At Zoetis, pets are at the center of everything we do. That’s why their safety and well-being, as well as the trust of veterinarians and pet parents, are our top priorities.
On Monday, December 16, the FDA shared information with veterinarians about Librela, which included a summary and agency review of adverse events reported since the product's U.S. launch. This agency review of reported adverse events is part of the FDA’s standard process following approval of any product. FDA’s communication to veterinarians is designed to inform and educate professionals and pet owners, supporting transparent and meaningful discussions about treatment decisions.
The data shared with veterinarians by the FDA aligns with our own ongoing monitoring of Librela’s safety and efficacy. At Zoetis, we work closely with the FDA and other global regulatory agencies to provide context to reported events. As part of this process, we are discussing label updates with FDA which we expect will reflect post-approval adverse event reporting and be consistent with those included on labels in other markets.
We recognize that some recent media coverage has mischaracterized the FDA’s communication as a “warning” rather than the informational update it is – a “Dear Veterinarian” letter designed to inform and educate, not alarm. It’s also important to note that the FDA’s review included no new public data on adverse reactions. This data, gathered with Zoetis’ active collaboration, underscores our commitment to understanding and supporting veterinarians and pet owners in the safe and effective use of Librela.
Since its launch in Europe over three years ago, Librela has improved the lives of millions of dogs suffering from osteoarthritis. With over 21 million doses distributed globally, no individual adverse event sign has been reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) – representing less than 10 occurrences per 10,000 treated animals (where one dose equals one treated animal).
We remain confident in Librela’s safety and effectiveness and are committed to supporting veterinarians and pet owners in helping dogs live with less pain and greater mobility.
IMPORTANT SAFETY INFORMATION: See full Prescribing Information. For use in dogs only. Women who are pregnant, trying to conceive or breastfeeding should take extreme care to avoid self-injection. Hypersensitivity reactions, including anaphylaxis, could potentially occur with self-injection. Librela should not be used in breeding, pregnant or lactating dogs. Librela should not be administered to dogs with known hypersensitivity to bedinvetmab. The most common adverse events reported in a clinical study were urinary tract infections, bacterial skin infections and dermatitis.