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Bravecto - Cause for Concern?

17 CommentsSaturday, 21 January 2017  | 

Back in 2015 a widely-shared Facebook post claimed that Bravecto chewable flea and tick remedy is fatal to dogs. A family who had adopted a dog from Pet Helpers asserted that the dog had died as a result of being given Bravecto chewables and that another of their dogs had also nearly died.

vet listening to dog's heart

However, studies at the time suggested that Bravecto was safe. But that's not the end of the story. Following thousands of adverse reaction reports, Bravecto remains a potential cause for concern.

Let's start at the beginning.

As the warning spread on social media during 2015, it was picked up by the website Snopes, who attempt to confirm or quash various 'rumours'.

Investigating the claim, Snopes quoted a 2014 study published in the Parasites & Vectors journal where 32 beagles were treated with Bravecto (fluralaner) and no serious adverse side effects were attributed to the medication.

The full study can be found here https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3975339/

Snopes also cited the "Freedom of Information Summary" (pdf) 15th May 2014.

Finally, there was a post by Wilson Street Veterinary. Dr. Michael Mogavero stated that the drug had been extensively tested prior to its release and had proved safe for dogs https://www.facebook.com/photo.php?fbid=844030722346168

Snopes concluded that the Bravecto rumours were 'unproven'.

"The family of the depicted dog asserted that one of their pets had died within a day of being given Bravecto chewables and that another of their dogs had nearly died after being given the same treatment at the same time. The update also asserted that Bravecto chewables were responsible for the dog's death and that several other dogs had died of liver and kidney failure shortly after taking the same medication. (No information was provided showing or explaining a causal link between the dead dog and Bravecto chewables other than a post hoc ergo propter hoc assumption.)"

So who do we believe?

Of course, that Snopes article is dated now. Let's bear in mind that you can only write about what is known at that time. I can't help but wonder what their update might look like now, if they were to do one? Was that original anecdotal report by a dog owner only creating mass hysteria or worthy of proper consideration? If it was your dog and you strongly believed that a certain drug had harmed or even killed them, what would or should you do?

The evidence at that time seemed to suggest that Bravecto is safe. But that's not to say that, as with any drug, some dogs won't have a reaction. Also, with adverse reactions being reported, could real experiences from dog owners change this opinion?

The important thing to take from this is to always report any adverse reactions that you believe may be related to a drug taken by your dog. So let's take look at the ADE reports and then talk about how to report possible adverse reactions to drugs and medications.

The ADE database

The Center for Veterinary Medicine (CVM) maintains the CVM ADE database to monitor drugs after they have been approved. Any adverse effects not detected during pre-market testing can come to light. It is an official channel which can impact whether a drug stays on the market or not.

CVM's ADE reporting system depends on voluntary reporting of adverse clinical events by veterinarians and animal owners.

In November 2014 Elizabeth Carney, DVM investigated what, at the time, were two new FDA-approved products on the market that year for dogs - Nexgard (made by Merial) and Bravecto (made by Merck). To obtain more information about the safety of these two new drugs, Dr Carney submitted a Freedom of Information Act request to obtain the ADE reports.

November 2015 and the first set of reports were finally received. "Both reports contain information for the time period 1/1/2013 – 06/17/2015. For this time period, there were a total of 5,087 ADE reports received for afoxolaner (Nexgard) for dogs, and a total of 2,467 ADE reports received for fluralaner (Bravecto) for dogs."

In January 2016 Dr Carney posted an update with 06/18/15 - 01/06/16 data. For that time period there were 2,048 ADE reports for Nexgard and 2,852 ADE reports for Bravecto.

When comparing data, a great point to note was as follows: "Underreporting occurs with most adverse event reporting systems. The frequency of reporting for a given drug product varies over time, and may be greater when the drug is newly marketed, or when media publicity occurs."

