Drug label is updated for pain management therapy

Photo: yobab/Adobe Stock

Zoetis has updated the US label for Librela (bedinvetmab injection), following its submission of a supplement to the FDA, according to the company. The updated labeling is based on post-approval experience with Librela in the US since the product launched domestically in October 2023.¹

Librela is indicated for the control of pain associated with osteoarthritis (OA) in dogs. It is a once-monthly injectable monoclonal antibody that is administered by veterinary professionals.¹

“Pets are at the center of everything we do at Zoetis, and we are constantly working to support veterinarians and pet parents in ensuring they have the resources to make informed decisions for the animals in their care,” Richard Goldstein, DVM, DACVIM, DECVIM-CA, global chief medical officer and head of medical affairs for Zoetis, said in the release.¹

Label updates for pharmaceutical products are not uncommon, often occurring in the first few years after a launch and with real-world drug experience data gathered, according to Zoetis. The company has been working with the FDA to review real-world drug experience data and its own pharmacovigilance monitoring for safety and efficacy.¹

Adverse events with Librela have been reported by veterinarians and pet owners. In January 2025, the FDA alerted animal health professionals about adverse events in dogs treated with bedinvetmab injection, in a “Dear Veterinarian” letter listing neurologic signs as well as excessive thirst, urination and death.^2,3

In a public statement, Zoetis said the “Dear Veterinarian” letter was an informational update rather than a warning. “This agency review of reported adverse events is part of the FDA’s standard process following approval of any product. FDA’s communication to veterinarians is designed to inform and educate professionals and pet owners, supporting transparent and meaningful discussions about treatment decisions. The data shared with veterinarians by the FDA aligns with our own ongoing monitoring of Librela’s safety and efficacy. At Zoetis, we work closely with the FDA and other global regulatory agencies to provide context to reported events,” the statement noted.³

In a recent letter about the Librela label updates sent to veterinarians and shared with dvm360, Goldstein noted there is no change to contraindications, warnings or precautions. However, this label update includes the addition of a client information sheet, a post-approval experience section, a section of information for dog owners, and a statement in the dosage and administration section regarding the client information sheet and potential adverse events.

The client information sheet includes medication information, monitoring guidelines and when to consult a veterinarian, according to the letter. The client information sheet is available on Zoetis’ website and is being shared directly with veterinarians. The updated label and client information sheet will also be included in future distributions of the drug.¹

The company and Goldstein expressed continued confidence in the safety and effectiveness of Librela.¹ “Every medicine has potential benefits and risks, and it’s important for pet owners to work closely with their veterinarians to weigh those appropriately and maintain an open dialogue about their pets’ experiences…We stand firmly behind Librela, and the positive impact it is having on dogs that suffer from osteoarthritis pain,” Goldstein said.

Since it was approved by the FDA in May 2023, the drug has been used to treat more than one million dogs in the US. The implementation of the label update will be immediate, according to Zoetis.¹

The product was first launched 4 years ago in Europe and nearly 25 million doses have since been distributed globally, according to Zoetis. In a release, the company has said no individual adverse event signs have been reported at a rate higher than “rare” under European Medicines Agency (EMA) standards, with less than 10 occurrences per 10,000 doses.^1,3

Veterinarians previously interviewed by dvm360 have also stood by the drug’s safety and efficacy. Although some post-injection adverse effects such as itching, loss of appetite, and head tremors were reported in some cases, they saw no serious adverse effects in these patients, while quality of life was noticeably improved.⁴

Zoetis is continuously providing veterinarians with resources that include data, research and access to leading OA experts, according to the company. More than 1000 medical education webinars have been hosted by Zoetis in the past year to support veterinarians’ knowledge and understanding of how to use its products. The company has also held frequent Librela ‘office hours’ with Goldstein to address questions from veterinarians, and has field veterinarians assigned to regions in the local markets it operates in to provide additional support.¹

References

1. Zoetis announces US label update for Librela (bedinvetmab injection), a treatment to control canine osteoarthritis (OA) pain. News release. Zoetis. February 4, 2025. Accessed February 4, 2025. https://investor.zoetis.com/news/news-details/2025/Zoetis-Announces-U.S.-Label-Update-for-Librela-bedinvetmab-injection-a-Treatment-to-Control-Canine-Osteoarthritis-OA-Pain-2025-iu22I1cCqp/default.aspx
2. Bautista-Alejandre A. FDA notifies veterinarians of adverse events linked to canine osteoarthritis treatment. dvm360. January 8, 2025. Accessed February 4, 2025. https://www.dvm360.com/view/fda-notifies-veterinarians-of-adverse-events-linked-to-osteoarthritis-treatment
3. Zoetis statement on the safety of Librela. Zoetis. December 18, 2024. Accessed February 4, 2025. https://news.zoetis.com/press-releases/press-release-details/2024/Zoetis-Statement-on-the-Safety-of-Librela/default.aspx
4. Coppock K, McCafferty C, Yankowicz S. Animal health company assures veterinarians that OA drugs are safe. dvm360. April 16, 2024. Accessed February 4, 2025. https://www.dvm360.com/view/animal-health-company-assures-veterinarians-that-oa-drugs-are-safe