Comment from Matthew Brunke

I am Matthew W. Brunke, DVM, CCAT, Diplomate of the American College of Veterinary Sports Medicine and Rehabilitation (Canine), and Fellow of the International Association of Veterinary Rehabilitation and Physical Therapy. My clinical practice is devoted to the diagnosis and management of canine orthopedic and neurologic disease, including osteoarthritis. I routinely evaluate dogs before, during, and after treatment with multiple osteoarthritis therapies, including NSAIDs, intra-articular therapies, rehabilitation, and anti-nerve growth factor (NGF) monoclonal antibodies. I have reviewed the citizen petition and am commenting specifically on the requests for enhanced pharmacovigilance, additional post-approval safety studies, and improved clinician guidance. My comments are based on my clinical experience, published research, and my involvement as a co-author of a recent peer-reviewed study evaluating musculoskeletal and neurologic adverse event reports associated with bedinvetmab (Librela) in the Journal of the American Veterinary Medical Association. Anti-NGF therapy represents an important therapeutic option for many dogs with osteoarthritis. In appropriately selected patients, bedinvetmab can provide meaningful pain relief and improve mobility and quality of life. Preserving access to effective analgesic options remains important, particularly for patients that cannot tolerate NSAIDs or have contraindications to other medications. However, continued availability of an effective therapy should not preclude rigorous post-market safety evaluation. Clinical trials conducted before approval necessarily involve relatively small numbers of carefully selected patients and limited follow-up. Rare adverse events, delayed complications, uncommon comorbidities, and interactions with concurrent diseases often become apparent only after widespread clinical use. Our recent JAVMA publication identified statistically significant musculoskeletal and neurologic safety signals within the FDA adverse event reporting database. Importantly, these findings do not establish causation. Spontaneous reporting systems are designed for signal detection and are subject to reporting bias, incomplete clinical information, and lack of denominator data. Nevertheless, they remain one of the FDA's primary tools for identifying safety concerns that merit further investigation. For this reason, I support several aspects of the petition that would strengthen the evidence base without unnecessarily restricting access to treatment. Specifically, I recommend that FDA: Continue enhanced pharmacovigilance and periodic independent analyses of adverse event reports associated with bedinvetmab. Encourage or require prospective post-approval studies that evaluate long-term safety in real-world canine populations, including dogs with concurrent neurologic disease, advanced orthopedic disease, and common medical comorbidities that are often excluded from pre-approval trials. Continue updating product labeling as new evidence becomes available so veterinarians can make informed risk-benefit decisions. Recent label modifications regarding neurologic disease demonstrate that post-market surveillance can meaningfully improve prescribing guidance. Encourage standardized reporting of suspected adverse events by veterinarians, including complete neurologic examinations, orthopedic diagnoses, concurrent medications, imaging findings when available, and clinical outcomes. Improved report quality will substantially increase the usefulness of pharmacovigilance data. I do not believe spontaneous adverse event reports alone should be used to conclude that bedinvetmab causes every reported event, nor do I believe they justify removing an important therapeutic option from veterinarians and owners without stronger evidence. At the same time, it would be inappropriate to dismiss consistent safety signals solely because spontaneous reporting systems cannot establish causality. The appropriate regulatory response lies between these two positions. Continued access to bedinvetmab can coexist with more robust surveillance, transparent communication, stronger labeling where supported by evidence, and well-designed prospective studies that better define which patients benefit most and which may be at increased risk. The ultimate objective should be to improve patient safety while preserving therapeutic options through evidence-based regulatory oversight. Additional high-quality data will allow veterinarians and pet owners to make more informed decisions and will strengthen confidence in whichever conclusions future evidence supports. Reference von Pfeil DJF, et al. Bedinvetmab (Librela/Beransa) in dogs raises safety concerns, including rapidly progressive osteoarthritis, and warrants vigilant adverse event reporting. J Am Vet Med Assoc. 2026 Jun 26:1-11. doi: 10.2460/javma.26.03.0170. PMID: 42361372.