Bravecto: Reported Side Effects Pet Parents Should Know About

Flea and Tick Products: Reported Side Effects Pet Parents Should Know About

Seizures continue to be an issue with a certain class of flea and tick products. Fox 59 reports the latest case out of New Jersey.

«In November, a veterinarian recommended that Tugba Aksoy have her dog Lokum switch from his flea and tick collar to Simparica, a newer class of prescription-only flea and tick medications.»

Lokum ended up having a seizure. The owner rushed him to the emergency room at an animal hospital, where a veterinarian told her Lokum’s seizure was likely caused by the new medication.

Simparica, Nexgard, Bravecto and Credelio are all drugs in the isoxazoline class.

The agency called for new labeling:

«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. Revolution Plus, which was approved most recently, includes the new labeling information to highlight the potential for neurologic events in the isoxazoline class, and Merial has made the requested changes to Nexgard’s labeling including adding the new class statement.»

Original post published in February 2019.

Does Bravecto kill our dogs? According to Bravecto’s site, their chew and topical solution kills ticks and prevents flea infestations for 12 weeks. Specifically targeting the black-legged tick, American dog tick, brown dog tick, and the the lone star tick this drug also is said to have «some» side effects including vomiting.

But what is extremely concerning about this drug is the number of deaths and the following reported by the site, Is Bravecto Safe?

As of August 2018,

«The European Medicines Agency (EMA) reports that there were 8,692 adverse reactions after the administration of Bravecto. And there were 2,056 reported deaths.»

There is even a Facebook group full of concerned pet parents that literally focuses on this topic alone with heartbreaking stories.

A post shared by Kat Brinksma (@katbrinksma) on Dec 19, 2016 at 8:49pm PST

In September 2018, the FDA issued a warning about Bravecto and other flea and tick products.

Dr. Jean Dodds tells us,

«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.»

Symptoms and Side Effects of the Toxicity

A post shared by Darcy (@darcythecavoodle) on Dec 20, 2016 at 3:25am PST

Vertigo, seizures and neurological symptoms are reported as the main signs of toxicity.

Dog owners report side effects including excessive thirst, dehydration, nausea, panting and pink colored skin. There’s also the MDR1 mutation which 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.

The MDR1 gene mutation undergoes one or more mutations that allow a higher absorption of drugs and toxic substances to enter the central nervous system and then they can breach the blood-brain barrier and create adverse reactions. This is very serious when you’re considering flea and tick medication for these breeds.

With all this mind, the common adverse reactions reported in customer reviews clearly show that Bravecto chews are not worth the risk. So what happens if your pet does have an adverse reaction? Whatever the active ingredient is in the tick control medication could have been the issue.

A story reported by NBCnews.com,

«If your pet experiences a bad reaction from a spot-on product, immediately bathe the pet with mild soap, rinse with large amounts of water, and call your veterinarian,» the FDA advises.

Remember to always talk to your veterinarian before applying any spot-on products, especially if your dog or cat is very young, old, pregnant, nursing, or on any medications. The Bravecto topical solution for dogs and cats is included in the report mentioned in this story.

If your dog has a history of seizures or you have a lactating dog, you should talk with your vet about the proper medication that kills ticks effectively. One common issue for pet parents is when a dog or cat doesn’t like chewable tablets so thoughts on how to give them a single dose is important! Other important factors like body weight and months of age will be considered by your vet. Talk to your vet about an alternative option called Comfortis, this spinosad controls tick infestations.

www.wideopenpets.com

Bravecto (fluralaner topical solution) for Cats

Bravecto (fluralaner topical solution) for Cats

(fluralaner topical solution) for Cats

Bravecto (fluralaner topical solution) for Cats Caution

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Each tube is formulated to provide a minimum dose of 18.2 mg/lb (40 mg/kg) body weight. Each milliliter contains 280 mg of fluralaner.

The chemical name of fluralaner is (±) — 4 — [5 — (3,5 — dichlorophenyl) — 5 — (trifluoromethyl) — 4,5 — dihydroisoxazol — 3 — yl] — 2 — methyl — N — [2 — oxo — 2 — (2,2,2 — trifluoroethylamino) ethyl]benzamide. Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone

Bravecto (fluralaner topical solution) for Cats Indications

Bravecto kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater.

See also:  CDC - Scabies

Bravecto is also indicated for the treatment and control of Dermacentor variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater.

Dosage and Administration

Bravecto should be administered topically as a single dose every 12 weeks according to the Dosage Schedule below to provide a minimum dose of 18.2 mg/lb (40 mg/kg) body weight.

Bravecto may be administered every 8 weeks in case of potential exposure to Dermacentor variabilis ticks (see Effectiveness).

Body Weight Ranges (lb)

Fluralaner content (mg/tube)

* Cats over 27.5 lb should be administered the appropriate combination of tubes.

