The US Food and Drug Administration has published a letter detailing the results of their analysis of adverse event reports for dogs treated with Librela, a monoclonal antibody treatment for osteoarthritis pain.
According to the FDA’s Center for Veterinary Medicine, nearly 4 in 10 dogs with OA pain do not receive treatment, but Librela has been approved by the FDA since May 2023 and Europe in 2020.
The analysis found that reported signs included ataxia, seizures, urinary incontinence, and death. Officials recommended adding a Post Approval Experience section to the current label, which advises of potential adverse effects.
Richard Goldstein, Global Chief Medical Officer for Zoetis, stated that the FDA felt there was enough information about Librela’s potential side effects not on the current label at the time of approval. He emphasized that the contraindications remain the same and encouraged veterinarians to have a risk-benefit conversation with pet owners before prescribing the treatment.
Veterinarians can consult with local representatives and access educational content for guidance on using Librela safely. If a dog experiences adverse effects, they should report it to Zoetis, which is required to submit reports to the FDA.
Source: https://www.aaha.org/newstat/publications/fda-publishes-evaluation-of-adverse-effects-reported-for-canine-oa-treatment-librela