ATLANTA — Channel 2 Action News has learned that the FDA is looking at thousands of reports of health problems in dogs – including hundreds of deaths – tied to a drug for arthritis pain.
Now, Georgia pet parents say their vets never warned them about the side effects and want answers.
The families told Channel 2 investigative reporter Sophia Choi that they thought they were helping their dogs.
Instead, they’re left wondering how their pets ended up hurt or dead, after getting a shot that was supposed to give them new life.
Donna Pope says her 14-year-old French Bulldog, Gumbo, “was a little spitfire,” who ran around and ruled the house until he got a Librela injection on Dec. 29 for arthritis.
The very next day, he stopped eating. Then it got worse. Gumbo could no longer walk – paralyzed.
“You could just see he was struggling to breathe,” Pope said.
Ten days later after that one Librela shot, gumbo died.
“I was just devastated. That was my baby,” Pope said.
Zoetis, the maker of Librela told Channel 2 Action News that it has distributed 27 million doses of the drug around the world and adverse effects are rare, saying “We remain confident in the safety and effectiveness of Librela,” and “We are deeply committed to listening to – and working with – veterinarians and pet owners.”
Pope is convinced that Librela killed her dog and now, she’s warning other pet owners through a Facebook page.
Sharnae Williams believes the same thing happened to her dog, Black.
“I just started reading all the horror stories and they sounded exactly the same,” Williams said.
Black, 14, died just six days after getting a Librela shot.
“Every day I struggle. I’m sad that he went out that way,” Williams said.
The FDA approved Librela for use after the maker Zoetis conducted a study of 272 dogs in the United States, and another 281 dogs in Europe.
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“Not a very large population to identify a rare event like a death,” said Josh Sharlin, an FDA reviewer turned expert witness.
Sharlin said the government agency only looks at efficacy not safety when approving products.
“That’s why post-approval safety reporting is so important because the safety profile of a product is going to be unknown,” Sharlin said.
Choi filed a Freedom of Information Act request and found the FDA received at least 825 reports of dog deaths linked to Librela between May 2023 and June 2024.
“The deaths. I mean … you don’t get any more dramatic than that,” Sharlin said.
The FDA told Channel 2 Action News that they are “currently reviewing and assessing adverse event reports in dogs” and “widespread use of a drug product in a large number of patients may uncover adverse events.”
Dog owners like Monique Owens said their vet did not warn them about possible severe side effects.
“We’re really just playing Russian Roulette with them. My dog is not a lab rat. He’s a member of our family,” Owens said.
Her Cane Corso named Vinny is now in therapy fighting through paralysis after his second Librela shot at the end of June.
“The very next day he stumbled down the steps and it was as if he was drunk walking,” Owens said.
She believes the maker of Librela, Zoetis, failed to tell vets the truth in the US, unlike in other countries.
“I looked at the information on the Librela pamphlet for the Canada version, it actually has this exact side effect listed, but it’s not listed on the US version,” Owens said.
Librela lists side effects including urinary tract infection, anorexia, and lameness – but not death.
Zoetis said, “We gather as much relevant information as possible when potential adverse events are reported to us. We do this so we can ensure the ongoing safety of our products and report these events to the appropriate regulatory agency.”
A lot of money is at stake with Zoetis predicting Librela and a version for cats bringing in more than $1 billion in three to five years.
Like so many others, Williams regrets giving her dog Librela.
“I would have never gave it to him – ever,” Williams said.
“I got to live with the fact that I made that decision. I was in that vet’s office, and I agreed to this,” Pope said. “I carry that guilt, and I will forever.”
The pet parents Choi spoke with say they understand this drug helps a lot of other dogs, but they want Librela pulled and studied more to see why some dogs are so devastatingly affected.
FULL STATEMENT FROM FDA:
As a standard practice, the FDA monitors the safety of approved new animal drugs after approval, particularly in the first three years following approval, because widespread use of a drug product in a large number of patients may uncover adverse events not observed prior to approval. Animal drug sponsors (pharmaceutical companies) are required to report all cases of adverse events they receive from the public to the FDA.
The FDA is currently reviewing and assessing adverse event reports in dogs who received Librela and will provide further information when available. Numbers of adverse events alone do not necessarily provide a complete picture for several reasons. For example, the presence of a given report in CVM’s adverse event database does not mean that the product caused the event and CVM reviewers must assess the report(s) for potential causality. In addition, incidence rates cannot be determined using this data because the number of dogs given the product is not known. The FDA’s program policy and procedures manual for review and assessment of post-market adverse drug experience data can be found here: https://www.fda.gov/media/181019/download?attachment.