Step 1: Immediately before use, open the pouch and remove the tube. Hold the tube at the crimped end with the cap in an upright position (tip up). The cap should be rotated clockwise or counter clockwise one full turn. The cap is designed to stay on the tube for dosing and should not be removed. The tube is open and ready for application when a breaking of the seal is felt.

Step 2: The cat should be standing or lying with its back horizontal during application. Part the fur at the administration site. Place the tube tip vertically against the skin at the base of the skull of the cat.

Step 3: Squeeze the tube and gently apply the entire contents of Bravecto directly to the skin at the base of the skull of the cat. Avoid applying an excessive amount of solution that could cause some of the solution to run and drip off of the cat. If a second spot is needed to avoid run off, then apply the second spot slightly behind the first spot.

Treatment with Bravecto may begin at any time of the year and can continue year round without interruption.

Contraindications

There are no known contraindications for the use of the product.

Not for human use. Keep this and all drugs out of the reach of children.

Do not contact or allow children to contact the application site until dry.

Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. Do not eat, drink or smoke while handling the product. Avoid contact with skin and eyes. If contact with eyes occurs, then flush eyes slowly and gently with water. Wash hands and contacted skin thoroughly with soap and water immediately after use of the product.

The product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.

Precautions

For topical use only. Avoid oral ingestion. (see Animal Safety).

Fluralaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders.

Bravecto has not been shown to be effective for 12-weeks duration in kittens less than 6 months of age. Bravecto is not effective against Dermacentor variabilis ticks beyond 8 weeks after dosing (see Effectiveness).

The safety of Bravecto has not been established in breeding, pregnant and lactating cats.

The effectiveness of Bravecto after bathing or water immersion has not been evaluated.

Adverse Reactions

In a well-controlled U.S. field study, which included a total of 161 households and 311 treated cats (224 with fluralaner and 87 with a topical active control), there were no serious adverse reactions.

Percentage of Cats with Adverse Reactions (AR) in the Field Study

Adverse Reaction (AR)

Bravecto Group: Percent of Cats with the AR During the 105-Day Study

Control Group: Percent of Cats with the AR During the 84-Day Study

In the field study, two cats treated with fluralaner topical solution experienced ataxia. One cat became ataxic with a right head tilt 34 days after the first dose. The cat improved within one week of starting antibiotics. The ataxia and right head tilt, along with lateral recumbency, reoccurred 82 days after administration of the first dose. The cat recovered with antibiotics and was redosed with fluralaner topical solution 92 days after administration of the first dose, with no further abnormalities during the study. A second cat became ataxic 15 days after receiving its first dose and recovered the next day. The cat was redosed with fluralaner topical solution 82 days after administration of the first dose, with no further abnormalities during the study.

In a European field study, two cats from the same household experienced tremors, lethargy, and anorexia within one day of administration. The signs resolved in both cats within 48-72 hours.

In a European field study, there were three reports of facial dermatitis in humans after close contact with the application site which occurred within 4 days of application.

For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact Merck Animal Health at 1-800-224-5318. Additional information can be found at www.bravecto.com.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Clinical Pharmacology

Peak fluralaner concentrations are achieved between 7 and 21 days following topical administration and the elimination half-life ranges between 11 and 13 days.

Fluralaner is for systemic use and belongs to the class of isoxazoline-substituted benzamide derivatives. Fluralaner is an inhibitor of the arthropod nervous system. The mode of action of fluralaner is the antagonism of the ligand-gated chloride channels (gamma-aminobutyric acid (GABA)-receptor and glutamate-receptor).

Effectiveness

In a well-controlled European laboratory study, Bravecto killed 100% of fleas 8 hours after treatment and reduced the number of live fleas on cats by > 98% within 12 hours after treatment or post-infestation for 12 weeks. In well-controlled laboratory studies, Bravecto demonstrated > 94% effectiveness against Ixodes scapularis 48 hours post-infestation for 12 weeks. Bravecto demonstrated > 98% effectiveness against Dermacentor variabilis 48 hours post-infestation for 8 weeks, but failed to demonstrate ≥ 90% effectiveness beyond 8 weeks.

See also:  Bug, Definition of Bug at

In a well-controlled U.S. field study, a single dose of Bravecto reduced fleas by ≥99% for 12 weeks. Cats with signs of flea allergy dermatitis showed improvement in erythema, alopecia, papules, scales, crusts, and excoriation as a direct result of eliminating flea infestations.

Margin of Safety Study: In a margin of safety study, Bravecto was administered topically to 11- to 13-week (mean age 12 weeks)-old-kittens at 1, 3, and 5X the maximum labeled dose of 93 mg/kg at three, 8-week intervals (8 cats per group). The cats in the control group (0X) were treated with mineral oil.

