Librela (bedinvetmab injection), a monoclonal antibody drug, is a groundbreaking treatment developed to manage osteoarthritis pain in dogs. Approved by the U.S. Food and Drug Administration (FDA) in May 2023, it marked a significant advancement as the first monoclonal antibody for canine osteoarthritis pain management.

Administered monthly via subcutaneous injection, the drug is dosed by a dog’s weight, offering a tailored approach to pain relief. However, as Daily Paws reports, its promise has been overshadowed by alarming reports of severe adverse events in treated dogs.

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Librela was FDA-approved in May 2023 for osteoarthritis pain in dogs.

Adverse Effects Linked to Librela

Since Librela's U.S. launch, the FDA has received thousands of adverse event reports. Documented issues include seizures, ataxia (loss of muscle control), paresis (partial muscle impairment), and urinary incontinence. In extreme cases, death or euthanasia has followed these complications. According to the American Veterinary Medical Association, over 3,600 adverse events were recorded between its approval and March 2024, with two-thirds occurring within a week of administration. Alarmingly, 30% of these reactions appeared on the day of injection.

Librela’s neurological side effects stand out as particularly concerning. Dogs have exhibited signs of lethargy, recumbency (inability to stand), and excessive thirst and urination. Zoetis, the drug’s manufacturer, acknowledges these risks and is working with regulatory agencies to provide better context through updated labeling.

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The drug has been linked to seizures, ataxia, and paresis in treated dogs.

Pet Owners’ Dilemmas

Pet owners face difficult decisions when their dogs suffer adverse effects. Some have reported their pets declining rapidly after receiving Librela. Despite its initial promise of pain relief, the medication has left families grieving the loss of beloved companions. As Metro reports, many are questioning whether the risks outweigh the benefits.

Zoetis highlights that adverse events are rare, citing data from Europe, where Librela has been in use for over three years. The company states that no individual adverse event has occurred in more than 10 out of 10,000 treated dogs. Despite this, the FDA emphasizes the need for vigilance, as post-market surveillance can reveal previously unseen risks.

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Reports also include urinary incontinence and excessive thirst.

Veterinarians’ Responsibilities

Veterinarians are advised to carefully evaluate a dog’s health history and rule out other conditions before prescribing Librela. The AVMA reports that 30% of adverse cases involved no concurrent medications, suggesting that the drug alone may have been the trigger.

To enhance safety monitoring, veterinarians are encouraged to report adverse events directly to Zoetis or the FDA. These reports play a critical role in ongoing evaluations and in shaping future safety protocols.

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Pet owners are advised to monitor their dogs after each injection.

What Pet Owners Can Do

If your dog is being treated with Librela, monitor them closely after each injection. Daily Paws recommends watching for signs like lethargy, loss of muscle control, or changes in drinking and urination habits. Should any adverse effects appear, consult your veterinarian immediately. Owners can also report issues through the FDA’s online system or by contacting Zoetis directly.

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In some cases, adverse effects resulted in death or euthanasia.

The Path Forward

As Librela remains available, transparency between manufacturers, regulators, veterinarians, and pet owners is essential. Zoetis stresses a commitment to supporting veterinarians and pet owners, aiming to improve safety through education and collaboration.

For many pet owners, the risks of Librela represent a wake-up call. While the drug has brought relief to millions, its potential dangers underline the importance of informed decision-making.