Tick & Flea Med WARNING!

[Olesia711]

From USA FDA - 9/20/2018
https://www.fda.gov/AnimalVeterinary/Ne ... 620934.htm

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.
Additional Information

Fact Sheet for Pet Owners and Veterinarians about Potential Adverse Events Associated with Isoxazoline Flea and Tick Products
Contact FDA
240-402-7002
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7500 Standish Place, HFV-1
Rockville, MD 20855


From Dr. Jean Dodds blog today:

https://drjeandoddspethealthresource.tu ... 7uUmvZReM9

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/New ... 620934.htm.

Dodds, Jean. “Heartworm: A Real and Present Danger.” Dr. Jean Dodds’ Pet Health Resource, 3 May 2015, http://www.drjeandoddspethealthresource ... 7OlAWhKjIV.

Dodds, Jean. “MDR1 Gene Mutation in Dogs.” MDR1 Gene Mutation in Dogs, 26 May 2017, http://www.drjeandoddspethealthresource ... 7OmzWhKjIV.

“Exzolt.” European Medicines Agency, 20 Oct. 2017, http://www.ema.europa.eu/medicines/vete ... PAR/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.

[Madelon]

WOW! Thanks Olesia for this important information. I know one of our members lost his non-EPI dog after giving Nexguard - it's so sad. I personally use Frontline - a lot of vets, including my own, say it doesn't work well anymore but we are not a high risk and so far so good for us at least.

[Olesia711]

I thought this was especially important to share with our group because EPI dogs immune system often appears to be compromised..... so ... IMHO..... better to be extra cautious than sorry.....

[Patsy]

Very useful info for epi dogs etc.
We had a flea problem last year, and frontline was useless, confirmed by my vet. After a thorough examination he prescribed Simparica for my healthy tiny fluffy dog. I was very nervous, but all was ok. It is a monthly tablet, unlike Bravecto which stays in the system for three months, strong stuff. It certainly worked, and I haven’t used it since. The small print advised only using it for a year, without a check up. That said it all to me.
Thanks for the details.

[jilbert57]

Thank you for the information. I had been using Nexguard for a couple years but no more. I almost ordered Credelio, but thought why not to back to Frontline Plus(we have alot of ticks due to amount of wildlife going through the yard)Maybe it will work once again.

[Olesia711]

i learned my lesson after my EPI gal Izzy developed IMHA.... a very serious condition that has a 50-80% mortality rate..... i had to be careful of so many chemicals, prescription or otherwise! My gal cannot even take Heartworm meds nor can she receive any vaccines, and is legally excused from state required rabies shots...this kind of explains how serious the wrong chemical can be for her, i even have to watch what cleaning products i use in the house and we cannot use any bug sprays outside either. After doing my research, i learned that the only tick and flea med that i could use on an IMHA patient was Frontline Plus ....BUT... i could only give it once every 45 days. I had to be very, very careful not to overload with the chemicals, even acceptable ones.

Where i lived at the time was "tick-heaven" ... vets had signs up everywhere to give tick and flea med every 3 weeks (1 week ahead of the recommended monthly dose) ... i was concerned that it just wasn't going to work out. Well, surprise, surprise... giving Frontline (the one that supposedly doesn't work well anymore) AND giving it only once every 45 days, not 30 days, not 24 day... It worked ! Over the past 5 years, i have since switched all my dogs back to Frontline Plus and i only give it once every 45 days. No ticks, no fleas.

I am not saying this is going to work for everyone... but for us, it worked

[Ruby]

Fantastic information, Olesia. I wish I could condense some of it and share on my facebook or through e-mail. I remember you told me not to use Bravetco on Ruby. I thank you for that, since she is very sensitive to meds. If I use anything at all I have used just Advantage. But, only if really, really needed. Since she had lost soooo much hair I could pick fleas off her with a flea comb that has worked well also. Thanks again for the great info. you have shared.

[Olesia711]

Hi Marilyn,

In short..... my take away from my personal experience is to not "over-load" any dog with too many chemicals of any kind.... even with the healthy dogs.

[jilbert57]

I am trying a top spot called Activyl. So far so good it has been a week. I will try the Frontline Plus again because with the elk, coyotes, racoons, bobcats, etc... we have ticks too.

[Barb]

Thanks for this, Olesia. We have weaned Kolby off of all meds for flea and ticks(we still give Heartworm) and are using just a comb. I am amazed that it is still working, especially in this area where we live, but this is the fourth year without meds. However, he did just recently develop two "hot spots".....I took him in to be checked and they do not appear to be flea related. We are treating with Dermachlor Rinse.....chlorhexidine gluconate...... to see if we can avoid antibiotics. So far so good.

Never a dull moment.

Thank you for the information about the troubling brands.

Barb