My HPRA: Register

Safety of flea and tick tablets in dogs

Notice type: Advisory

Date: 21/08/2017

  

Product name or type:
Flea and tick tablets

Prescription Required:
Yes

Target Audience:
​Veterinary practitioners, pharmacists, dog owners

Problem Or Issue:
New warnings for centrally-authorised oral dog flea and tick product, Bravecto.

Background Information Or Related Documents:

Bravecto Tablets were authorised by the European Commission on 11 February 2014, following the opinion of the Committee for Medical Products for Veterinary Use (CVMP) at the European Medicines Agency (EMA). Following a routine review of the worldwide adverse event experience with Bravecto tablets, the CVMP confirmed that the product continues to have a favourable benefit/risk profile but decided at their July 2017 meeting to request the marketing authorisation holder to update the product literature as follows:

  • Use with caution in dogs with pre-existing epilepsy
  • Convulsions and lethargy have been reported very rarely in spontaneous (pharmacovigilance) reports

   

The term ‘very rare’ is defined as reported in less than 1 animal in 10,000 animals. The product package leaflet is being updated accordingly but it is expected that it will take a number of months to be implemented.

The EMA has recently published a ’news item’ in relation to this matter.

Note that the new warnings apply only to the tablet formulation of Bravecto.



    Actions To Be Taken:
    • Veterinary Practitioners should inform owners of the possible side effects when prescribing Bravecto tablets for dogs
    • Owners should always follow the directions for use for all veterinary medicines, unless specifically directed otherwise by their veterinary practitioner
    • Where an adverse event following use of a veterinary medicine is suspected, it should be reported to your veterinary practitioner, who should, in turn, should report it to the HPRA
    • If in doubt about the use of Bravecto for your dog, discuss it with your veterinary practitioner


    Further Information:
    The HPRA and the EMA respectively authorise veterinary medicines for national and European wide use. Veterinary medicines are authorised only following a detailed examination of their quality, safety and efficacy, provided the benefits outweigh any expected risks. Once authorised, veterinary medicines are monitored and any suspected adverse events must be reported to the national competent authority (the HPRA is the national authority in Ireland) or to the marketing authorisation holder (which will then notify the authority involved).

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