Other safety alerts
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| European Union: Tick and flea control agent Bravecto continues to be acceptably safe to use. New adverse reaction to be included in package leaflet. |
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The European Medicines Agency (EMA) concluded in July 2017 that Bravecto, a medicine that treats tick and flea infestations in dogs and cats, continues to have an acceptable safety profile. However, the company that markets the product will have to update the package leaflet and include convulsions as a new side effect that is reported very rarely, i.e., less than one animal out of 10,000 animals treated. Veterinarians and pet owners will also be advised to use Bravecto with caution in dogs with epilepsy.
EMA’s Committee for Medicinal Products for Veterinary Use (CVMP), following a regular but inconclusive analysis of limited data on serious side effects, had requested the company to investigate all relevant reports related to various disorders such as neurological, skin and appendage diseases, hypersensitivity or immune-mediated reactions and liver diseases, some of which were fatal. The investigation had to take into account the age and breed of animals, the number of treatments, underlying disease conditions and concomitant treatments. According to the company, about 41.6 million doses had been distributed worldwide, of which approximately 18 million were in the European Union (EU) between February 2014 and December 2016. By 15 August 2017, suspected side effects had been reported electronically for 5,326 dogs, of which 2,144 were in the EU. Between February 2014 and 15 August 2017, deaths had been reported in 1,265 dogs worldwide and 342 in the EU. Each report relates to dogs under different health conditions, often receiving multiple medicines, therefore these figures may or may not be related to the use of Bravecto in dogs.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002798.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 5 Bravecto (fluralaner) products, including Bravecto Chewable Tablets For Very Small Dogs 112.5mg (Vet) (HK-65276), Bravecto Chewable Tablets For Small Dogs 250mg (Vet) (HK-65277), Bravecto Chewable Tablets For Very Large Dogs 1400mg (Vet) (HK-65278), Bravecto Chewable Tablets For Large Dogs 1000mg (Vet) (HK-65279) and Bravecto Chewable Tablets For Medium-sized Dogs 500mg (Vet) (HK-65280). All products are registered by Merck Sharp & Dohme (Asia) Ltd, and are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to Bravecto (fluralaner). Letters to inform the Hong Kong Veterinary Association of the above safety information will be issued and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Aug 18, 2017
Issued at HKT 17:00
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