Bravecto® may cause convulsions in dogs on rare occasions

10 August 2017

The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.

The analysis was made by the manufacturer Intervet International B.V. at the request of the Committee for Medicinal Products for Veterinary Use (CVMP) under the European Medicines Agency (EMA). CVMP has reviewed the report from Intervet International B.V. and agrees with the main conclusions.

Bravecto® contains the active substance fluralaner, which paralyses the nervous system of fleas and ticks. The nervous system in fleas and ticks is many times more sensitive than in mammals, and the product is generally safe.

However, the new analysis of the reported adverse events shows that Bravecto® may cause convulsions and fatigue on very rare occasions. The product should be used with caution especially in dogs with pre-existing epilepsy.

As part of the safety monitoring of medicinal products, companies and authorities receive reports of suspected adverse reactions. The reports are used to assess the frequency of adverse reactions and whether a certain adverse reaction occurs more frequently for a particular medicinal product. If the risk of an adverse reaction is ”very rare”, it means that the adverse reaction occurs in less than one in 10,000 users.

Following the review, the summary of product characteristics of Bravecto® will be updated to include a warning about the risk of convulsions and a new special precaution for use in dogs with pre-existing epilepsy.

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