Since my July 3 post on Librela’s emerging safety profile—including data from Farrell et al.—I’ve co-authored a formal commentary with Dr. Curtis Dewey in Frontiers in Veterinary Science (July 16, 2025). In it, we expand on these concerns, address how data handling may obscure the true safety picture and offer guidance to clinicians on maintaining integrity in adverse event reporting.
Originally posted July 3, 2025, via drbrunke.wordpress.com, “Understanding the Risks and Benefits of Librela™: What Recent Research Means for Your Dog” explores both the promise and the emerging concerns about Librela (bedinvetmab), a monthly NGF-targeting injection for canine osteoarthritis. The post highlights a key study by Farrell et al., which used disproportionality analysis on post-marketing data to identify heightened risks of musculoskeletal adverse events, including rapidly progressive osteoarthritis, joint instability, muscle atrophy, and lameness, when compared with other OA therapies. These findings echo prior safety signals noted by regulatory agencies and emphasize the critical need for vigilance when using this novel treatment.
That blog post is here:
Following up on this, a General Commentary titled “Musculoskeletal adverse events in dogs receiving bedinvetmab (Librela)” was published in Frontiers in Veterinary Science on July 16, 2025, co‑authored by myself and Curtis Wells Dewey.
Key observations include:
- Elevated risk of serious musculoskeletal events: Farrell and colleagues’ analysis indicate increased occurrences of tendon and ligament injuries, polyarthritis, fractures, musculoskeletal neoplasia, septic arthritis, and accelerated joint degeneration, paralleling concerns raised in human anti‑NGF trials
- Data representation issues: You highlight a critical concern that reported adverse event (AE) descriptions often differ between veterinarian submissions and what’s recorded in EudraVigilance, due to modifications by the marketing authorization holder (Zoetis). This raises questions about the integrity of pharmacovigilance data
- Actionable recommendations for clinicians: To strengthen AE reporting and transparency, your commentary urges:
- Direct submission of reports to national authorities or the EMA.
- Verifying how submitted reports appear in regulatory databases.
- Using consistent, descriptive clinical terminology (e.g., “lameness,” “joint pain”).
- Documenting clinical signs comprehensively, including imaging, timelines, and progression, and following up on suspected discrepancies
The commentary underscores the importance of preserving data fidelity in pharmacovigilance to safeguard animal welfare, ensure regulatory accountability, and promote research that can guide safer therapeutic use.
Read the entire commentary here
https://www.frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2025.1628681/full
drbrunke 
Leave a comment