VMD in-depth assessment confirms continued positive benefit-risk balance for Librela.
The Veterinary Medicines Directorate (VMD) has completed an in-depth assessment of Librela , a pain relief injection for dogs with osteoarthritis, as part of our ongoing surveillance activities. The VMD confirms that the medicine's benefits continue to outweigh the risks for most dogs treated.
Veterinary professionals are advised to review the Summary of Product Characteristics before prescribing, monitor patients carefully during treatment, and report any suspected adverse events promptly to the company with responsibility for the product - Zoetis. Dog owners should discuss any concerns with their vet and read the product information leaflet carefully. As with all veterinary medicines, if a dog appears unwell after treatment, owners should contact their vet immediately.
Gavin Hall, Director of Authorisations and Deputy Chief Executive Officer at the Veterinary Medicines Directorate, said:
The Veterinary Medicines Directorate is aware of concerns raised by some dog owners and veterinary professionals about Librela, a treatment for the alleviation of pain associated with osteoarthritis in dogs.
Based on all available evidence and our in-depth analysis, we are satisfied that the overall benefits of Librela continue to outweigh the risks for the vast majority of dogs treated with this medicine. All medicines carry a risk of potential adverse events, and monoclonal antibody products are no exception.
We take all reports of adverse events seriously. Our pharmacovigilance team continuously reviews safety data for all authorised veterinary medicines, including Librela, to ensure the benefit-risk balance remains positive. We are independently evaluating reports, assessing new data, and reviewing 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 . We will continue to review all evidence as it is reported to us and will make updates to the adverse event information contained in the product information accordingly.
Our in-depth assessment of Librela covers the following specific adverse events: death; arthritis - specifically in relation to more rapid than expected progression of arthritis; and human exposure reports. We have also undertaken routine assessment of reports involving lack of efficacy, recumbency, muscle weakness, lameness and tremor. We will be writing to veterinary professionals to provide detailed information on the outcome of our assessment and to inform them of the latest approved changes to the product information.
Librela was first authorised for use in the UK in November 2020. As with all veterinary medicines, we carefully assess every adverse event report we receive.
We understand the distress that any adverse event can cause to both dogs and their owners. The data shows that the frequency of adverse events reported in the UK following Librela administration is uncommon, occurring in 1 to 10 animals per 1,000 estimated animals treated. Reports of death following Librela administration are rare, occurring in 1 to 10 animals per 10,000 estimated animals treated. Many dogs experience significant improvement in their symptoms following treatment.
It is important to understand that Librela is primarily used in older dogs, many of whom have multiple health conditions and are taking other medications. This makes it more difficult to establish whether adverse events are directly caused by Librela. This complexity is an important factor that veterinary professionals consider when prescribing.
For veterinary professionals, please continue to follow the recommendations in the Summary of Product Characteristics, monitor your patients carefully, and report any adverse events directly to Zoetis. Dog owners are also encouraged to report adverse events to Zoetis, if you have concerns about your dog's treatment, speak to your veterinarian and carefully read the Product Information Leaflet which can be found in our Product Information Database .
The VMD's role is to protect animal health and welfare. We will continue to monitor Librela closely and will take action if the evidence shows the risks of the product outweigh the benefits.
Notes
- Please see VMD's full analysis on the post-authorisation safety of Librela
- The SPC and associated product information for Librela, including a list of Post Authorisation Assessments that resulted in changes to this information since the product was first authorised, can be found on the VMD's Product Information Database.
- To report an adverse event, we would advise veterinary professionals to contact the Marketing Authorisation Holder (MAH) (pharmaceutical company) for the product. Animal owners should contact their veterinary practice and/or report directly to the MAH for the product .
- The MAH has a legal responsibility to establish and maintain a system for collecting, collating and evaluating information in relation to adverse events, which facilitates the coordinated capture of comprehensive adverse events data, including essential follow-up information, required for robust safety assessment. The MAH must report this information to the VMD within 30 days of awareness.
- When reporting adverse events to the MAH, please ensure that you include as much information as possible regarding the event including: the relevant medical history; all concomitant medications; start date (and end date if applicable) of administration; and 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.
- Pharmacovigilance updates are published on the gov.uk page Urgent safety updates for veterinary medicines . 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. In addition, changes to authorisations most relevant to vets are published monthly in the Vet Record (the official journal of the British Veterinary Association).
