[Jane L]

It’s a shame isn’t it Becca that we can’t all have a sensible discussion without a certain person, that said they were butting out two days ago, reappears with more misinformation!

It makes no odds to me what product any of you use on your dogs as long as you way up the risks and are prepared for the consequences if your dog is one of the unlucky ones.

If anybody wants any advice ask. I have test results, studies etc. and all FDA & EMA ADE reports. A lot of links are being removed as part of their famous ‘transparency’ now they won their court case preventing the EMA sharing testing reports. It seems they might have something worth hiding!

And re their last retort it has been flagged and is under review and I already shared the link showing this. The announcement was made on the EMA meeting on 17/19th January 2017.

[Jane L]

Have you read an ADE reports on the huge number of dead and stillborn puppies?

Even in testing there was a high % of deformities especially cleft palet and limb deformities. Breeders from many Countries are reporting fertility issues as well as dead a deformed puppies. Litters of up to 10 are dying within days of suckling or stillborn.

• This reply was modified 7 years ago by Jane L.
• This reply was modified 7 years ago by Jane L.

[Jane L]

I thought you said you were shutting up at least ten comments ago?

I reply to other people that ask questions not trolls but one thing I will say to you is yet again you are talking total rubbish. The Bravecto group never ever said it does not kill ticks. It’s a very efficient killer. It’s the fact that a tick takes up to 12 hours to die that is the issue and that because of this many dogs still get tick diseases.

I wish if you bother to comment you would get your facts straight as Merck confirm this and it’s listed in data sheet under the cons.

PARASITIPEDIA

“Detailed information on the toxicity and the fate of fluralaner in the dog’s body (absorption, distribution, metabolism, excretion) and in the environment is scarce.

Due to their recent introduction there is very little knowledge on tolerance in different dog breeds or in young, old or otherwise weak animals.

There is so far little information available on this active ingredient. It is similar to Afoxolaner, another active ingredient introduced by MERIAL (NEXGARD) recently approved in the US and the EU.

“Fluralaner is available for oral administration to dogs, i.e. it has a systemic mode of action. Ingested fluralaner is rapidly absorbed into blood and distributed throughout the whole body of the treated dog. Blood-sucking parasites (mainly fleas and ticks) are killed during their blood meal.

But the systemic mode of action means also that for fleas and/or ticks to be killed, they have to bite the dog first and suck enough blood before the ingested active ingredient kills them. Whether killing is fast enough to prevent disease transmission is not yet known.”

• This reply was modified 7 years ago by Jane L.
• This reply was modified 7 years ago by Jane L.

[Jane L]

http://yourpetsneedthis.com/zoetis-simparica-bravecto-nexgard/

This has interesting information. Including this.

FURTHER INVESTIGATION NEEDED!!

I am astounded to read the final paragraph under Animal Safety on the product insert. I’ve included it word-for-word below. For me, these are simply the most intriguing four sentences I have read ALL YEAR.

Why?

Because I believe whatever happened in this dog is the VERY process that is occurring in all of the dogs who’ve experienced side effects with Bravecto and Nexgard. Some of these dogs have died. We must determine what is happening here!

“In a separate exploratory pharmacokinetic study, one female dog dosed at 12 mg/kg (3X the maximum recommended dose) exhibited lethargy, anorexia, and multiple neurological signs including ataxia, tremors, disorientation, hypersalivation, diminished proprioception, and absent menace, approximately 2 days after a third monthly dose. The dog was not treated, and was ultimately euthanized. The first two doses resulted in plasma concentrations that were consistent with those of the other dogs in the treatment group. Starting at 7 hours after the third dose, there was a rapid 2.5 fold increase in plasma concentrations within 41 hours, resulting in a Cmax more than 7-fold higher than the mean Cmax at the maximum recommended use dose. No cause for the sudden increase in sarolaner plasma concentrations was identified.“

[Jane L]

Same class of new drugs in the class of Isoxylines as is the latest Simparica.

The reviews in Australia are awful. It does come with seizure warning as does Simparica. Merck have still not added one to the oral yet in spite of them saying that the ingredient Fluralaner can cause seizures on the new topical versions. On the two most recent FDA reports seizures were almost double with Nexgard than Bravecto.

http://www.productreview.com.au/p/nexgard-chewables.html

[Jane L]

Totally wrong. They lived longer. Yes less vaccines which is good as after puppy shots they don’t need them from core diseases.

