The FDA’s Center for Veterinary Medicine is investigating reports of serious adverse events, including seizures, paralysis, and death, in dogs treated with Librela, a monoclonal antibody medication for osteoarthritis pain. While not definitively linked to the drug, these reports warrant further investigation and potential labeling updates.
Librela, containing the active ingredient bedinvetmab, was approved by the FDA in 2023 as the first monoclonal antibody treatment for osteoarthritis pain in dogs. It works by inhibiting canine nerve growth factor (NGF), a protein involved in pain regulation. Initially, common side effects included infections, rash, vomiting, and weight loss.
However, as of March 2024, the FDA has received 3,674 adverse event reports associated with Librela, predominantly in older dogs, a common demographic for osteoarthritis. These reports include serious events like ataxia (loss of muscle control), seizures, diarrhea, paralysis, and even death or euthanasia shortly after administration. One reported case involved a 10-year-old Great Pyrenees that developed ataxia, incontinence, and progressive paralysis leading to death within days of receiving Librela.
While the FDA acknowledges that a causal link between Librela and these adverse events hasn’t been established, they’ve dismissed the suggestion by Zoetis, the drug’s manufacturer, that negative social media publicity inflated the number of reports. The FDA firmly stated in their review, “There is no evidence that the cases being reported are not true cases associated with Librela.”
Zoetis responded to the FDA’s letter, criticizing media portrayals of the communication as a “warning” rather than an “informational update.” They cited data from the European Union suggesting the rarity of such adverse events. Zoetis maintains confidence in Librela’s safety and efficacy, emphasizing their commitment to helping dogs live with less pain.
Further research is needed to confirm the connection between Librela and these serious side effects. The FDA has recommended that Zoetis update Librela’s labeling to include these potential adverse events, although the Center for Veterinary Medicine lacks the authority to mandate such changes. Zoetis, while defending their product, confirmed ongoing discussions with the FDA regarding potential labeling revisions.
Both the FDA and Zoetis encourage dog owners and veterinarians to continue reporting any adverse events related to Librela use. This ongoing monitoring will be crucial for assessing the drug’s long-term safety profile and ensuring the well-being of canine patients.
In conclusion, while Librela offers a novel approach to managing osteoarthritis pain in dogs, the recent reports of serious adverse events necessitate careful consideration. Further investigation and transparency are vital to ensuring the responsible and safe use of this medication. The FDA and Zoetis are working together to gather more information and provide updates as they become available. Pet owners and veterinarians are encouraged to remain vigilant and report any concerns.