Read Dr Carney's blog here, with links to the full ADE reports http://yourpetsneedthis.com/latest-greatest-flea-control-dogs/

An EMA (European Medicines Agency) 18 February 2016 public bulletin aimed at informing veterinarians and the public of the main outcome of post-marketing surveillance activities for veterinary medicinal products evaluated Bravecto as follows: "Monitoring is on-going since 2014 because of a relative high number of reports for this relatively new product."

EMA 18 February 2016 public bulletin - Bravecto

Reporting adverse reactions

If your dog has an adverse reaction to medications, vaccinations or microchips, did you know you can report it? Did you know that reporting it is actually quick and easy and can be done online?

It is important that we all report any adverse reactions, so there will be a record should it happen again to another pet.

To find out more, please visit Reporting Adverse Reactions.

Reporting adverse reactions to Bravecto

Bravecto flea and tick treatmentA Facebook group called Does Bravecto Kill Dogs? encourages dog owners to report any possible side effects their dog has experienced after taking Bravecto.

"It is very important that every adverse side effect be reported - even if it occurs once. You don't need proof of cause to report - only a suspicion that Bravecto caused the side effect. Take notes on any discussions you had including the names of the individuals you spoke with. This needs to be done if your dog is currently experiencing symptoms or had them in the past."

They explain that reporting reactions to Bravecto is a two step process.

1) Call Merck/MSD Animal Health. In some countries there is an option to email but calling is preferred. This link gives the phone numbers for MSD worldwide.

http://www.msd.com/contact/contacts.html

You should insist on getting a case number. If you can't get through to Merck/MSD, then proceed to step two.

2) File a report with the government agency responsible for oversight in your country. Click on this link for information on how to report in many countries:

https://www.facebook.com/groups/411371212394679/permalink/569469063251559/

Their page followers are also invited to share any adverse reactions they feel their dogs have suffered as a result of taking Bravecto. Of course, this should also be in addition to any official reporting of adverse reactions.

Update 22nd January 2017 - Thank you to a number of people who have commented here and on social media, giving me more information, which I have also included in this blog.

By Jenny Prevel

© D for Dog www.dfordog.co.uk
This article belongs strictly to D for Dog and we do not authorise the copying of all or any part of it.


M Caton
Saturday, 21 January 2017  |  21:05

Believe all the hundreds of people who have beloved pets have died in agony after taking Bravecto


Bridgit English
Saturday, 21 January 2017  |  21:35

Dogs with issues post Bravecto, vets and Merck appear to say it is a result of an existing underlying issue with the dog - -well if that's the case then can vets tell us what the dogs underlying issues are before Bravecto and therefore don't recommend Bravecto. You can't just after the event say oh it was underlying! Never used it and never will. Will investigate any drug before letting my animal ingest it now as a result of Bravecto.


Glynis Clayton
Sunday, 22 January 2017  |  0:12

In actual fact there has been no "long term" research into this drug. It is common practise for vet meds to be monitored within the community to establish long term effects. This is why it is so important to report. What concerns me is that Merck continue to tell people there have been no adverse reports when there have been thousands. Our dog had a severe grand mal seizure 5 days after being given Bravecto. I reported to Merck and was told it was the first they had received. I now know that this was untrue, thanks to the freedom of information act. Since then other owners of dogs having seizures have also been told it has not happened before in spite of receiving my report and others. My dog has fortunately been seizure free for 14 months. No more Bravecto for him.


D for Dog
Sunday, 22 January 2017  |  11:36

That is shocking. How can they get away with that?


