Fides

There is the feeling that Bravecto was rushed out to compete with Nexgard - they came out within months of each other. Nexgard applied their submissions for approval in US in September 2013, and in Europe Dec 2013, so coming up to two years now. The orals would give me more peace of mind knowing the tick is feeding its way to certain death once it bites, and avoid the problems that the topicals have e.g. swimming, or exposure to people, cats, dogs ingesting by licking etc. Hopefully with this being the first real tick season that both are available (and they must definitely be eating into Advantix sales with all the two-for-one offers Bayer has at the moment) there will be few reports here of adverse reactions and a clearer picture of its safety and efficacy can emerge. Mita that's very interesting and sounds like an effective way your vet recommends for dosing. They sit around in the tissue for weeks (or months in Bravecto's case) so you'd think splitting the dose like that would be a safer way to administer to avoid the immediate shock of a whacking great dose. Maybe in future, that will be a recommendation.

This is link to the FOI summary for the submission to FDA from May 2014 - hope the link works. http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM399075.pdf Sandgrubber - yes it definitely is complicated! Thanks for pointing out the control group in the reproductive study - I do usually mention the two litter losses in the control group (when I've mentioned the reproductive study in other places) but was just stating how 2 out of the 9 litters born had deformities. But only 20 Beagles (10 male, 10 female) were ever treated with Bravecto for the reproductive study and to me, that sounds like such a small number. I don't know how commonly deformities or litter losses occur in the general dog population, or if some breeds are more prone to problems, so it was the FDA's own conclusion that there are potential treatment related effects on pups that made me start wondering about the safety of the drug and Merck's claim for its use on breeding dogs. Also, my understanding of the eligibility criteria was the 4 pups per litter as you mentioned, but my interpretation was that there had to have been no congenital defects in any pup (not just from those litters). I could be wrong about that. Agree all these are pesticides which have side effects and the risk vs benefits must be weighed. People need to make their own decisions but be properly informed regarding this. I live in a tick prone area and tick paralysis is one of my biggest fears. I have picked a tick off my dog already this season (which has only just started in some parts of Australia). My dog is sensitive to permethrins like your dog, and it does limit my choices - it means Advantix, Kiltix, Scalibor and tick rinses are all out, and that pretty much only leaves Preventic, which has its own set of nasty adverse reactions, or the new orals. But given my dog has reacted to Advantix, I am just particularly wary of a drug taken internally which she might react to, that cannot be eliminated for three months and has no antidote. Even Nexgard, only on the market 2 years, is too new for me (especially considering they are a new class of pesticide not previously used even as crop pesticides) if there are other options which do work and she hasn't reacted adversely to. It's the chemical load on the organs in the new drugs that are the unknown - Bravecto sits in the liver, kidney, fat and muscle and who knows whether that will lead to renal/hepatic impairment with ongoing use, or how it might affect a dog that already has some degree of impairment? The studies just haven't been done, and there are no specific warnings on which dogs to take extra care with (apart from dogs with history of seizures I think, though that might be for Nexgard). Unlike US and Europe where it is prescription only, Bravecto is available over the counter here in Australia. Being a new and relatively unstudied drug, this really worries me - people can buy online win it at auction on eBay, or win in social media give-aways… and I think it can make people lose sight of the fact that it is a potent pesticide and there will be susceptible dogs out there. I'm sure in the majority of cases it's been taken with no ill effect. But one difficulty that people in that FB group have encountered is vets dismissing symptoms which the dog may experience after taking Bravecto and telling owners they are unrelated. Merck do mention the side effects that occurred in their studies, and there are dogs presenting with those side effects but are being told outright that it can't be from Bravecto. It's great your dogs have done well on Bravecto and I hope they continue to do so :)

No problem Lucky-Dog :) I just think it is too new and has not been studied well enough. It could be the majority of dogs tolerate it well and it works brilliantly, but there are others who've had ongoing severe side effects. And having said that, even if it's been taken without issue initially, I've read of cases where it the owner feels the dog is starting to experience side effects after the second or third dose. Bravecto was only released in Europe/US in April/May last year, so no dogs would have had that many doses yet if given every 12 weeks. My dog started developing reactions to Advantix. She was fine for about a year, but then would become very lethargic several hours after I applied it - she would not want to lift her head and just seemed disinterested. She'd always be back to normal the next day, but the last time I ever gave it, she started staggering around for a few hours before she settled. At that point I decided never again. So I'm wary of something taken orally if there is no antidote or way to clear it from their system. It would be wonderful to have something remove the worry of paralysis tick but Bravecto seems just as much a worry to me.

This is my first post though I have been a member of DOL for a few years and dog owner for most of my life. I guess it is my concern about Bravecto which has prompted me to finally post. Please do a lot of reading independently of what the drug companies say in regard to this drug. I have researched through Merck's submissions to FDA and EMA in Europe regarding the tests they have done. The reproductive study (on 10 breeding pairs of beagles only, where 2/9 litters produced deformities) left me reeling - the FDA's own conclusion is that there can be effects on pups related to treatment with Bravecto. "The repeated oral administration of fluralaner at a dose of up to 168 mg/kg was well tolerated in reproducing dogs. In adult dogs, potential treatment-related effects include seizures, diarrhea and salivation after dosing. In puppies, potential treatment–related effects include limb deformity, enlarged heart and spleen, and cleft palate." In the US, Bravecto requires a prescription from the vet, so it is not over the counter like here. And one of the reasons for this apart from FDA wanting better reporting of adverse events, is it requires professional expertise to consider the suitability of Bravecto for breeding dogs i.e. weighing the risks v benefits. The product information leaflet in the US also states the findings of the reproductive studies but not the conclusions (pups born with cleft palate, limb deformities etc)… Also, with the margin of safety tests (i.e. overdose studies) were conducted on 32 Beagles, beginning when they were aged 8-9 weeks. The test lasted 24 weeks, then pups were euthanised. Nothing is known about the long term or cumulative effects. Young dogs may well metabolise it differently to older dogs, dogs with intercurrent medical problems or on medications. The literature about fluralaner (i.e. Bravecto) is that it is rapidly absorbed, then stored in fat, muscle, liver and kidney for 12 weeks, 90% is excreted unchanged in the faeces. Who knows really what happens as the pups tested above did not have their urine or faeces, or organs studied for any accumulation. Regarding splitting or crushing - please don't do this! See the FDA's handling procedures just to reinforce that it should be handled as a poison... "The product labeling contains the following information regarding safety to humans handling, administering, or exposed to BRAVECTO: Not for human use. Keep this and all drugs out of the reach of children. 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. Wash hands thoroughly with soap and water immediately after use of the product." I'm part of a group on FB that is looking into its safety and raising awareness of side effects and the proper channels to report adverse events. If you want to learn more, please look it up : Does Bravecto Kill Dogs. It was started by a lady in the US whose 1.5 year old Cavalier died in August, just weeks after taking Bravecto (a necropsy was performed). Her beautiful dog suffered terribly. It is not a scare mongering group even though I admit the name of the group might make you think it only wants you to draw that conclusion. There are vets that belong to this group and there is a lot of information there such as the documents I've quoted above, and others like MSDS. I haven't used it and don't know anyone who has, so I can't say how effectively it works and whether there are side effects that I know of personally. However, in the FB group, there are alarming similarities (of some very severe side effects in which some dogs have died) being reported independently from people around the world.