We recieved the following email from Zoetis concerning Librela. We want to share this information with our clients.
Dear Dr. Bode,
I’m reaching out to share an update about Librela® (bedinvetmab injection). On Monday, December 16, the FDA issued an update on the CVM website, which includes a summary and a standard agency review of adverse events reported since Librela’s U.S. launch.
Zoetis remains confident in the safety and efficacy profile of Librela, and how it is helping dogs experiencing osteoarthritis (OA) pain. Veterinarian satisfaction with the product remains high and reflects their experience treating patients with Librela.
Since March the FDA has provided three Freedom of Information Act (FOIA) reports with updates on Librela’s reported adverse events in the U.S.2 These updates are provided based on third-party requests that are made to the agency, but ultimately provide public information on what data is being reported. The information shared by the FDA is consistent with what we’ve seen in our pharmacovigilance data and what has been shared previously by the FDA in FOIA reports. As always, we ask for your help in reporting all adverse events to Zoetis as there are regulatory obligations to report to the FDA.
- To build upon the information in the FDA update, we’d like to share the following directly with you:
- Librela has undergone robust testing and has been approved as safe and effective for controlling osteoarthritis pain in dogs.
- Within the FDA Standard Adverse Event Review, there is a more detailed analysis which gives context to Librela and all of the cases reported in dogs including age distribution, and a comparison of adverse events reported with use of other OA related products.
- Zoetis is in discussions with the FDA on label updates and expects it will reflect post approval adverse event reporting and be similar to labels in other markets.
- With more than 21 million doses distributed globally, no individual adverse event sign is reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) as less than 10 per 10,000 treated animals; 1 dose = 1 treated animal).3,4
Like human health medications, there can be adverse events with any medication for animals, and it’s very important for pet owners to work closely with their veterinarian to determine the best care for their pets.
Zoetis stands firmly behind the safety of Librela and its ability to provide relief for dogs suffering from osteoarthritis pain.
For more information, please continue to join my interactive sessions for veterinarians that can be registered for here: https://www.zoetisus.com/librela-facts
Thank you for all that you do for your patients, clients, and the veterinary industry. Please feel free to reach out to me any time if you have any questions or if there is anything that I or Zoetis can do to support you.
Sincerely,
Richard Goldstein DVM, DACVIM (SAIM), DECVIM-CA
Chief Medical Officer, Zoetis
Email: [email protected]
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.
Zoetis takes all potential adverse events seriously. Reports can be submitted to VMIPS at 1-888-ZOETIS1 (1-888-963-8471), option 2, Monday through Friday, 9:00 a.m. to 6:30 p.m. EST; or online at https://www.zoetisus.com/product-support/vmips/contact-vmips.