Librela® (bedinvetmab injection): What Pet Owners Should Know About the FDA’s Warning and Reported Reactions

Librela® (bedinvetmab injection): What Pet Owners Should Know About the FDA’s Warning and Reported Reactions

Introduction

When it comes to managing pain in our pets, particularly chronic conditions like osteoarthritis, it’s natural to want relief—and fast. But with any new veterinary drug, especially biologics, it’s important to pause, look at the full picture, and ask the right questions.

Librela® (bedinvetmab injection), developed by Zoetis Inc., was approved by the U.S. Food and Drug Administration (FDA) in 2023 for use in dogs with osteoarthritis pain. It was hailed by some as a cutting-edge option, offering a new kind of pain relief through monoclonal antibody technology. But just over a year into widespread U.S. use, serious questions have emerged about its safety profile.

This article isn’t about promoting or condemning Librela—it’s about transparency. It’s about understanding what the FDA has said, what pet owners have reported, and how we can all approach veterinary medications with thoughtful awareness.

What Is Librela®?

Librela is a monthly injection designed to help control osteoarthritis-related pain in dogs. It works by targeting and neutralizing nerve growth factor (NGF), a protein involved in transmitting pain signals. Instead of being a traditional drug like an NSAID, Librela is a monoclonal antibody—a kind of biologic therapy.

Because of its novel approach, Librela was seen as a promising alternative for dogs that couldn’t tolerate NSAIDs. But it also means that the long-term, real-world safety data was still developing when it was approved.

What the FDA Shared in December 2024

On December 16, 2024, the FDA issued a “Dear Veterinarian” letter following an increase in adverse event reports tied to dogs receiving Librela. These are not isolated incidents—there were enough reports to warrant direct communication with veterinary professionals across the country.

What Has Been Reported?

Some of the most concerning adverse effects included:

• • Ataxia (loss of coordination or balance)

• • Seizures

• • Paresis (weakness or partial paralysis)

• • Recumbency (inability to rise or stay upright)

• • Urinary incontinence

• • Increased thirst and urination

• • In some cases, death or euthanasia following rapid health decline

The FDA has not made a definitive determination about cause and effect, but the agency believed the volume and nature of the reports were serious enough to notify the veterinary community and advise continued reporting.

Zoetis’ Response and Label Update

Zoetis, the maker of Librela, acknowledged the FDA’s advisory and worked with the agency to update the drug’s label. The new label includes a “Post Approval Experience” section that outlines the types of adverse events being reported. This addition doesn’t imply that the events are caused by the drug—it’s a transparency measure.

Zoetis also noted that over 21 million doses of Librela have been given globally and that the company believes the medication remains safe and effective when used as directed. However, numbers alone don’t offer much comfort to those who have watched their dog experience a sudden health decline following an injection.

An Important Reminder About Post-Approval Monitoring

Many pet owners assume that FDA approval means a drug has been proven to be safe across the board—but the reality is more complicated. When new medications hit the market, especially ones using new technology like monoclonal antibodies, the post-approval phase is where much of the real-world data comes from.

That’s why these adverse event reports are so important. The more that pet owners and veterinarians speak up, the more regulators can understand patterns, risks, and vulnerable populations.

If You’re Considering Librela

If your vet has recommended Librela, or you’ve already started using it, here are a few things to consider:

• • Have a thorough conversation. Ask your vet why this drug was chosen and what other options exist.

• • Review your pet’s history. Dogs with neurological, autoimmune, or complex health conditions may have a different risk profile.

• • Know what to watch for. If your dog experiences changes in mobility, energy, behavior, urination, or appetite after injection, don’t delay—call your vet.

• • Document everything. If something feels off, report it. Adverse events should be documented with Zoetis and/or the FDA’s Center for Veterinary Medicine.

Final Thoughts: Awareness Over Assumptions

This isn’t about panic or blame—it’s about staying informed and cautious in a space where marketing often moves faster than long-term safety data. Whether you choose Librela or not, the most important thing is to ask questions, trust your instincts, and never feel pressured into a “one-size-fits-all” solution.

Pets can’t speak for themselves. That’s why it’s our job to stay vigilant, curious, and compassionate—especially when it comes to what goes into their bodies.

Trademark Notice:
Librela® is a registered trademark of Zoetis Inc. All other trademarks are the property of their respective owners.