The U.S. Food and Drug Administrations Center for Veterinary Medicine (FDA) has issued a warning to veterinarians about an approved pain-medication for osteoarthritis in dogs. The December warning concerns Librela (bedinvetmab injection), a monoclonal antibody drug that has been approved for use in dogs since May 2023.
According to the FDA, the adverse effects from the drug include: ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, and polydipsia. In some cases, death (including euthanasia) was reported as an outcome of these adverse events.
The FDA previously determined Librela to be safe and effective for its intended use for control of pain associated with osteoarthritis in dogs based on the review of available studies.
In the FDA’s letter to veterinarians, instructions are provided for reporting adverse events:
If a dog under your care experiences an adverse event while receiving Librela, the FDA encourages you to report it to Zoetis, the drug sponsor, at 1-888‑963-8471. Drug sponsors are required to submit reports of adverse drug events to FDA. If you prefer to report directly to FDA, please see www.fda.gov/reportanimalae.
When reporting adverse events to the FDA and/or Zoetis, please include, if available, a full medical history, how many times the dog has received Librela, and the lot number on the vial used.
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