Confidence in the Safety and Effectiveness of Librela Based on Over 3 Years’ Experience Since Global Launch

At Zoetis, we’re dedicated to maintaining transparency and upholding the highest standards for all our products. Since launching in Europe in 2021, Librela has been a valued product by veterinarians and pet owners alike and has been used effectively in millions of dogs suffering from osteoarthritis pain.

Librela has undergone robust testing and has been proven to be a safe and effective treatment for controlling osteoarthritis pain in dogs. With 21 million doses distributed globally,1 we stand firmly behind Librela, and the positive impact it is having on dogs that suffer from osteoarthritis pain.

Always have a conversation with a veterinarian to consider the risks and benefits of adding any treatment.

Is Librela Safe for Dogs?

Librela has been approved by the FDA and similar drug agencies in other countries to be safe and effective. But every dog is different, and yours may or may not be an ideal candidate for Librela. Your veterinarian can help you come up with a treatment plan that best suits your dog.

The Approval Process

Any new drug must undergo a rigorous testing and approval process to show that it’s safe for dogs and that it consistently does what it claims to do. It can take years for a product to hit the market after testing begins.

What's The Process?

  1. Zoetis’ scientists begin formulating a new drug for a specific use in a specific animal.
  2. Extensive research is done in the lab to figure out proper dosing and to ensure the product is safe for pets and safe for the environment.
  3. Field trials are conducted on pets to further make sure the product does what it’s supposed to do and determine what the most common adverse effects are.
  4. Once these studies are completed, the results are provided to the FDA for their independent review.
  5. The FDA's team of veterinarians, scientists, toxicologists, and more review the research and, in some cases, may ask for more testing to be done.
  6. If they’re satisfied, the product is approved. Zoetis and the FDA continuously monitor the drug's safety and efficacy while it remains on the market.

Are There Side Effects With Librela?

After more than 3 years on the market in Europe and with approvals in over 50 countries, millions of doses have been given. No single adverse event sign is reported at a rate higher than rare (defined as <10 per 10,000 dogs treated).*† Your vet can help you determine if Librela is the best treatment for your dog.

As with most medicines, there are potential side effects. In clinical studies, the following were most frequently reported:2,3

  • Increased blood urea nitrogen**
  • Urinary tract Infection
  • Bacterial skin Infection
  • Skin dermititis

*EMA Veterinary product information (QRD) templates – Annex I Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/template-form/qrd-veterinary-product-information-annotated-template-english-version-91_en.pdf. Accessed 17 December 2024.

†This information has been collected after approval and is based on pharmacovigilance reports and assessments. These data are dependent on voluntary reporting by veterinarians and pet owners; therefore, underreporting occurs, and more serious adverse events may have higher rates of reporting for some products.

**For the vast majority of dogs, an elevation in blood urea nitrogen was not associated with kidney disease.

Hear from Our Experts

In a recent survey, nearly 8 out of 10 vets said they were very satisfied with Librela.5 We work closely with veterinarians to ensure they’re given the most up-to-date information about each product and to receive their firsthand feedback.

How We Monitor Side Effects

Though OA pain can affect dogs of all ages, breeds, and sizes, it often co-exists alongside other conditions, particularly in elderly dogs. We carefully monitor feedback from both vets and pet parents as we seek to better understand Librela’s role in improving dogs’ quality of life.

Have a Question About Librela?

Please refer to the full Prescribing Information for approved product labeling and Important Safety Information. Call our medical support team at 1‑888‑963‑8471 or click the link below.

IMPORTANT SAFETY 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. See full Prescribing Information.

INDICATIONS: For the control of pain associated with osteoarthritis in dogs.

References
  1. Global pharmacovigilance data on file accessed through SAP/DataMart. Sept 2024.
  2. Corral, Maria J., et al. "A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a canine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis." Veterinary anaesthesia and analgesia 48.6 (2021): 943-955. https://doi.org/10.1016/j.vaa.2021.08.001.
  3. Michels GM et al. Vet Anaesth Analg. 2023;50(5):446-458. doi:10.1016/j.vaa.2023.06.003.
  4. Willems A, Paepe D, Marynissen S, et al. Results of screening of apparently healthy senior and geriatric dogs. J Vet Intern Med. 2017;31(1):81-92. doi:10.1111/jvim.14587
  5. Librela Vet Pulse W3, March 2023, Forward Group.
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