Librela Update

On February 4th, I received an email from Zoetis:

[Anything in Italics is directly from the email. I insert quotes from the actual product label.]

Dear Doctor Beug,

I’m reaching out to share an important update about Librela (bedinvetmab injection). Zoetis has submitted a supplement to the U.S. Food and Drug Administration (FDA) to update the Librela label, incorporating post-approval experience since its launch in the U.S. in October 2023. The label has been updated to provide current information on real-world drug experience reporting.

Label updates in the pharmaceutical space are not uncommon, particularly in the first few years following a product’s launch, as additional real-world drug experience data becomes available. The revised label, which can be found at www.LibrelaPI.com, reflects reported adverse events from dogs treated with Librela in the U.S.

What’s New?

The updates to the label include:

•A statement was added to the beginning of the Dosage and Administration section regarding the Client Information Sheet and potential adverse events

Per Label: “DOSAGE AND ADMINISTRATION Always provide the Client Information Sheet and discuss potential adverse drug events with the dog owner prior to administering each injection of LIBRELA (see Post-Approval Experience and Information for Dog Owners).”

•Addition of a post approval experience section

Per Label: “Post-Approval Experience (2025) The following adverse events are based on post-approval adverse drug experience reporting for LIBRELA. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events in dogs are categorized in order of decreasing reporting frequency by body system and in decreasing order of reporting frequency within each body system:

Neurological: ataxia, seizures, paresis, proprioception deficits, paralysis

General: anorexia, lethargy, recumbency

Urinary: polydipsia, polyuria/pollakiuria, urinary incontinence

Gastrointestinal: vomiting, diarrhea

Musculoskeletal: muscle weakness, muscle tremors, lameness

In some cases, death (including euthanasia) has been reported as an outcome of the adverse events listed above.”

•Addition of an Information for Dog Owners section

Per Label: “INFORMATION FOR DOG OWNERS Always provide and review the Client Information Sheet with the dog owner prior to each injection of LIBRELA. Advise owners of the adverse reactions that may occur following the administration of LIBRELA including balance problems, trouble walking, weakness, trouble standing, seizures, drinking more, urinating more, loss of bladder control, vomiting, and diarrhea. Owners should be advised to contact their veterinarian if any of these signs or other signs of illness are observed. Advise dog owners that serious adverse reactions can occur and result in death or euthanasia (see Adverse Reactions and Post-Approval Experience). Where a dog has not been able to exercise prior to treatment with LIBRELA, there is an increased risk of injury if the dog becomes more active after being treated with LIBRELA. Discuss an exercise plan with the dog owner to return the dog to activity.”

•Addition of a Client Information Sheet

SEE BELOW

There is no change to the contraindications, warnings or precautions on the Librela label.

To further support you and your clients, a Client Information Sheet (CIS) has been added to the updated label. Since Librela is administered in-clinic, the CIS provides clients essential information about the medication, monitoring guidelines, and when to consult their veterinarian.

Zoetis remains confident in the safety and effectiveness of Librela, which has been used to treat more than one million dogs in the U.S. With nearly 25 million doses distributed globally,¹ no individual adverse event sign has been reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) – representing less than 10 occurrences per 10,000 treated animals (where one dose equals one treated animal).²

Like all medications, Librela should be prescribed based on a veterinarian’s clinical judgment, and pet owners should be encouraged to discuss any concerns with their veterinary team.

Zoetis is supporting veterinarians through real-time data, expert consultations, and educational resources to help make informed decisions about pain management for dogs.

Join Our Librela Office Hours
For more information, please continue to join my interactive sessions for veterinarians that can be registered for here: https://www.zoetisus.com/librela-facts.

Thank you for your dedication to veterinary medicine and the well-being of your patients. Please feel free to reach out with any questions or if there’s anything Zoetis can do to support you.

Sincerely,

Richard Goldstein, DVM, DACVIM (SAIM), DECVIM-CA
Chief Medical Officer,
Zoetis Email: richard.goldstein@zoetis.com Zoetis edited the label for Librela and issued a Client Information Sheet so that clients may be informed, and thus, make some kind of informed consent before giving this gene product to their dogs.

Here is the CLIENT INFORMATION SHEET with updated information highlighted:

Librela has been on the market in the US for over a year and now we get updates, instructing veterinarians to talk to clients about the adverse effects and that serious adverse events may lead to death or euthanasia.

