New study flags 9× higher musculoskeletal risks with Librela in dogs—what vets need to know

Musculoskeletal adverse events in dogs receiving bedinvetmab (Librela)

Mike Farrell et al.

Background

Osteoarthritis is a leading cause of chronic pain in dogs, and while treatments exist, they often involve trade-offs between efficacy and safety. Bedinvetmab (Librela), a monoclonal antibody targeting nerve growth factor (NGF), was introduced as a novel therapy for canine osteoarthritis pain. However, similar anti-NGF therapies in humans have been associated with accelerated joint degeneration, raising safety concerns. This study aimed to evaluate whether musculoskeletal adverse event reports (MSAERs) are disproportionately associated with Librela compared to other osteoarthritis medications.

Methods

The study employed a combined case–control disproportionality analysis and retrospective case series. Data were extracted from the European Medicines Agency’s EudraVigilance database (2004–2024), comparing Librela to six comparator drugs. A veterinary surgical specialist manually reviewed adverse event reports to identify relevant musculoskeletal cases. Additionally, 19 clinical cases of suspected adverse events were independently assessed by an expert adjudication panel to evaluate potential causality.

Results

Librela was associated with a markedly higher reporting rate of musculoskeletal adverse events. Specifically, ligament/tendon injuries, fractures, polyarthritis, musculoskeletal neoplasia, and septic arthritis were reported approximately nine times more frequently compared to all comparator drugs combined . Of 878 eligible adverse event reports, 90% were linked to Librela . In the case series, expert reviewers unanimously judged a strong suspicion of a causal relationship between Librela and accelerated joint destruction. Notably, severe outcomes included fractures, joint luxations, and euthanasia in some cases.

Limitations

The study relies on pharmacovigilance data, which are subject to underreporting, reporting bias, and confounding factors such as concurrent medications. The descriptive nature of the disproportionality analysis and reliance on expert judgment introduce subjectivity. Additionally, inconsistencies in adverse event reporting terminology and translation errors may affect data accuracy.

Conclusions

The findings indicate a significantly increased reporting rate of musculoskeletal adverse events in dogs treated with bedinvetmab compared to other osteoarthritis therapies. The study supports existing regulatory safety signals and suggests a potential causal association with accelerated joint damage. The authors recommend further large-scale investigations and emphasize the need for careful clinical monitoring of treated dogs.

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