Librela is approved as safe and effective in providing control of OA pain in dogs. Librela has been on the market in Europe for more than three years and received approval from U.S. Food & Drug Administration (FDA) for its use in the U.S. in May 2023, with millions of dogs treated worldwide.¹ Extensive research is required to obtain these approvals, and Librela was evaluated rigorously to obtain regulatory approvals in multiple countries. The majority of dogs receiving Librela have benefitted from a reduction in pain.^2,3 Reduction in pain can result in increased mobility and improved quality of life.^4-6

As with all veterinary medicines or vaccines, there is always a risk of possible adverse events. Therefore, it is important to work closely with your veterinarian, who knows your dog’s health history, to understand the potential risks and benefits.

At Zoetis we take potential adverse events very seriously, and our team of veterinarians and other specialists work to understand each situation brought to our attention by veterinarians, pet owners, and regulatory authorities. We also submit information based on individual case reports which we receive to the Food and Drug Administration Center for Veterinary Medicine and other relevant regulatory agencies around the world.

As with all medicines, there are potential side effects. Pet owners should always consult their veterinarian for an accurate diagnosis and discuss the benefits and risks before embarking on any treatment. With over 14 million doses distributed over three years, Librela is approved to be a safe and effective means to control OA pain in dogs

The most common side effects that occurred in clinical studies, not just in the US, were urinary tract infections, bacterial skin infections and dermatitis.⁷ There are potential adverse events associated with all veterinary products, so it’s important to work closely with your veterinarian, who knows your dog’s health history, to understand the potential risks and benefits.

Full Prescribing Information for Librela can be found here: https://www.zoetisus.com/content/pages/Products/Dogs/Librela/Resources/documents/Librela-prescribing-information.pdf

Each country has different regulatory guidelines and expectations of what types of adverse events should be listed. We work with the regulatory agency in each country to get our products reviewed and approved according to each country’s guidelines.

At Zoetis, we take suspected adverse events very seriously, for all of our products including Librela. Our team of veterinary experts work alongside both pet owners and their attending veterinarians to understand each pet’s unique situation when brought to our attention. We know that all pets have different lifestyles, health conditions, genetics etc. and understanding all of these elements is important to evaluating a pet’s full health profile.

Zoetis also has systems in place to continuously monitor the volume and trends of adverse event reporting related to all of our veterinary medicines, including Librela. We are required to share these reports of aggregated case data to regulatory agencies around the world, and if a new safety signal emerges, we partner with regulatory authorities on appropriate actions which could include amendment of our label as necessary to better inform veterinarians and pet owners of potential risks or safety concerns to mitigate risks to the pet.

We encourage all pet owners who believe their pet may have had an adverse reaction to any medication, to contact their pet’s veterinarian first. Pet owners also need to contact Zoetis, and when they do, we document the conversation and make every effort to include the attending veterinarian in the conversation. This helps us fully understand each case and report a potential adverse effect to the appropriate regulatory body. We always encourage pet owners to also speak with their veterinarian for further consultation and advice after speaking with the Zoetis team.

Librela (bedinvetmab injection) is approved in many countries around the world, including in the U.S., EU (EEA), Canada, Brazil, Australia, UK and Japan. More information about Librela can be found here: https://www.zoetispetcare.com/products/librela