The Pharmacovigilance team at the Veterinary Medicines Directorate (VMD) would like to communicate important information about Librela Solution for Injection for Dogs.
Should you have any comments or concerns regarding this content, please contact the VMD via postmaster@vmd.gov.uk.
“We constantly review adverse event report data to ensure that the overall benefits of each UK licensed veterinary medicinal product outweigh the risk posed by their potential adverse events.
As part of our ongoing surveillance activities, we have completed an in-depth analysis of the safety of Librela, carefully considering the concerns raised by some pet owners regarding specific adverse events.
Our in-depth assessment of Librela covers the following specific adverse events: death; arthritis – specifically in relation to more rapid than expected progression; and human exposure. We have also performed routine assessment of reports involving lack of efficacy, recumbency, muscle weakness, tremor and lameness. Additional adverse event terms are currently undergoing assessment.
We will continue to independently evaluate reports, assess new data and review ongoing and planned safety studies to ensure that the product information adequately represents the latest evidence available. For example, we recently added the event terms immune-mediated polyarthritis, paresis and paralysis to the product information in January 2026. Details can be found on our Product Information Database and recently published Librela Solution for Injection for Dogs – SPC update – GOV.UK.
The VMD is confident that the overall benefit-risk balance of the product remains positive based on the data available at this time. Many dogs experience significant improvement of their symptoms following Librela administration.
A statement from our Director of Authorisations and Deputy Chief Executive Officer on this update can be found on Gov.uk.
Reporting adverse events
We strongly encourage veterinary professionals to ensure they are following the recommendation of the Summary of Product Characteristics and, alongside owners, reporting related adverse events. The reporting of adverse events is critical to increasing the volume of data available for ongoing monitoring, and both VMD and Zoetis will continue to review adverse event reports received.
Veterinary professionals reporting an adverse event following administration of Librela should currently report the event to the relevant MAH who is Zoetis UK Limited. Please contact Zoetis using the information contained on their website, where there is an option allowing completion of a web form.
Our online reporting form previously found on our Gov.uk website is unavailable. We apologise for any inconvenience caused. The VMD is developing an advanced online adverse event reporting portal, with implementation targeted for early 2026. Future updates on the new reporting portal will be published on our Gov.uk website.
When reporting an adverse event to an MAH, please ensure that you include detailed information regarding the event, the relevant medical history, all concomitant medications, start date (and end date if applicable) of administration of Librela with dosage information, including frequency of dosing (and/or number of doses). We also recommend submitting detailed descriptions of imaging findings.
For orthopaedic cases, submission of an adverse event case to the MAH alongside provision of both pre-Librela imaging and imaging showing the adverse event is preferred; this enables the best quality data to be obtained.
The VMD does not give individual clinical advice. For advice on specific cases, general product advice or when considering off-label use, we advise veterinary professionals to contact the MAH.
Further pharmacovigilance information
We urge all vets to keep up to date with the VMD’s regular pharmacovigilance news and updates, so that you can provide the best possible care to your patients.
The VMD regularly publishes urgent and clinically significant pharmacovigilance updates on gov.uk; this also includes any updates involving non-veterinary medicines used in animals. To receive these pharmacovigilance updates via email, please click on the ‘Get emails about this page’ button.
A rolling 6-month list of Summary of Product Characteristic (SPC) changes for veterinary medicines can be found on the monthly medicines update page, and further information on veterinary medicines can be found in the Product Information Database. In addition, changes to authorisations most relevant to vets are published in the Vet Record (the official journal of the British Veterinary Association).”