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Safety in use of veterinary medicinal products for animal euthanasia

Notice type: Advisory

Date: 28/02/2017

 The HPRA has become aware of a number of adverse event reports in other EU member states relating to lack of expected efficacy of veterinary medicinal products (VMPs) indicated for euthanasia in large animals, due to failure to fully comply with recommendations for use of the products as detailed in the summary of product characteristics (SPC). 

Product name or type:
Products indicated for euthanasia in animals

Active Substance:
Pentobarbital sodium, sodium pentobarbital, secobarbital sodium & cinchocaine hydrochloride

Product Classification:
Neurological preparations

Target Audience:
Veterinary practitioners

Problem Or Issue:

While there have been very few reports of lack of expected efficacy relating to VMPs for euthanasia in Ireland, in view of the reports observed in other EU member states and the implications for the safety of the person administering the product and animal welfare, the HPRA considers it prudent to remind veterinary practitioners of the importance of following exactly the recommendations for use as detailed in the package leaflet and summary of product characteristics (SPCs) for this class of product. In particular veterinarians are requested to be mindful of the following when using such products:

  • Dosage: Note any weight limits listed or recommendations for species subsets e.g. heavy animals.
  • Route(s) of administration: Pay particular attention to routes requiring pre-medication or use of an intravenous catheter in large animals. Note any specific instructions regarding speed of injection.
  • Measures post-administration: Note any specific instructions regarding checking for vital signs. It is always advisable to have an alternative method of euthanasia available.
  • Storage conditions: Note any storage restrictions relating to temperature, light, shelf life following withdrawal of first dose etc. These are particularly relevant for large animal practice where products will be transported and stored in vehicles.
  • Environmental conditions: Note advice relating to environmental surroundings of animals, handling of animals etc.
  • Disposal of animal carcases: Care should be taken to ensure that other animals cannot access the carcases of animals euthanised with such products due to the risk of secondary intoxication following ingestion. Incineration is recommended where possible.

Background Information Or Related Documents:

In 2016 there were 101 adverse event reports submitted to the European Union’s Central Database relating to adverse reactions or lack of expected efficacy following use of veterinary medicinal products indicated for euthanasia in animals. None of the reports originated from Ireland. Of the 101 reports, 82 related to products that are authorised in Ireland.

A number of different species were involved in the 82 reports including; dogs: 28 reports, horses: 22 reports, cats: 18 reports, cattle: 4 reports, rabbits: 4 reports, sheep: 2 reports, guinea pig: 1 report and rat: 1 report. The species was unspecified in two of the reports. Fifty five of the reports related to adverse reactions and 27 of the reports related to lack of expected efficacy. Clinical signs listed in the adverse reaction reports included ataxia, prostration, somnolence, coma and in some cases death in dogs that ingested remains of other animals euthanised with the products concerned. Other signs in animals administered the products concerned included vocalisation, injection site pain and convulsion. Twelve of the reports involved confirmed off-label use of the product and additionally it was unknown whether the product was administered as recommended in a number of other reports. 

Actions To Be Taken:

Veterinarians are requested to thoroughly familiarise themselves with all sections of the SPCs for euthanasia products prior to use. SPCs for all authorised VMPs are available on the HPRA website.

Any adverse events following use of VMPs should be promptly reported to the HPRA via the online reporting form https://www.hpra.ie/homepage/about-us/report-an-issue/veterinary-medicines-adverse-reaction or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity. 

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