The U.S. Food and Drug Administration (FDA) has issued an alert to veterinarians regarding a widely used Dog pain medication for managing osteoarthritis pain in dogs. The alert follows numerous reports of adverse side effects, including serious health complications and fatalities.
Dog pain medication Reports of Adverse Effects
The Center for Veterinary Medicine reported that the issues are associated with Librela, a monoclonal antibody drug administered through injection. This medication, approved by the FDA in May 2023, is designed to relieve pain caused by osteoarthritis in dogs.
Between May 5, 2023, and June 30, 2024, the FDA received nearly 6,000 reports of adverse side effects in dogs linked to Librela. These issues include ataxia (loss of coordination), seizures, neurologic symptoms such as paresis (partial paralysis), recumbency (inability to rise), and urinary incontinence. Other reported side effects include excessive urination (polyuria), excessive thirst (polydipsia), and even death, including cases of euthanasia.
FDA’s Stance on Librela
Before its approval, the FDA conducted a thorough review of studies and data on Librela, determining that the drug was safe and effective for its intended purpose of pain control in dogs with osteoarthritis. However, following the reports of adverse effects, the FDA has urged veterinarians to monitor dogs treated with Librela closely and report any issues to Zoetis, the drug’s sponsor.
The FDA emphasized that veterinarians play a crucial role in identifying and reporting adverse reactions to ensure ongoing safety monitoring.
Manufacturer’s Response Dog pain medication
The drug manufacturer released a statement addressing the concerns raised by the FDA alert. According to the statement, the FDA’s communication was intended as an informational update rather than a formal warning. The company stated that the adverse event data shared by the FDA aligns with its own ongoing monitoring of Librela’s safety and effectiveness.
The manufacturer expressed confidence in the drug’s safety and efficacy, reaffirming its commitment to supporting veterinarians and pet owners in managing osteoarthritis pain in dogs. They emphasized their dedication to helping dogs achieve better mobility and an improved quality of life.
What Pet Owners Should Know?
While Librela has been effective in alleviating pain for many dogs with osteoarthritis, the recent reports of adverse effects highlight the importance of vigilance. Pet owners are encouraged to consult their veterinarians about the potential risks and benefits of the medication.
If a dog experiences unusual symptoms after receiving Librela, such as difficulty walking, seizures, or changes in urination or behavior, immediate veterinary attention is recommended. Veterinarians are advised to report such cases to the drug manufacturer and the FDA to aid in ongoing safety evaluations.
Balancing Benefits and Risks
The FDA’s alert serves as a reminder of the delicate balance between the benefits and potential risks of medications for pets. While Librela remains an important tool in managing osteoarthritis pain, continued monitoring and communication between veterinarians, pet owners, and regulatory agencies are essential to ensure the well-being of dogs receiving this treatment.