There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, clinical pathology (hematology, clinical chemistries, coagulation tests, and urinalysis), gross pathology, histopathology, or organ weights. Cosmetic changes at the application site included matting/clumping/spiking of hair, wetness, or a greasy appearance.

Oral Safety Study: In a safety study, one dose of Bravecto topical solution was administered orally to 6- to 7-month-old-kittens at 1X the maximum labeled dose of 93 mg/kg. The kittens in the control group (0X) were administered saline orally.

There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, clinical pathology (hematology, clinical chemistries, coagulation tests, and urinalysis), gross pathology, histopathology, or organ weights. All treated kittens experienced salivation and four of six experienced coughing immediately after administration. One treated kitten experienced vomiting 2 hours after administration.

In a well-controlled field study Bravecto was used concurrently with other medications, such as vaccines, anthelmintics, antibiotics, steroids and sedatives. No adverse reactions were observed from the concurrent use of Bravecto with other medications.

Do not store above 86°F (30°C). Store in the original package in order to protect from moisture. The pouch should only be opened immediately prior to use.

How Supplied

Bravecto is available in three strengths for use in cats (112.5, 250, and 500 mg fluralaner per tube). Each tube is packaged individually in a pouch. Product may be supplied in 1 or 2 tubes per carton.

Approved by FDA under NADA # 141-459

Distributed by: Intervet Inc (d/b/a Merck Animal Health), Madison, NJ 07940

Fluralaner (active ingred.) Made in Japan.

Formulated in USA

Copyright © 2016, 2019 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved

179726 R3 021378

Customer Service: 800-521-5767
Order Desk: 800-648-2118
Technical Service (Companion Animal): 800-224-5318
Technical Service (Livestock): 800-211-3573
Fax: 973-937-5557
Website: www.merck-animal-health-usa.com
Every effort has been made to ensure the accuracy of the Bravecto (fluralaner topical solution) for Cats information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2020 Animalytix LLC. Updated: 2020-04-01

www.drugs.com

Bravecto for Dogs: Paws Up or Down?

Every dog owner knows that fleas and ticks are bad news for a beloved pet. Without regular protection, your dog can quickly become infested with these pests that can bite and transmit diseases to your dog and your family.

A flea infestation on your dog can quickly become a big problem for your home environment. Fast breeding and difficult to stamp out, the key to ensuring your home doesn’t become a haven for fleas is to not allow them to live on your dog.

Bravecto for dogs is a chewable tablet that delivers 12 weeks of flea and tick protection. In this review of Bravecto for dogs, I will go over how the product works, side effects, safety concerns, where to buy it, and whether or not I give this product “Paws Up or Down.”

Contents & Quick Navigation

Bravecto Rating

Bravecto for Dogs

Bravecto is a unique product in flea and tick protection because its chemical makeup kills active infestations and prevents future infestations.

Bravecto contains fluralaner, an active ingredient that kills adult and juvenile fleas as well as a variety of ticks including the black-legged, brown dog, American dog, and Lone Star. Unlike Bravecto, most flea and tick medications only work to stop the reproduction of fleas and ticks rather than to kill fleas and ticks already on the dog.

Bravecto is a prescription medication so in order to get it, you must have approval from your vet. Many veterinarians recommend and prescribe Bravecto for one simple reason: it works.

When I started looking into the reviews for Bravecto for dogs, a common thread among pet owners is how easy the product is to administer; as a chewable tablet, dogs readily gobble it down.

The chewable is so much better than a topical product. I have used the so-called “spot on” products in the past and it was always a mess and has an unpleasant smell!

If I can manage to get my dog to stay still for long enough to squirt all of the treatment onto the right spot between the shoulder blades, invariably she shakes right after and sends the liquid running down the ridge of her back. Naturally, she follows that up laying on her back in her bed or on the carpet, wiggling around to scratch the offending tickle and the treatment gets rubbed off.

I also wonder how effective the product will be when she has wiped so much of it off. Worse still, I have young kids in the house and I don’t want them touching her and getting the treatment on their hands or bodies.

Many of the reviews for Bravecto flea and tick protection also highlight the convenience of the dosing which lasts 12 full weeks. Having to provide a dose every 3 months instead of every single month is very nice and can save you money, too.

Bravecto can be used in dogs as young as 6 months old weighing at least 4.4 pounds and is considered safe for pregnant, breeding, and lactating dogs. Speak to your vet about a flea and tick solution that would work best for your smaller or younger pup.

See also:  PHE publishes new tick leaflets to remind people to be tick aware

Like all flea and tick medications, Bravecto is prescribed to your dog in the appropriate strength based on your dog’s weight. The heavier your dog, the higher the concentration of the active ingredient present in the drug.

