Dear Valued Clients,

We are writing to address the recent FDA Dear Veterinarian letter regarding Librela, an injection commonly used to treat pain secondary to osteoarthritis in dogs. Some recent media coverage has mischaracterized the FDA’s communication as a “warning,” but it is simply an informational update to educate, not alarm. The FDA’s communication was based on anecdotal reports of adverse events; these reports are a good reason for caution and further study, but they are not very reliable in demonstrating causality, and they can be heavily influenced by press coverage and other public awareness factors.

Librela has been used safely and effectively by veterinarians for many years and is FDA-approved. The Dear Veterinarian letter was issued as a precautionary measure to inform veterinarians about a potential association between Librela and rare adverse events. “The FDA categorized the following adverse events in dogs by body system and in decreasing order of reporting frequency within each body system:

  • Neurologic: ataxia, seizures, paresis, proprioceptive deficits, paralysis
  • General: anorexia, lethargy, recumbency
  • Renal/Urinary: polydipsia, polyuria/pollakiuria, urinary incontinence
  • Gastrointestinal: vomiting, diarrhea
  • Musculoskeletal: muscle weakness, muscle tremors, lameness
  • In some cases, death (including euthanasia) has been reported as an outcome of the adverse events listed above” (Full FDA report)

It is important to note that while we want to be extremely vigilant in using Librela, the list of adverse events are unfortunately many of the commonly found issues in senior pets and Librela is most commonly used in senior patients.

Since its launch in Europe over three years ago, no individual adverse event has been reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) – representing less than 10 occurrences per 10,000 treated animals (where one dose equals one treated animal).

The FDA has not recommended that veterinarians stop prescribing Librela but instead encourages continued use with caution and monitoring for any signs of adverse events. Currently, we have multiple vets using Librela on their own animals who have seen such benefits in their pet’s quality of life that they will continue to use the medication.

At our veterinary practice, the health and well-being of your pets is our top priority. We follow all FDA guidelines and recommendations regarding the use of Librela and will work closely with you to assess the risks and benefits for your dog’s individual situation.

If your dog is currently taking Librela & you have questions or concerns, we recommend that you schedule a follow-up appointment to discuss the FDA letter and ensure that your dog’s current treatment plan is appropriate.  This new information from the FDA helps us be aware of potential adverse reactions but does not confirm that they exist.

Please do not hesitate to contact us if you have any questions or concerns.

Sincerely,

Your Veterinary Team at Town ‘N’ Country Animal Hospital