All dogs I ever had from 1950’s on lived 12/15 years. I knew many people with up to 18 dogs each back in the 1980’s and not one ever had allergies. And there is a massive difference between allergies and Demodex.

Now every day on my group dogs have allergies usually triggered by vaccines especially L4 but that’s another issue!

[Jane L]

If it prevented tick disease but it doesn’t. Hundreds of cases of tick diseases as dogs must be bitten.

[Jane L]

You must be joking. 20 years ago was not the dark ages and we went to the vet in the 60’s to 90’s and would know if a dog had cancer. Dogs also did not all have allergies then as so many do now.

Cancer is caused by the carcinogens in kibble, imported Chinese treats, over vaccination and toxic flea and tick products.

[Jane L]

Very true. One article I read recently said a few years ago cancer was not even in the top ten causes of death in dogs and now it’s the number 1 cause with up to 3 in 5 dogs getting cancer.

Some talk as if there are no other options. It’s only been on the market three years, amazing how we survived up until then isn’t it 😫

[Jane L]

I don’t have a way if addressed to me. Never find a need to use any chemical flea or wormer but if I did Bravecto, Nexgard & Trifexis would be the last on my list and I would prefer a flea infestation to feeding neurotoxins to any dog of mine.

[Jane L]

There are some 🙂

http://www.petmd.com/dog/parasites/4-surprising-flea-diseases-you-need-know

Highly unlikely though I would imagine but just saying before Cameron does 🙂

[Jane L]

interesting article on Lyme’s disease here.

Also with Bravecto, Nexgard etc. that have no deterrent be aware hundreds of reports are inefficiently as the dogs still get tick disease as disease can pass much faster than the 12 hours each tick can feed before it has ingested enough of your dogs poisoned blood!

http://www.dogsnaturallymagazine.com/the-surprising-cause-of-lyme-disease-in-dogs/

[Jane L]

Well that is a wager you would loose as I have no idea who Judy or Mary are.

I only warn of the risk as I have had hundreds of very distraught owners wishing they had been warned.

If you want to use it do so but there is no reason for your very rude posts. I for one am not a liar. When I say I know many vets that warn against it, refuse to sell ever or have now stopped selling it that is a fact.

And on what do I use the answer is nothing for the majority of the year and a light spitz of natural spread very occasionally but I am not in a tropical climate.

The majority of people could manage with natural if they were prepared to put in some effort. If you go with the easy route you risk problems with any insecticides especially oral.

[Jane L]

Yes as Susan says the EMA is the European Medicines Agency. They did not do any studies the testing was all done by Merck / MSD with no independent studies. The EMA is where all serious reported adverse reactions and deaths Worldwide are meant to be forwarded within 15 days of the report.

http://www.ema.europa.eu/docs/en_GB/document_library/Newsletter/2017/02/WC500222245.pdf

on page 4 it says:-

‘The MAH was asked to provide a targeted PSUR that should include an
extensive analysis and review of all serious reaction reports with neurological
disorders, skin and appendages disorders, hypersensitivity/immune mediated
reactions and hepatopathy, also with death and death by euthanasia. This
targeted PSUR will be assessed by the CVMP and depending on the outcome
additionally measures will be taken.
In addition, during the last period of surveillance “
lethargy” has been identified and the MAH was requested to update the SPC to include this term in the SPC.’

Anybody can also apply for an ADE report and read the cases which read like these 3 x examples :-

Suspected Adverse Reaction:-
On 5 Feb 2015, a veterinarian reported that a dog had a seizure and weakness approximately 6 hours after receiving half a tablet of Bravecto 1400 mg (over 88 lbs. and up to 123 lbs.) (Extra Label Use-Treatment Program Not Respected) on 3 Feb 2015. The dog had another seizure on 4 Feb 2015. The signs resolved on 5 Feb 2015. Four other dogs were given the product and none of them had a reaction. Follow-up information is pending. Follow-up on 27 Feb 2015 via email: the owner, who is also the vet, reports that the dog had Bravecto on 2 Feb 2015 (previously reported as 3 Feb 2015). Updated patient information was reported (11 yr old female rottie cross). Besides the 2 seizures, which were previously reported, the vet also mentioned that the dog’s legs were very weakened to the point where she could not get up or lie down. Bloodwork, including a 4DX snap test, were negative and skull radiographs were clear. She was circling and head pressing and could only eat if hand fed as standing was very difficult for her. She remained weak and was euthanized on 25 Feb 2015.

