Eight, an anti-virus herbal, which can be used for prevention or for symptomatic dogs. There is also a vaccination for this virus and we do have the vaccine in stock. Initial vaccines will need a booster 2-4 weeks after the initial vaccination. Ask your veterinarian which approach would be best for your dog.
Please read the following information about CIV and call us if you have any additional questions.
Atrium Animal Hospital
Canine Influenza Virus
- Canine Influenza Virus is spread through:
- Close proximity to infected dogs (it is airborne and can travel up to 20 ft.; Dog parks are ideal for spreading the virus)
- Contact with contaminated items (bowls, leashes, crates, tables, clothing, dog runs, etc.)
- People moving between infected and uninfected dogs
- 80% of all dogs that are exposed to the virus will contract it
- The virus lives up to 24 hours on soft surfaces and up to 48 hours on hard surfaces.
- Some exposed dogs will be subclinical carriers – meaning some dogs will contract and spread the virus without showing symptoms.
- Dogs show clinical signs within 24-48 hours and can shed the virus for up to 28 days from exposure.
- Most dogs will completely recover with proper treatment.
- Dogs that regularly interact with dogs outside of their own family or frequent places where many dogs gather are most susceptible to exposure to Canine Influenza Virus.
- Dry, hacking cough (similar to kennel cough)
- Lack of appetite
- Discharge from the nose or eyes
- Fever (normal temperature is 101 – 102)
- The best protection is vaccination. There is now a single vaccination for both the H3N2 and H3N8 strains of the virus. The vaccination requires a booster shot two weeks after the initial vaccine. Vaccination provides the best chance of immunity within 7-14 days of booster shot.
- Isolate sick animals and keep them isolated for up to 30 days after symptoms subside.
- Practice good sanitation. Use a bleach and water mixture diluted to 1-part bleach x 30 parts water to disinfect common areas such as tables, bowls, leashes, crates, etc. Allow items to thoroughly air dry for a minimum of 10 minutes before exposing dogs to them. Bleach breaks down quickly so solution should be made daily. Keep in mind that bleach becomes inactive in UV light. If mopping use two buckets so as not to cross contaminate areas
- Wash your hands frequently, ideally between handling different dogs. At the very minimum, hand sanitizer should be used between handling dogs.
- Use disposable gowns or wipe down clothing and shoes with a bleach solution between dogs or after leaving an area where dogs congregate.
- Food/water bowls should be made of stainless steel instead of plastic because scratched plastic is hard to fully disinfect.
- Treatment of Canine Influenza Virus requires veterinary assistance. If you believe your dog may have Canine Influenza Virus, please contact your veterinarian immediately. Untreated, the illness may progress to pneumonia or other, more serious problems. H3N2 can lead to severe secondary pneumonia which can cause extremely sick dogs with potential fatalities.
- Most dogs take 2-3 weeks to recover from the illness.
- Any dog suspected of having Canine Influenza Virus should be immediately isolated from other dogs and should not attend dog shows, day care, grooming facilities, dog parks, or other places dogs gather. Dogs are contagious for up to 30 days once they have started showing symptoms.
- Contact your veterinarian to let them know that your dog may be showing symptoms of Canine Influenza Virus. If your dog is going to a veterinary hospital or clinic, call ahead to let them know you have a suspected case of Canine Influenza Virus. They may ask you to follow a specific protocol before entering the clinic to minimize the spread of the disease, including waiting in your car until they are ready to examine your dog.
- Keep sick dogs at home and isolated from other dogs and cats until you are certain the illness has run its course (typically 3-4 weeks).
Consideration for Event Venues
- Use a bleach and water mixture diluted to 1-part bleach x 30 parts water to disinfect common areas including show floors, grooming tables, ring gates, in-ring examination tables and ramps, and x-pens. Allow solution to completely dry (at least ten minutes in order to assure virus has been killed). Bleach breaks down quickly so solution should be made daily. Keep in mind that bleach becomes inactive in UV light. If mopping use two buckets so as not to cross contaminate areas.
- When wiping down hard surfaces paper towels are preferred over cloth.
- Consider having two exam tables at every ring so that they can be cleaned and allowed to air dry frequently in between classes.
- Provide hand sanitizer in each ring and in grooming areas.
- Exhibitors should consider grooming dogs at their cars instead of using grooming areas where dogs are in very close proximity.
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