FDA alert on tick/flea product

[DebraDownSouth]

This is not "we've found a new issue"... it's, we knew this, but we want the public to be aware:

https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm620934.htm

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.

[Dagodingo]

@debradownsouth It doesn’t affect my dogs as we use none of those products, but thank you for posting as I did not hear about this.

[DonC]

Another big thank you.

[Antigone]

I do not trust the FDA. That Agency is understaffed and the current Administration is anti-science. Merck is the best of the lot here but I never used their products for my Dogs and Cats. Thanks for posting.

[njdeb]

Thank you for posting this information which I'd not heard about. I don't use any of the products listed but will certainly pass it along to my barn buddies..... just in case!

[DebraDownSouth]

I always prefer topicals where possible, but many vets push pill form for flea/ticks. Then they don't warn them of signs of a serious reaction. While uncommon, people need to be aware.

[Antigone]

@debradownsouth The Small Animal Vets push whatever they are incentivized to push. My Mom worked for years at Ortho-McNeal and she knows how the drugs are tested all over the World but they only report the Data from the US. This is very dangerous and I am all for Homeopathic remedies such as Peppermint Oil for fleas and ticks. Essential Oils can be used for calming inflammation from an insect bite (Lavender Oil). I worked as a Vet Tech years ago and the Vet was really cheap. He actually charged $25.00 to put a sobbing Child's Hamster to sleep! The Vaccines are bought by the Lot and at the time the Vaccines cost .75 cents! Fort Dodge was the Supplier then and I do not recall who they merged with or were acquired by. That was the year they released the Feline Leukemia Vaccine. Last Month I lost one of my Christmas Eve Rescue Cats from NYC. He was a funny little Cat and I adored him. He had a Stroke and I had him Cremated because he was a special little guy. He was 14 years old. I still have the Female Cat and she too is 14. Sorry to get off topic but I do not trust Vets.

[DebraDownSouth]

I prefer products that actually work. You don't have to depend on just FDA, other countries report. Essential oils can be toxic, low effect if they work at all. But I use the min that I can on flea/tick products.

[Antigone]

@debradownsouth I subscribe to the American Veterinarians list and they are currently discussing the use of products such as Frontline and other flea and tick repellents. They are saying Frontline is not safe as lots os Dogs and Cats have died from it. Diatomaceous Earth (Human Grade) is made from ground up Crustaceans and it causes Spikes on the Coat of the Animal so when a Flea or Tick lands on your Pet it is shredded to death and falls off dead.

I have been using this since 1995 when I started Rescuing Horses because when a Fecal sample is taken there is not one parasite in the sample. It looks like Dirt and if you mix it with something your Pet considers a treat then they will eat it. I use Apple Sauce for the Horses, and Yogurt for the Dogs and Cats. I will find the link to the article and post it.

[DebraDownSouth]

@antigone said in FDA alert on tick/flea product:

I subscribe to the American Veterinarians list and they are currently discussing the use of products such as Frontline and other flea and tick repellents. They are saying Frontline is not safe as lots os Dogs and Cats have died from it. Diatomaceous Earth (Human Grade) is made from ground up Crustaceans and it causes Spikes on the Coat of the Animal so when a Flea or Tick lands on your Pet it is shredded to death and falls off dead.

Frontline has been around for at least 20 years. If you are on a "list" where folks chat, even non-vet folk like you, I don't much care what they chat about.

On their official pages, they do not say it is "not safe". Saying that there have been some deaths, generally from misuse, among many millions of applications isn't saying it is unsafe. People die from salt; children and adults have died from drinking too much water. Some babies are allergic to breast milk. Nothing on earth is 100 percent safe. The danger of fleas and tick diseases compared to the VERY high safety of Frontline should be considered. You don't like it? Don't use it. But please refrain from spreading garbage to mislead others.

The EPA has determined fipronil to be safe for use on dogs and cats, with no harm to humans who handle these animals. Poisoning cases from accidental use or misuse of fipronil may occur in animals....Most of the time poisoning cases of fipronil occur in dogs and cats due to accidental ingestion or licking the fipronil-containing product. Fipronil elicits neurotoxicity in mammals by inhibition of GABAA-gated chloride channels, producing hyperexcitability of the central nervous system. Overdosage due to accidental ingestion often leads to serious toxicosis. There is no specific antidote for the toxicity of fipronil. The manufacturer warns that the product may be harmful to debilitated, aged, pregnant or nursing animals and also states that fipronil must not be used on kittens less than 12 weeks of age and on puppies less than 10 weeks old.<<

AMVA says they rely on EPA reports, btw. EPA does not verify reports, they only collect them. The EPA knows, for example, that there were 270,000,000 (yeah 270 million) doses of spot on flea/tick products sold in 2007-2008, and that 43,000 reports of adverse reactions. That is 0.16 percent of the doses sold had an adverse effect reported. Even if miraculously they all really WERE related to the treatment, that's incredibly safe. Considering they say overdose and misuse main issue, for you to say they say it isn't safe is a gross misstatement of reality.

AMVA quote: EPA-registered products are generally very safe products to use, especially when they are used according to the manufacturer's label recommendations and when used by owners in consultation with their veterinarian. It is very important that pet owners consult with their veterinarian to determine which product may be the best choice based on the pet's health, age, and lifestyle.

On human grade Diatomateous earth, wrong again. It doesn't shed them to death, for crying out loud. It absorbs the freaking waxy/oily coat and the insect dies.

Food Grade and Non-Food Grade Varieties
Silica exists in two main forms, crystalline and amorphous (non-crystalline).

The sharp crystalline form looks like glass under a microscope. It has properties that make it desirable for numerous industrial applications.

The two main types of diatomaceous earth vary in their concentrations of crystalline silica:

Food Grade: This type contains 0.5–2% crystalline silica and is used as an insecticide as well as an anti-caking agent in the agricultural and food industries. It is approved for use by the EPA, USDA and FDA (3, 4).
Filter Grade: Also known as non-food grade, this type is said to contain upwards of 60% crystalline silica. It is toxic to mammals but has many industrial applications, including water filtration and the production of dynamite.
BOTTOM LINE:
Food grade diatomaceous earth is low in crystalline silica and considered safe for humans. The non-food grade type is high in crystalline silica and is toxic.
Diatomaceous Earth as an Insecticide
Food grade diatomaceous earth is often used as an insecticide.

When it comes in contact with an insect, the silica removes the waxy outer coating from the insect's exoskeleton.<<

While the DE may help cut the shell, it doesn't cut the pest up, it simply helps the drying agent go suck up all the moisture.

Inhaling it, like any dust particle, can be bad for your lungs, so don't do that.

[Antigone]

@debradownsouth I am on the list because the site allowed me to join by Identifying myself as a Vet Tech, which I was. I am just reporting what the Vets are saying about insecticides. Dogs and Cats can get Lymes Disease. Horses too can get it. In Horses it mimics EPM which is Horse Multiple Sclerosis.

I will find the link to the site tomorrow and post it. DE has always given my Horses a clean Fecal exam. There is not enough of the DE to be a hazard when mixing it with Applesauce. Generally, the Veterinary Community dislikes Homeopathic Modalities but more and more Homeopathic Vets are joining the American Homeopathic Veterinarian Association. These Vets have the same training other Vets because the Homeopathic aspect can only be achieved by becoming a traditional Veterinarian first.