The U.S. Food and Drug Administration has issued a “Dear Veterinarian” letter notifying practitioners about adverse events reported in dogs treated with Librela (bedinvetmab injection). The monoclonal antibody drug is indicated for the control of pain associated with osteoarthritis in dogs.
The FDA’s Center for Veterinary Medicine is recommending that the current label get a “Post Approval Experience” section and that “owners be advised of the adverse reactions that may occur following administration of Librela.”
According to the FDA, the most commonly noted adverse events involved ataxia, anorexia, lethargy and polydipsia. Deaths were also reported.
Librela’s manufacturer, Zoetis, released the following statement:
“Today, the FDA issued an update on Librela, which includes a summary and standard agency review of the adverse events that have been reported since launch in the U.S.
“Safety updates, issued in the years following a product launch, serve to educate the vet and pet owners and facilitate a discussion between the two.
“The information shared by the FDA today is consistent with what we’ve seen in our pharmacovigilance data. We maintain regular communication with the FDA to ensure the ongoing safety and efficacy of our products. We have been collaborating with the FDA to help contextualize the data. Zoetis is in discussions with the FDA on label updates and expects it will reflect post approval adverse event reporting and be more similar to labels in other markets.
“We continue to have the utmost confidence in the safety and efficacy of Librela. Since launching in Europe over three years ago, Librela has been used effectively with millions of dogs suffering from osteoarthritis pain. 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 <10 per 10,000 treated animals; 1 dose = 1 treated animal).”
The FDA approved Librela’s use in the United States in May 2023.
The “Dear Veterinarian” letter is posted at bit.ly/3OWuhPl. The FDA’s Standard Adverse Event Review of Librela is at bit.ly/3DdGPyY.