The US Food and Drug Administration has issued an urgent warning on arthritis medication Librela, which is commonly being used to treat osteoarthritis in dogs. This injectable drug has been associated with severe side effects such as seizures, lameness, and loss of muscle control, which could potentially risk the health of pets.
Between January 2023 and March 2024, over 3,600 adverse health reactions have been reported, some of which may have been fatal. The FDA has issued a warning, published on Monday, to pet owners, cautioning them to be aware of the dangers posed by Librela, which could severely impact the health of affected dogs.
Pet owners should seek advice from veterinarians for alternative treatment plans and closely monitor their pets for signs of distress.
“The adverse events identified and analysed include ataxia, seizures, and 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 agency said.
Drug Information
The FDA approved Librela, a monoclonal antibody drug used for the control of pain associated with osteoarthritis in dogs, on May 5, 2023, and it was introduced to the marketplace later that year. Prior to approval, the FDA reviewed available studies and other data on Librela and determined Librela to be safe and effective for its intended use for control of pain associated with osteoarthritis in dogs. Librela is dosed by weight and labelled for subcutaneous injection once a month.
What should a veterinarian do if a patient treated with Librela has an adverse event?
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 the FDA. If you prefer to report directly to the 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.