Bravecto and corresponding concentrations of Fluralaner are broken down in the following dosage categories:

  • Toy Dog formulation for dogs weighing 4.4-9.9 pounds contains 112.5 mg of Fluralaner
  • Small Dog formulation for dogs weighing 9.9-22 pounds contains 250 mg of Fluralaner
  • Medium Dog formulation for dogs weighing 22-44 pounds contains 500 mg of Fluralaner
  • Large Dog formulation for dogs weighing 44-88 pounds contains 1000 mg of Fluralaner
  • Extra Large Dog formulation for dogs weighing 88-123 pounds contains 1400 mg of Fluralaner
Product Name Price on Chewy.com Description
Bravecto Chews for Dogs, 4.4-9.9 lbs, 1 treatment $52.49 Toy Dog formulation for dogs weighing 4.4-9.9 pounds contains 112.5 mg of Fluralaner
Bravecto Chews for Dogs, 9.9-22 lbs, 1 treatment $52.49 Small Dog formulation for dogs weighing 9.9-22 pounds contains 250 mg of Fluralaner
Bravecto Chews for Dogs, 22-44 lbs, 1 treatment $52.49 Medium Dog formulation for dogs weighing 22-44 pounds contains 500 mg of Fluralaner
Bravecto Chews for Dogs, 44-88 lbs, 1 treatment $52.49 Large Dog formulation for dogs weighing 44-88 pounds contains 1000 mg of Fluralaner
Bravecto Chews for Dogs, 88-123 lbs, 1 treatment $52.49 Extra Large Dog formulation for dogs weighing 88-123 pounds contains 1400 mg of Fluralaner

If you miss a dose of Bravecto all you have to do is give the chew to your dog right away. Mark your calendar for the next dose to be given 12 weeks later rather than sticking to the old schedule.

When checking out Bravecto flea and tick reviews I noticed that many dog owners began using this product after a yard or pet infestation was in full swing. When your dog is being attacked by fleas or ticks in large numbers, it is miserable for every member of the family and you want relief, fast.

Bravecto kills greater than 98% of active fleas, both adolescent and adult, on your dog within 12 hours. It kills 100% of ticks on your dog within 12 hours.

We all know that flea bites itch and can make sensitive dogs break out in rashes and hot spots and that both fleas and ticks carry some really nasty diseases that you all want to avoid. Bravecto reviews state that the product starts working really fast, helping to get an infestation under control quickly.

For a period of 12 full weeks after treatment with Bravecto, you can expect your dog to have a 98.8% reduction in fleas. Those are some seriously impressive results and a big relief to an infested dog and her family.

It’s important to note that in the case of yard or home infestation, you will have to seek the assistance of a pest control company to get rid of the problem. If you only treat your pet, your house and yard can remain infested which is a health concern to you and your family.

Is Bravecto Safe?

Bravecto is considered safe for most dogs. Vets everywhere recommend this flea and tick solution because it is safe, effective, and easy to use.

Bravecto has been approved by the Food and Drug Administration (FDA). This means that the drug has been tested and that the benefits of the medication outweigh the risks in taking it.

A field study was also conducted on 294 dogs to determine if Bravecto is safe. In that study, the most common side effect experienced was vomiting and no serious adverse reactions were reported.

Given that some dogs have experienced seizures as a side effect with Bravecto, it is very important that you tell your vet if your dog has any history of seizures. With a history of seizures, it would be best to use a different flea and tick solution.

There are not any known adverse interactions between Bravecto and other drugs. Nonetheless, it is always best to tell your vet of all current medications your dog is taking before starting a new one.

Bravecto Side Effects

As with nearly any medication, there is a risk of some side effects. Bravecto has been studied extensively to receive FDA approval but the following side effects have been reported with the use of Bravecto:

  • Flatulence
  • Vomiting
  • Diarrhea
  • Increased thirst
  • Decreased appetite
  • Lethargy/weakness
  • Seizures

Obviously, seizures are serious and the risk of this side effect cannot be overlooked. If your dog experiences seizures after taking Bravecto, take them to the vet immediately.

The other side effects are unpleasant but certainly not life- threatening. If your dog has any of these milder side effects after taking Bravecto, talk to your vet and get a recommendation.

Where Can I Get Bravecto?

You must have a valid prescription from your dog’s vet to buy Bravecto. This flea and tick medicine can be purchased directly through your vet or through a specialty pet retailer like Chewy.com.

In some Bravecto reviews, consumers mention that this medicine is priced higher than its competitors. Bravecto only has to be applied every 12 weeks, not every month, so over time it can actually cost less, especially if you take advantage of sales and discounts with online retailers.

Bravecto for Dogs: Paws Up or Down?

I gave Bravecto 4 stars and a big “paws up!” The product is FDA approved, very effective, fast-acting, and easy to administer, but it has a higher initial price tag than competitors.

www.labradortraininghq.com

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