***
Suspected Adverse Reaction: On 11 Dec 2015, a veterinary technician reported that a 5-month-old, 2-kilogram dog was taken to the veterinary clinic for grooming on 10 Dec 2015. Before bathing, the dog received a 112.5 mg Bravecto chew. While drying (approximately 30 minutes after Bravecto administration), the dog had a seizure and died. Petechial lesions on the abdomen had also developed. A necropsy had not been performed at the time of the report. Follow-up information is expected. Follow-up on 12 Jan 2016: A necropsy report was received. Gross pathological findings included multifocal petechial hemorrhages of the mucosa/serosa in multiple organ systems, moderate congestion in the coronary and myocardial vessels, and severe congestion of the meninges, which were adhered to the cranium. The presumptive diagnosis was hepatic encephalopathy. Hepatic findings were compatible with hepatic glycogenolysis or glucocorticoid hepatopathy, which is consistent with differentials such as hyperadrenocorticism, severe stress, or an iatrogenic origin (e.g. glucocorticoid administration). The microcirculatory lesions are associated with microcirculatory collapse, shock, and death, which suggests a possible hypersensitivity reaction to products administered to this patient.

*****

Suspected Adverse Reaction: Bravecto 250mg was administered to adog on 13 Nov 2015. One hour later the dog’s skin was red and after that, the dog had seizures. The owner brought the dog to the clinic, but it was dead on arrival, approximately 1.5 hours after administration.

*****

You are all free to use what you wish so if you think the convenience of feeding this insecticide once every 3 months to your dog is worth the risk go right ahead but at least you have read the warnings and know the risk. There are many settlements too if waivers are signed.

[Jane L]

You are wasting your breath obviously once Cameron referee to Snopes 😜 That is quite funny for some talking science!

For anyone interested Snopes have not updated their unproven statement from June 2015 on Duncan’s death in spite of being provided with his MSD cases number, letters to owner from Merck and paid vet bills on the owners surviving dog. This case was the first to hit the news and another 4000 odd cases / 900 approx. deaths have followed on. If these reported cases are just 1% as they say is the norm then obviously this is a massive issue. I think with groups now in so many Countries anybody with half a brain can see there is a big problem here. So be aware if you dog reacts there is no antidote and so far there are no clues why some are react so violently and others days after dose 3 or more and others appear fit after over two years. If you love your dog why take the risk especially as it does not even prevent tick disease and works by your dogs blood feeding parasites? Surely a deterrent to prevent the bite is preferable?

Unproven does not mean it did not happen it means there is not 100% proof of the cause. It’s the 100% conclusive scientific proof that appears impossible but if you feed you dog one of these so called ‘tasty treats’ and within minutes on many occasions it starts seizing I think you know the cause. The intelligence of someone referring to Snopes as the fountain of all knowledge is laughable 🙄😫

Anybody interested in reading facts just apply to the EMA and read the cases and see how they singled it out at the January meeting for targeted PSUR’s.

[Jane L]

A Biologist will be interested to know her views are not science!

One more. An conventional as well as holistic.

http://www.drjudymorgan.com/chemicals-kill/

[Jane L]

For anybody interested not Cameron who I am not responding to. Here are two articles written by vets and one by a biologist.

As I say I know many vets that warn against and will not sell in many Countries. I have read reports and viewed many necropsies. Yes no conclusive proof as that seems impossible but the EMA review cases and hundreds are listed as probable cause.

So just go on the risk / reward and decide if you think it’s a risk worth taking.

http://vitalanimal.com/bravecto/

http://www.dogsnaturallymagazine.com/bravecto-nexgard-simparica-oral-flea-tick-preventives-safe/

http://www.isbravectosafe.com/bravecto-files/501-IS-BRAVECTO-SAFE-ABOUT-BRAVECTO-AND-FLURALANER-THE-WAY-THE-MEDICATION-WORKS.pdf

And here

“All 4 Paws Veterinary Hospital
3 February ·
And this, dear clients, is why we do NOT carry trifexis, comfortis, and bravecto, or simparica or vectra or any other topicals especially hard on cats.
We carry only heartgard or sentinel and nexgard for heartworm, fleas and ticks in dogs
And we recommend Revolution in cats.
Capstar is amazing at helping with severe infestations and is extremely safe.
That’s it.
There’s a large class action lawsuit with trifexis and comfortis also.
We support the products made and extensively safety tested , and safe since 8 weeks old
Bravecto and others are NOT approved until 6 months of age.
When we read the safety literature, we realized we were uncomfortable with the safety data.
Please tell your friends and help people keep their pets safe.
Always remember to buy these products from your veterinarian, not because of the money, but because merial backs its products 100% for a refund or treatment, if there should be any bad side effects.
If you buy them from some diverted pharmacy or 1800petneds, you have zero recourse for treatment costs etc.
That is so important.
Most vets will pricematch anyway.
We do, as we prefer you get a fresh and real , well stored product.”

https://www.facebook.com/All4Pawsvet/

[Jane L]

Oh I can assure you I am fully aware of the Vioxx case and full rap sheet. Yes sadly it took over 60k human deaths in the 4 years they dragged their feet before Vioxx was withdrawn.

