FDA Issues Serious & Life Threatening Warning on Dog Arthritis Drug LIBRELA

🛑🛑🛑 The U.S. Food and Drug Administration (FDA) has issued a warning to veterinarians regarding serious complications associated with LIBRELA, a monoclonal antibody injection used to manage osteoarthritis pain in dogs. Since its U.S. approval in May 2023, LIBRELA has been linked to adverse events including seizures, urinary incontinence, paralysis, and, in some cases, death.

AVMA

The FDA’s evaluation, which analyzed over 3,600 reports from last year through March 2024, revealed that approximately two-thirds of these adverse events occurred within the first week following administration, with 30% manifesting within the first day. Notably, 70% of these cases arose after the initial dose of Librela.

AVMA

In response to these findings, the FDA has recommended that Zoetis, the manufacturer of Librela, update the drug’s labeling to include a “Post Approval Experience” section. This addition would detail potential neurological, urinary, and gastrointestinal side effects to better inform veterinarians and pet owners.

The Wall Street Journal

Zoetis maintains confidence in Librela’s safety and efficacy, citing that adverse reactions are rare relative to the over 21 million doses administered worldwide. The company is in discussions with the FDA regarding label updates to reflect post-approval adverse event reporting, aiming for consistency with labels in other markets.

DVM360

Veterinarians are urged to monitor dogs closely following Librela administration and to report any adverse events to Zoetis or directly to the FDA. Pet owners should consult with their veterinarians to thoroughly discuss the potential risks and benefits of Librela, considering their dog’s specific health needs and medical history.

This situation underscores the importance of post-approval surveillance in veterinary medicine, as widespread use of a drug can reveal side effects not identified during initial testing. Ongoing communication between pet owners, veterinarians, and regulatory bodies is essential to ensure the safety and well-being of our canine companions.

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