The U.S. Food and Drug Administration (FDA) has alerted veterinarians to serious adverse effects associated with Librela, a popular arthritis medication for dogs. Reported side effects include seizures, lameness, and loss of muscle control, with some cases resulting in euthanasia or death.
Key Points at a Glance:
- Adverse Effects Reported: The FDA has received over 3,600 reports of side effects linked to Librela, including neurological issues and fatalities.
- Manufacturer’s Stance: Zoetis, the manufacturer, maintains that Librela is safe and effective, noting that reported side effects represent a small fraction of the millions of doses administered.
- Regulatory Actions: The FDA recommends updating Librela’s labeling to include potential neurological, urinary, and gastrointestinal side effects.
Librela, known generically as bedinvetmab, is a monoclonal antibody treatment developed by Zoetis for managing osteoarthritis pain in dogs. Approved by the FDA in 2023, it has been widely adopted due to its targeted approach in alleviating chronic pain associated with osteoarthritis.
However, the FDA has recently issued a warning following a review of more than 3,600 cases of adverse effects reported between the previous year and March 2024. These reports detail serious side effects, including seizures, lameness, and loss of muscle control, with some cases leading to euthanasia or death.
In response to these concerns, the FDA has recommended that Zoetis update Librela’s labeling to include a “Post Approval Experience” section. This addition would detail potential neurological, urinary, and gastrointestinal side effects, providing veterinarians and pet owners with more comprehensive information to make informed decisions regarding their pets’ treatment.
Despite these reports, Zoetis asserts that Librela remains a safe and effective treatment option. The company emphasizes that the reported side effects represent a small fraction of the millions of doses administered globally. Zoetis has expressed its commitment to working closely with the FDA and is considering updating the product’s labeling to reflect the reported side effects.
Librela has become a significant product in the pet care market, with Zoetis projecting it to become a $1 billion franchise. The drug has been administered to over a million dogs in the U.S., offering relief to many suffering from osteoarthritis. However, the recent FDA warning underscores the importance of monitoring and reporting adverse effects to ensure the continued safety and well-being of pets undergoing treatment.
Pet owners are advised to consult with their veterinarians to discuss the benefits and potential risks of Librela, considering the recent FDA findings. Veterinarians should remain vigilant in monitoring patients receiving Librela and report any adverse effects to the FDA to contribute to the ongoing assessment of the drug’s safety profile.
