Dutch Government: Bravecto not withdrawn from market
In the Netherlands, the undersecretary of economy mr Van Dam has no intentions whatsoever to get the anti-flee pills from Bravecto out of the vet’s shops. That was his statement in response to questions mrs Esther Ouwehand of the Party for the Animals asked.
The questions were asked because of the recent commotion on both social media and television about Bravecto. Van Dam stated that “at the moment we cannot find enough evidence for a relation between possible side-effects and the use of the pills.”
As this is written at least 50 times possible side-effects were reported. The complaints vary from nausea to diarrhea, neurological problems and even diseased dogs. In the Netherlands since registration in 2014 over 750,000 doses were sold, worldwide even up to 34 million doses. Therefore I will await the periodical safety reports and the judgement by EMA”, Van Dam said.
Whether or not action might be taken in a later stage Van Dam prefers to remain silent about until the reports of EMA (European Medicines Agency) have arrived. As soon as irregularities are found that have a connection with the use of this drug EMA will advise the European Committee which further steps should be taken. Those steps may vary from adjustment of the leaflet to suspending or withdrawing the marketing authorization. The final decision about this authorization is made by the European Committee.
“When necessary I can make prescribing by vets and use prohibited. But as stated I will await the final safety reports by EMA”, Van Dam said.
Van Dam does acknowledge the fact that until now EMA received over 3,000 reports. He also said that PSUR, the Periodic Safety Update Report in which worldwide side-effects are mentioned and that was published late October, will be treated with priority by EMA. Earlier evaluations never gave reasons to change the licence, Van Dam stated.
Earlier Dogzine asked the manufacturers Merck Sharpe and Dome Animal Health for a reaction. The manufacturer said that “many of our own people at MSD Animal Health are animal owners themselves and we love our animals. Nothing is more important to us that the safety and reliability of our products to provide health and wellbeing of our animals. We have confidence in the safety of both Bravecto and Nobivac L4. Both products were administered to billions of dogs all over the world. The registration authorities in these countries confirm both products are safe to use in the way the labels explain. The safety of pills and vaccines are vastly tested in research.”
The news of some weeks ago about a dog that the owner said died after the use of Bravecto is doubted by MSD. “We take all reports on side-effects very seriously and research things very carefully. Where possible we cooperate with the pet owner and the vet to get as many clinical facts as possible in order to help and find the cause of the health problem. In this specific case it was never confirmed the dog recently was given Bravecto, according to the patients’ file of the own vet it was never given. It is important to check every report very carefully on medical facts versus anecdotes that aren’t based on scientific of medical evidence. A posting on social media doesn’t mean there is a connection to this specific drug. Vets are in the best position to advise owners about the correct treatment and we advise pet owners to discuss what is best for the animal with vets.” MSD said.