Do you know this part?

http://www.cbsnews.com/news/merck-created-hit-list-to-destroy-neutralize-or-discredit-dissenting-doctors/

I actually know many vets. Some warn strongly against its use. Some have seen what it has done to clients dogs. It’s still a mystery what exactly is going on. Many deaths are days after dose three. Some cases the dogs react in minutes. Some still appear to be ok after over two years.

• This reply was modified 7 years ago by Jane L.
• This reply was modified 7 years ago by Jane L.

[Jane L]

Yes that’s Sweden. Not been there that long. If really interested just get a report which I have. Many cases are listed as probable cause or known reaction. Many cases are vets own dogs. Some happened in vets offices. One 5 month old puppy dead in 30 minutes.

On my latest report dated 7/03/2017 from the EMA (European Medicines Agency) there are now 3988 reports / 972 deaths.

This is up from January 9th when there was 3,668 reported serious adverse events including 874 deaths. So an increase of 320 reports / 98 deaths in the two month period.
1647 reports /486 deaths are in the USA.

If you are happy to risk it that’s you choice. I hope for you dogs sake you don’t regret as so many do.

I hope the June announcement is that it is withdrawn. At least the dog topical has not arrived still so maybe the fact that the human adverse reactions jumped from 33 to 74 in just a few weeks on the arrival of the cat spot on and they were unable to prevent cross contamination even in the laboratories maybe that is shelved.

• This reply was modified 7 years ago by Jane L.

[Jane L]

Yes “straying in deep weeds” might be risky. Pick up a tick and you might need to trial the Bravecto instead giving it to your poor dog 🙄

[Jane L]

How many would you like. Here is the EMA announcement of targeted PSUR’s. Some decision in June is mentioned.

Official German statement and one from Sweden. There are also publications news reports from Netherlands, Beguim. Poland and more. You can find them all online including the 30 minute documentary from Holland.

http://www.atl.nu/lantbruk/fastingmedel-granskas-efter-larm/

http://www.bvl.bund.de/DE/05_Tierarzneimittel/05_Fachmeldungen/2017/2017_01_24_Fa_Bravecto.html

The MAH was asked to provide a targeted PSUR that should include an extensive analysis and review of all serious reaction reports with neurological disorders, skin and appendages disorders, hypersensitivity/immune mediated reactions and hepatopathy, also with death and death by euthanasia. This targeted PSUR will be assessed by the CVMP and depending on the outcome additional measures will be taken.
In addition, during the last period of surveillance “lethargy” has been identified and the MAH was requested to update the SPC to include this term in the SPC.

http://www.ema.europa.eu/…/Newslett…/2017/02/WC500222245.pdf

Articles from Sweden, Poland, Russia, here is one if you want to translate.

http://www.ed.nl/binnenland/onderzoek-naar-dodelijk-middel-tegen-vlooien-bij-honden~a7592e05/

[Jane L]

US Adopted Name “fluralaner” is: 4-[5-(3,5-Dichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-m- ethyl-N-[(2,2,2-trifluoro-ethylcarbamoyl)-methyl]-benzamide (CAS RN [864731-61-3]).

The liver produces and secretes bile into the intestine where the bile assists with the absorption and digestion of dietary fat. The liver aids purification of the blood, by altering potentially harmful chemicals into harmless ones, and then: either secretes them with the bile for elimination in the stool, or back into the blood, where they then are removed by the kidneys and eliminated in the urine. The typical non-specific symptoms of degenerative liver disease (loss of appetite, nausea/vomiting, lethargy, etc.) are common first “symptoms” of “adverse reaction” to Bravecto®.

