In-depth assessment of selected adverse events for 'Librela Solution for Injection for Dogs'
Results of in-depth assessment of reports of death, arthritis and human exposure following administration of Librela in dogs in the United Kingdom.
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Background
The VMD constantly reviews adverse event report data to ensure that the overall benefits of each UK licensed veterinary medicine product outweigh the risk posed by their potential adverse events.
The VMD continues to be aware of concerns raised in relation to serious adverse events in dogs administered Librela [1]. VMD’s Director of Authorisations and Deputy Chief Executive Officer has recently published a statement outlining our current position on the safety of this product.
As part of our surveillance activities, we have completed an in-depth assessment of adverse event reports, where the following were reported:
- Death
- Arthritis (specifically in relation to faster than expected progression of arthritis)
- Human exposure
We have also carried out routine assessment of reports involving lack of efficacy, recumbency, muscle weakness, tremor and lameness.
Events reported to MAHs and the VMD are coded using the globally standardised dictionary for Veterinary Dictionary for Drug Regulatory Affairs Activities (VeDDRA) which can be found at VeDDRA.
Data used in these analyses included either partial or complete United Kingdom adverse event report data that was received between the date of authorisation and July 2025.
About the product
Librela Solution for Injection for Dogs is an authorised injectable veterinary medicinal product containing the active substance bedinvetmab. It is indicated for the alleviation of pain associated with osteoarthritis in dogs.
[1] This includes:
- Librela 5 mg Solution for Injection for Dogs
- Librela 10 mg Solution for Injection for Dogs
- Librela 15 mg Solution for Injection for Dogs
- Librela 20 mg Solution for Injection for Dogs
- Librela 30 mg Solution for Injection for Dogs