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.
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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.