The dog’s pancreas (endocrine and digestive system) produces insulin hormones (regulates the flow of glucose/sugar) and enzymes that break down fat and proteins to aid in the digestion of foods. When overburdened, the pancreas becomes inflamed, and the flow of enzymes into the digestive tract is disrupted; the enzymes may be forced out of the pancreas and into the abdominal area. These digestive enzymes will begin to break down fat and proteins in other organs… (the body begins to digest itself). Because of their proximity, the kidneys and liver are prime targets of this progression.

Enterohepatic Circulation that leads to hepatic toxicity/

And as a side note would it be under investigation by the EMA as well as Sweden, Germany, Netherlands if there were not serious concerns?

[Jane L]

If that was true would the ADE reports on the liver failure deaths be assessed as probable and possible cause and would their letters to owner of one dead dog describe it as an idiosyncratic responce to the ingredient? The necropsy finding even pointed to two previous assaults on the liver could tie in with the dogs first two doses where she had just been sick for a day or two. It was dose three that caused almost immediate serious reaction and death only days later which has happened many times.

[Jane L]

Be very careful as they state the ingredient can cause seven in animals with no history or seizures. This is on the new topical and not added to oral still in spite of hundreds of seizures reported. In Australia a veterinary nurse said they are told it must not be sold to dogs with seizure history. I have seen many videos of seizures though, some starting within minutes of them taking it and not always after the first dose. Several have ended up having to be euthanised. Some are offered settlements on signing waivers.

IMPORTANT SAFETY INFORMATION (CATS):
The most common adverse reactions recorded in clinical trials were vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy, and scabs/ulcerated lesions. 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 American dog ticks beyond 8 weeks of dosing. For topical use only. Avoid oral ingestion. The safety of Bravecto has not been established in breeding, pregnant and lactating cats.
Use with caution in cats with a history of neurologic abnormalities. Neurologic abnormalities have been reported in cats receiving Bravecto, even in cats without a history of neurologic abnormalities.

IMPORTANT SAFETY INFORMATION (DOGS):
The most common adverse reactions recorded in clinical trials were vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist dermatitis/rash. Bravecto has not been shown to be effective for 12-weeks’ duration in puppies less than 6 months of age. Bravecto is not effective against lone star ticks beyond 8 weeks of dosing. For topical use only. Avoid oral ingestion.
Use with caution in dogs with a history of seizures. Seizures have been reported in dogs receiving fluralaner, even in dogs without a history of seizures.

[Jane L]

This is clearly explained in Dogs Monthly magazine April issue. Part explained the numerous seizures which are a listed possible reaction to the ingredient Fluralaner on the new topical though not added to the oral stil.

Regarding liver and kidneys it says :-

“Fluralaner will in fact pass through both the liver and the kidneys but is not metabolised by either and is excreted in the faeces in the same form. I concede that the drug is not metabolised by the liver and kidneys but this does not mean that the organs are not affected. The liver will try very hard to break down the foreign substance or toxin and in doing so damages its performance. The enzymes levels rise dramatically as it attempts unsuccessfully to destroy fluralaner. It would seem, as resilient as a liver can be, there are examples of the liver failing. Similarly with the kidneys, They do not metabolise fluralaner but this does not mean the kidneys do not try to rid the body of the nasty toxin which kills insects. As a result the kidneys are in some cases severely damaged and can fail. Some of the other symptoms reported could be because the drug is circulating in the body round and round trying to find a way out. Pancreatic metabolism could be affected as well. It is reported that the drug is only excreted in the stools. In order to get there, once absorbed into the blood stream, it can only go via the liver and the biliary system, so it’s not surprising it takes a long time to be eliminated.”

Also in this article it says the main route of elimination is likely to be hepatic.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4886404/

“For fluralaner, the main route of elimination is likely hepatic because the high plasma protein binding [4] indicates minimal elimination via renal filtration. Plasma clearance can therefore be assumed to be equivalent to hepatic clearance. The clearance of fluralaner is low with only 0.14 L/kg/day in dogs [4] and 0.23 L/kg/day in cats. Considering a physiological hepatic blood flow of approximately 44.5 L/kg/day in the dog or 38.6 L/kg/day in the cat [15] and assuming hepatic clearance of fluralaner of 0.14 L/kg/day and 0.23 L/kg/day, respectively, the hepatic extraction ratio for fluralaner is estimated to be low (0.3 % in dogs [4] and 0.2 % in cats). The low clearance may be due to the high protein binding of fluralaner, which limits the unbound fraction of fluralaner in the vascular system that can be presented to clearing organs and/or due to a low intrinsic hepatic capacity to metabolize fluralaner [16–18].”

[Author]

Posts