FDA Alerts Veterinarians to Health Concerns in Dogs Treated with Arthritis Drug Librela

The U.S. Food and Drug Administration (FDA) has issued a significant alert to veterinarians regarding reported health problems in dogs treated with Librela, a popular arthritis medication. This development has sparked nationwide concern among pet owners and veterinary professionals alike.

Reported Adverse Events
The FDA's Center for Veterinary Medicine has identified several serious adverse effects in dogs treated with Librela, including:

• Ataxia (poor muscle coordination)
• Seizures
• Neurological issues such as paresis and recumbency
• Urinary incontinence
• Polyuria and polydipsia

In some cases, these adverse events resulted in death or euthanasia.

Since Librela's approval in 2023, the FDA has received 3,674 reports of adverse events associated with the drug as of March 2024. These incidents have been particularly prevalent in older dogs, which is notable given that age is a known risk factor for osteoarthritis.

Librela (bedinvetmab injection) is a monoclonal antibody treatment designed to alleviate pain associated with osteoarthritis in dogs. It works by inhibiting nerve growth factor, a protein crucial in pain signal transmission. The drug was initially approved with a label listing mostly mild side effects, such as urinary tract and skin infections.

Zoetis, the manufacturer of Librela, has stated that they are collaborating with the FDA to contextualize the data and are in discussions regarding potential label updates. The company maintains confidence in Librela's safety and efficacy, citing its use in millions of dogs suffering from osteoarthritis pain globally.

This alert has validated concerns raised by pet owners who have reported severe reactions in their dogs following Librela treatment. Many families have shared distressing accounts of their pets experiencing sudden health declines or even death shortly after receiving the medication.

The FDA is urging veterinarians and pet owners to continue reporting any adverse events related to Librela use. The agency has suggested that Zoetis revise Librela's labeling to include these potential adverse effects, although it lacks the authority to mandate such changes.

While Librela has been beneficial for many dogs with osteoarthritis, this FDA alert underscores the importance of informed decision-making in veterinary care. Pet owners and veterinarians are encouraged to discuss the potential risks and benefits of Librela treatment, considering each individual dog's health status and medical history. As investigations continue, the veterinary community awaits further guidance and potential label updates to ensure the safe and effective use of this arthritis medication in canine patients