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New adverse reaction to be included in package leaflet

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.

The company that markets the medicine is expected to implement the changes to the package leaflet within six months of the CVMP conclusion.

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.

In case of side effects experienced by their pets, owners or carers should seek advice from the veterinarian responsible for their animals. Veterinarians and healthcare professionals are advised to report any potential adverse reactions following the use of Bravecto to the regulatory authority in their country or to the company, which is obliged under EU legislation to forward this information to the relevant regulatory authority.

The CVMP will continue to look into all side effects reported as part of its routine safety monitoring process of veterinary medicines.

Notes

• Bravecto was authorised in the EU on 11 February 2014. It is available as chewable tablets for dogs and a spot-on solution for cats and dogs. It can also be used as part of a treatment strategy for the control of flea allergy dermatitis.
• Reports of both serious and non-serious adverse events are regularly reviewed by EMA as part of the continuous benefit-risk assessment of veterinary medicines. EMA’s CVMP currently reviews periodic safety update reports (PSURs) for Bravecto submitted by the company every six months.