Why has over a year gone by for them to admit there are adverse effects? But are they really admitting that? There is a clause about establishing a cause-and-effect relationship. What most pet parents do not realize is that pharma companies do not have to perform the same Stage 3 clinical trials on new products as they have to for humans. This means that in the first couple of years, a new drug or product is on the market, the pet population, your family dog or cat, IS in the Stage 3 clinical trial if you consent to its administration.

The first year or two after a new pharmaceutical or biological product is released on the market is really the clinical trial period. The industry does not call it this, but it does not perform extensive clinical trials on animal products like it does on human pharmaceuticals. The guinea pigs are the first animals to receive it over the course of a couple of years.

When I made this discovery early in my veterinary career, I made it a point to wait a year or two before prescribing new drugs to my patients, especially the ones that sounded too good to be true.

Office Hours

In honor of these new label additions, I signed up for office hours with Zoetis's Chief Medical Officer because I wanted to hear how Zoetis was marketing this product to trusting veterinarians. It has been very difficult to wrap my head around all of the gas-lighting that is going on between Zoetis and veterinarians and between those veterinarians and pet owners with collapsing dogs and cats.

I keep hearing the mantra, over and over, that clients are being told, “ It cannot possibly be the Librela.”

The CMO emailed a letter to all veterinarians announcing the changes and ensuring they had nothing to worry about and could continue injecting Librela as they had been doing so far. “There is no change to the contraindications, warnings, or precautions on the Librela label.” 

There is nothing to see here, or is there? 

Questions had to be submitted beforehand, and of course, my question, “How can we treat animals who are having adverse effects? Can we detoxify or reverse the effects?” was left unanswered.

He did say a few things that have stuck with me. One of them, as a direct quote, is “Remember, there is no proven cause and effect”, repeated several times.

One scenario he described involved an animal who had not walked for a while, getting up and exercising too much, causing damage to their joints or back because they were not feeling any pain. The owners must be told to keep the dogs quiet, were his paraphrased recommendations.

He suggested that, just as veterinarians warn owners that their pets may drink and urinate more frequently after taking prednisone, veterinarians warn the owners of dogs treated with Librela that, when they start walking again, they may “walk a little funny”.

Is he describing ataxia from neurological disease as “walking a little funny”? I could not ask him as it was a one-way conversation.

Librela-Syndrome

I have seen, and continue to see, so many dogs with the following list of symptoms post-Librela that I am calling this constellation of symptoms Librela-Syndrome:

• Balance problems, trouble walking, ataxic gate

• Weakness, difficulty standing, severe muscle weakness and/or wasting with normal neurological reflexes

• Paralysis

• Seizures

• Increased drinking water

• Urinary incontinence, loss of bladder control

• Vomiting, diarrhea, anorexia

• Cognitive decline, mental confusion, hyperesthesia

If your dog is experiencing any combination of these symptoms after being injected with Librela, the Librela most likely triggered them.

We are quickly learning how important nerve growth factor is to the functioning of the nervous system and musculoskeletal system, possibly even the pituitary gland.

The next question is whether and when your dog may recover from these symptoms. The answer is varied and very difficult to predict. Some recover, some get worse, and some will die due to the severity of the adverse effects.

I have found that some cases are responsive to acupuncture and a Chinese herbal formula prescribed specifically for the pattern of symptoms they are individually exhibiting, along with other recommendations that can be found at petadvocare.com

A Christmas Miracle

I am going to end on a positive note with a success story.

This sweet 11-year-old Lab was given 2 Librela injections. She collapsed with severe weakness in her hindquarters a few days after the second injection. She was drinking more and developing urinary incontinence. Many times, these dogs are just put on antibiotics without having a urine culture, assuming it is a urinary tract infection. All of her peripheral lymph nodes swelled up in size as well, and they went to see another conventional vet for a second opinion. He did not recognize the signs as adverse effects and convinced them to do a third Librela injection.

Within a few days, she was unable to hold herself up, her appetite decreased, and they wanted to do a full chemo protocol for lymphoma even though the biopsy of her lymph nodes was not definitive. The oncologist went so far as to blame her severe hindend weakness on the potential lymphoma.

I had them hold off on the chemo, put her on a strong “sinking Qi” herbal formula, and treated her with acupuncture and laser. The oncologist gave her one dose of a “rescue chemo drug.” Her lymph nodes went back to normal size and the urinary incontinence resolved.

We got her up and walking 3 weeks later, for Christmas!

Every case is not so lucky. Much depends upon the underlying conditions that are unveiled by this injection. My heart goes out to all the pet parents who have experienced so much trauma and grief from this product. I sincerely hope that my fellow colleagues will take another look at the warnings and read the client information sheet themselves before deciding to offer Librela as an option.