The pharmacovigilance team at the Veterinary Medicines Directorate (VMD) monitors adverse event reports for veterinary medicines authorised in the UK. We receive adverse event reports from vets, animal owners and Marketing Authorisation Holders (MAH).
We have received lack of efficacy reports concerning the use of the euthanasia product - Somulose Solution for Injection (secobarbital and cinchocaine). We would therefore like to remind vets about the information contained in the Summary of Product Characteristics (SPC) to make sure they are administering Somulose correctly. The SPC is on the VMD’s Product information database.
Somulose is authorised for euthanasia in dogs, cats, horses and cattle. Lack of efficacy of a euthanasia product, particularly in large animals, can have significant safety implications for the person administering it. It also has welfare implications for the animal and clearly may be emotionally distressing for owners.
Our review of adverse event reports for this product indicates that the majority of suspected lack of efficacy reports received are for horses. We thought it might be beneficial to highlight the information in the Summary of Product Characteristics (SPC) about the correct administration of Somulose.
The SPC strongly recommends, in particular, for horses and cattle, that you use a jugular catheter and inject the product at an appropriate speed to ensure the full dose is administered over a period of 10 to 15 seconds. In addition, Section 4.4 of the SPC: Special warnings for each target species states “Rarely, horses may show resistance to euthanasia and prior use of sedation should be considered in each case (see also under section 4.9). It is always advisable to have an alternative method of euthanasia available.” and Section 4.6 Adverse reactions: states “The recommended dose may be insufficient to achieve rapid euthanasia in some horses and this has been rarely reported.”
Furthermore, as equine vets often have to travel a lot to treat horses, it is important to ensure that the product is transported correctly in vehicles. The SPC states “Do not store above 30ºC. Do not refrigerate or freeze. Protect from frost. Protect from light."
All suspected adverse events should be reported to the MAH or the VMD. An online reporting form can be completed and submitted via the VMD website here.
Dr Gillian Diesel, Nadine Anderson
Pharmacovigilance section, Surveillance Division
Veterinary Medicines Directorate
adverse.events@vmd.gov.uk