Solensia (frunevetmab injection) is a monoclonal antibody drug used for the control of pain associated with osteoarthritis in cats. It was approved by the FDA in January 2022. The FDA has been monitoring the safety profile of this drug as part of its standard practice and reviewing adverse drug event reports. If the FDA detects a safety issue with Solensia, it will provide any new information if it becomes available.
The FDA is not able to directly share information provided to the agency by a sponsor. We recommend that you contact the sponsor directly. You may also choose to file a FOIA request for this information, but it may be considered commercial confidential information.
Additional background:
Although the FDA carefully evaluates animal drugs before approval, there is the potential for new information to emerge after marketing, when the product is used in a much larger population and in settings different from the controlled studies required by the approval process. If FDA scientists detect a potential safety concern, they develop a plan of action that could include requesting that a drug sponsor make changes to the product’s labeling and working with the drug sponsor to provide more information to veterinarians and animal owners about how to use the product safely.
The FDA does not currently have the legal authority to require safety-related labeling changes for animal drugs. If the sponsor submits labeling revisions to the FDA and they are approved by the Agency, the changes will be publicly announced and posted on the FDA’s animal drug safety-related labeling changes page here: Animal Drug Safety-Related Labeling Changes | FDA.
FULL STATEMENT FROM ZOETIS:
We remain confident in the safety and effectiveness of Librela and Solensia for controlling osteoarthritis pain in dogs and cats, when used according to the label, and in the science, safety and regulatory rigor behind these products.
Since launching in Europe over three years ago, Librela and Solensia have been used effectively with millions of dogs and cats suffering from osteoarthritis pain. With more than 27 million doses distributed globally, no single sign reported in an adverse event is classified as more than rare, according to the European Medicines Agency (EMA) categorization.
We understand that when your dog or cat experiences an adverse event, these statistics are a small consolation. We are deeply committed to listening to – and working with – veterinarians and pet owners, and we take very seriously our obligation to gather as much relevant information as possible when potential adverse events are reported to us. We do this so we can ensure the ongoing safety of our products and so that we can report these events to the appropriate regulatory agency.
The significant majority of the feedback we have received from vets and pet owners continues to be positive.
Veterinarians are the best source of guidance and information for pet owners, and we continue to recommend that pet owners speak to their vets about any questions or concerns they may have.
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We also wanted to share the following background information in response to your questions.
Safety and Efficacy
Librela has been approved in more than 50 countries around the world via the extremely robust and rigorous processes of global agencies including the U.S. FDA, Health Canada and the EMA in Europe.
We work with global regulatory authorities to ensure our clinical studies have statistical significance. In two clinical studies conducted in the U.S. and the E.U., with a total of 559 dogs, Librela was shown to reduce canine OA pain, which can improve overall quality of life. Meanwhile, two clinical field studies in the U.S. and the E.U. showed that adverse events for the 273 Librela-treated dogs were similar to what would be expected for this population of dogs with OA. The most common adverse events reported in a clinical study were urinary tract infections, bacterial skin infections and dermatitis.
Before Librela, NSAIDs were the only approved medications to control osteoarthritis pain in dogs, but many dogs could not tolerate them due to pre-existing conditions. A recent head-to-head study underscored Librela’s established profile, demonstrating safety, efficacy, and fewer adverse events in the study compared to the NSAID meloxicam. (Innes, JF, et al., ESVOT 2024, Abstract) Veterinarians should rely on product labels when making clinical decisions.
In this study, the Librela-treated group had fewer adverse events as compared to the meloxicam-treated group (4 events vs 17). Adverse events do not indicate causality.
These factors continue to establish Librela as a transformative therapy for osteoarthritis (OA) pain in dogs.
Working with Regulatory Authorities
We are in regular contact with, and collaborate with regulatory agencies worldwide to ensure the ongoing safety, efficacy and quality of our products.
Label changes across pharmaceuticals are common, particularly in the first few years after a launch. Through the course of our routine interactions with regulatory agencies, we have updated the label for Librela in Australia, Canada, the EU, New Zealand, Switzerland and the UK, where Librela was approved and launched before the U.S. The FDA is constantly reviewing products across the industry as part of post-marketing review, and we have ongoing conversations with them to discuss data related to our products.
Resources for Veterinarians
Veterinarians play a critical role in both caring for pets in pain and educating pet owners about the options that are right for their pet’s needs. We provide veterinarians with many resources, including timely data, research and access to leading external and internal experts in the field of osteoarthritis. We share clear details on benefits and risks, based on the regulatory labels, through webinars, meetings and literature that they can use with their staff and pet owners.
We assign field veterinarians to local regions across the markets in which we operate to provide coaching and support. In any given year, we host over 1,000 medical education webinars for veterinarians to support their knowledge and understanding of how to use our products.
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