Joann Perez
Sunday, 22 January 2017  |  2:40

It is not mass hysteria, these concerns about Bravecto. There are reports of deaths and serious side effects, both neurological and liver/spleen/kidneys. I have a senior dog who was given Bravecto when it was new on the market and she got seriously ill. The only factor that I believed caused this was her taking Bravecto. I called the Vet office (my Vet was in the process of retiring) and described her symptoms which were worse at night. She became withdrawn, her eyes would get very dialated and she would start trembling, shaking, panicking, jump on me and press into me across my face, very scared. This happened throughout the day and was worse at night. She had what appeared to be small seizures, wanted to hide in a closet, panicked and into the farthest corner. She was terrified and stayed that way for at least four months. The Vet office said it sounded like dementia. But my RN son and I were thinking side effect to Bravecto. I am glad I did not listen to my Vet office or I would have put her to sleep. Dementia is not reversible. Once her symptoms started to subside, it took months to get back to nearly normal. She is more aloof than before but pretty much recovered. The other two dogs took it too and had very minor listed side effects. So I gave them a second dose. Both had symptoms that were amplified but I cannot say what part Bravecto may have played because of their ages. One died within months after. She was very old. The other is terminal, but also very old. But my youngest dog's symptoms were not explainable from any other angle. No toxins other than the pesticides in Bravecto that she could have gotten into.


Eve
Sunday, 22 January 2017  |  4:57

This article is also reporting without the full and current information, as it is NOT looking at the more recent figures of pet deaths and illness as of 2017 and instead quotes information of the group from 2015, and also, sadly, Snopes (a rumour killing site) are only commenting on the specific case mentioned.

Yes, things are unproven. Yes, various vets agree and disagree.... but evidence is building (rest of sentence edited by admin).

Currently the big pharmaceutical companies making these treatments are even threatening legal action for people and Facebook groups saying bad things about their products (but you can say "I think" and "I believe that etc etc".

In much the same way as the big tobacco companies fought for years against statements or lawsuits that their tobacco products were harmful we are seeing the same thing now with the pesticide in question and similar named products and companies.

I personally know someone who lost one of her dogs who is convinced it was down to Bravecto.

Now, with regard the concern for the safety of these products, I believe it is justified and because of that concern would NOT recommend anyone use it for their pets until there is a greater oversight and review.

As for it not harming all pets, you have to realise that not all pets are the same! Some smaller breeds may be affected more then bigger ones, some specific breeds seem to have more reported cases regardless of size.

In the same way that not every human is affected by peanuts, peanut butter or shellfish... enough are to agree that the problem exists for some! I believe this is the case for these pet treatments, but simply put, enough pets are not affected by it (rest of sentence edited by admin).

However, if there were as many cases reported on death and serious medical injury in a human as has already been reported on these pet treatments you can be sure that the medicine would have been pulled further to a medical review on safety!

Some vets have even told distraught pet owners with their animals dead or dying in their arms that the treatment is harmless to the pet, that it doesn't affect their organs - yet a huge amount of cases have been autopsied and show massive damage and organ failure!?

Let me ask you some very important and relevant questions -

The treatment is designed to kill ticks and fleas, yes?

Ticks and fleas feed off of your pet's blood, yes?

So the chemicals that KILL the ticks and fleas MUST circulate in your pets body and bloodstream once ingested, yes?

So when the ticks and fleas suck the blood they, in turn, take in the chemical and it kills them, follow this so far?

Therefore, some of your pets may react more to this ingested chemical than others!

Your pet's internal kidneys and liver are designed by nature to filter toxins out of the digestive system and the blood (exactly where the Bravecto medicine puts it!!) and this may (edited by admin) have a correlation with the deaths and illnesses in pets with organ failure after taking these medicines.

Remember, if there were this many reported cases and deaths affecting humans the drugs would be pulled so fast your head would spin! (rest of paragraph edited by admin).

Are you willing to chance your pet's life without knowing more, or having more oversight and checks?

That's is all that is needed. Awareness and more testing, maybe they can tweak their product so they still make money but it is safer? In my opinion it needs to be safer and I wouldn't give it to my pets....

Because my pets are family!


D for Dog
Sunday, 22 January 2017  |  11:40

"This article is also reporting without the full and current information, as it is NOT looking at the more recent figures of pet deaths as of 2017".

Where would I find these figures please?


Jane
Sunday, 22 January 2017  |  17:21

If you mean the figures quoted on deaths etc. you have to apply to ASK EMA and they email the report in around a week.

