One year ago...my first post on Librela

Keep on getting the word out on both Librela and Solensia!

In honor of the year anniversary of my first post on “the wonder drug” Librela, I am reposting the original review of the package insert and the FDA application below.

Photo by Natalie Kinnear on Unsplash

I explain step by step how I begin to evaluate a new product being put on the market and provide links to the actual package insert, FDA application, and FOI summary.

I then go line by line on what concerns me about this product, in particular the safety and efficacy studies, the number of dogs used, and the signalment of the study subjects. What is glaringly obvious is that this product was not tested on the patients it was intended for, primarily senior to geriatric dogs, many of whom have coexisting morbidities. It was studied on young, healthy beagles that had not even been vaccinated.

Then there are the red flag statements:

1. “Due to limitations of the assay methods performed to evaluate immunogenicity (confirmatory and titration), clinically relevant conclusions or correlations were not determined from the immunogenicity data reported.”

In simple English, the studies performed did not provide reliable or conclusive data on whether this product was IMMUNOGENIC, i.e. how likely it was to provoke an immune response in the body of an animal.

2. “Treatment with LIBRELA may result in the formation of anti-bedinvetmab antibodies and potentially the loss of product effectiveness”

The formation of antibodies to Librela is what results in immune-mediated reactions to Librela.

3. “The safe use of this product with other monoclonal antibodies has not been evaluated.”

One of the more common monoclonal antibody products used in dogs is Cytopoint. This is a disclaimer if any reactions occur in a dog that is simultaneously being treated with Cytopoint. I have seen cases where dogs were injected with both Cytopoint and Librela on the same day.

4. “Evaluations were not made to determine if interactions occurred between LIBRELA and veterinary vaccines.”

An unvaccinated dog is a rare exception these days. I have seen cases where the dog was vaccinated on the same day as receiving vaccines.

5. “Long-term effects which may occur more than 9 months after the use of LIBRELA have not been evaluated.”

No long-term studies were performed, even though the product is marketed with an indeterminate length of use.

6. It is unknown how Librela impacts patients with preexisting cardiovascular disease.

We see a lot of cardiac disease in older dogs.

Something not mentioned is the risk of blocking nerve growth factor in dogs with underlying neurological disease: disk herniation, spondylosis, seizure activity, peripheral polyneuropathy and laryngeal paralysis.

These are all neurological diseases that are being unmasked and accelerated in Librela dogs.

It makes you wonder what they actually did evaluate in their short period of testing.

I want to give you a short list of the most common symptoms we are seeing in Librela dogs, so you can show it to your vet after you ask them if they have read the package insert.

Most Common Symptoms seen post-injection:

• increased urination, drinking water

• pacing, disorientation, dementia

• seizures: partial, grand mal

• incontinence, house soiling

• ataxia - walking clumsily

• acute hind-end collapse, paralysis, severe weakness

• lethargic, fatigued

• decreased appetite, unable to chew or swallow

• vomiting, diarrhea

• severe muscle atrophy no matter how much they are eating

• dry eye, unresponsive corneal ulceration

• acute onset cardiac disease, cardiomyopathy

• acute onset layryngeal paralysis, peripheral neuropathy

• kidney failure

• immune-mediated reactions: anemia, loss of platelets, bleeding out

Yes, many of these symptoms are seen in geriatric dogs, but they usually do not come on suddenly or with the severity we are seeing post-Librela.

Some of these effects are seen after 1 or 2 injections, and some do not occur for months. The length of time is unpredictable.

All I want for Christmas is for people to continue sharing and getting the word out so I do not have any more calls from pet parents begging me to help save their dogs and cats after receiving these injections.

Happy Holidays!

Dr. Josie Beug