BRAVECTO FIGURES ON EMA UP TO 23rd Nov. 2016.

Our most recent EMA figures are now 3332 adverse serious adverse events reported and 780 deaths as of 23rd. November. So reported ADE's are up 407 in the past month. 98 more reported deaths in last month.

We are waiting for a new report now.

The quickest reported death I read on the report was a 5 month old Shih Tzu puppy that died in vets office within 30 minutes of administering the tablet.


D for Dog
Monday, 23 January 2017  |  9:19

Thanks Jane.


Dr Ken Hines
Sunday, 22 January 2017  |  12:27

Very well written Eve, Well Done. At no point has it been claimed that Bravecto kills dogs, only some! nearly 800 at the last count. Your analogies with human medicine are very important.


Jane
Sunday, 22 January 2017  |  9:39

Several vets warning strongly against its use. Here is one of several issued by a vet. There are a few vets in the USA & AU, SA and the UK that will not use it so it is not 'unhinged pet owners' or 'hype'.

http://www.holisticandorganixpetshoppe.com/warning-bravecto-and-nexgard.html

"Bravecto has an active ingredient called Fluralaner. Due to the recent introduction, there is very little knowledge on tolerance in different dog breeds or in young, old or otherwise weak animals. Although there are reports of toxicity and death. Within 9 days of being given the product the dog developed anorexia, vomiting, and bloody diarrhea. This was followed by elevated calcium levels and multi-organ failure. Once you put them in you canít get them out. Most owners and veterinarians do not associate the side effects with the chemicals because the side effects may not show up for days to weeks after the drug is given. Many times the side effects do not show up until the second or third dose is given.
As Clayton Veterinary Associates put it: "Protect your pets and donít give in to the scare tactics of big pharma and the media."


D for Dog
Sunday, 22 January 2017  |  11:31

Thanks Jane, that's interesting.


Michele
Sunday, 22 January 2017  |  10:00

My dog is still receiving treatment and ultrasounds which is being paid for by the manufacturer. His liver and pacreas both affected by Bravecto, he has been so ill over the past eight months, which started the day after administering this product to him. Coincidence, or what?


D for Dog
Sunday, 22 January 2017  |  11:45

So this is interesting. If the drug manufacturer are paying for your dog's treatment, presumably they have admitted liability, in this case. What did they say Michele?


Jane
Tuesday, 24 January 2017  |  23:15

Re your question about update from EMA. They just had a meeting 17/19th January.
Bravecto mentioned again :-

"The Committee also reviewed the PSURs for Bravecto, Broadline and Osurnia and recommended amendments to their product literature. In addition, with regard to Bravecto the Committee requested a targeted PSUR on all serious adverse event reports."


http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fnews_and_events%2Fnews%2F2017%2F01%2Fnews_detail_002679.jsp&mid=WC0b01ac058004d5c1


Dawn
Thursday, 2 February 2017  |  23:26

Thank you so much for sharing this. I read your newsletter every month but something was telling me to read it today. I didn't have any idea about Bravecto. At last years vax appt., our vet suggested a new treatment that covered ticks. Our dog has never had ticks and gets on well with Advocate. I said no last year because I don't like testing new products on my dog. I did more research and learned about things like diameoteous earth and natural rememdies. We have continued with the Advocate this year but my husband said, why don't we try that new one and I said ok. We still had one Advocate left and even though the vet said to start the Bravecto, I thought, no, I feel a bit weird about it and just gave her a bath. I am so glad I have seen this because I would fall apart if I lost my dog. Going to steer well clear now. Thank you so much.


Billy Hargreaves
Friday, 3 February 2017  |  21:23

I am so glad to have read this tonight as I have this treatment ready to give to my dog which is overdue! I am not at home with my dog but will be calling my husband to throw it in the bin and ask the vet to supply Frontline again instead or look into a natural alternative. Anyone out there have any suggestions?

D for Dog
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