FDA notifies veterinarians of adverse events linked to osteoarthritis treatment

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In a recent “Dear Veterinarian” letter, the FDA alerted veterinarians of adverse events in dogs treated with bedinvetmab injection (Librela; Zoetis). The monoclonal antibody drug is used to manage pain associated with osteoarthritis in dogs. It is dosed based on the dog’s weight and is intended for subcutaneous injection once a month.

In its letter, the federal agency listed neurologic signs like ataxia, seizures, paresis, recumbency, urinary incontinence, polyuria, and polydipsia as adverse events identified and analyzed in an FDA evaluation of adverse events.¹ Excessive thirst, urination, and even death, including euthanasia, were also documented as outcomes.²

In two-thirds of the reported events, clinical signs occurred within the first week after administration, while 30% occurred within the first day.^1,2 In 70% of the reported cases, signs were noted following the first dose of the drug. Approximately 30% of the reported cases indicated that no other products were used alongside the drug.¹

Librela received FDA approval on May 5, 2023 and was introduced to the marketplace later that year.¹ The federal agency reviewed the available studies and other data on the drug prior to its approval, and concluded that Librela was safe and effective for its intended use.¹ Since the drug’s release, however, veterinarians and pet owners have reported adverse events, leading the FDA to conduct the evaluation, according to the American Veterinary Medical Association.²

Last April, the Wall Street Journal published an article with pet owner claims of their pets experiencing adverse reactions to bedinvetmab injection and frunevetmab injection (Solensia; Zoetis) instead of the expected improvement in their conditions. One case included a 12-year-old dog that experienced decreased mobility, appetite loss, lethargy, and kidney failure before being euthanized 2 months after receiving Librela for hip stiffness.³ Similar cases involving another dog and a 16-year-old cat treated with bedinvetmab or frunevetmab were also reported, sparking attention on social media.³

“If a dog under your care experiences an adverse event while receiving Librela, the FDA encourages you to report it to Zoetis, the drug sponsor, at 1-888‑963-8471. Drug sponsors are required to submit reports of adverse drug events to FDA. If you prefer to report directly to FDA, please see www.fda.gov/reportanimalae,” wrote the FDA in its letter.¹

dvm360 spoke to Zoetis last April about reports of adverse effects in a number of patients taking Librela or Solensia (frunevetmab injection). “There are rare adverse events, like any other medication,” Richard Goldstein, DVM, DACVIM, DECVIM-CA, global chief medical officer for Zoetis, told dvm360.³ “We are very confident in the safety and efficacy of Librela and Solensia. We are very confident with the fact that [Librela] is efficacious, that it's helping thousands of dogs worldwide. But [we are] also aware that a small percentage of cases, just like any other drug, have potential side effects.”

A clinical trial involving 287 dogs found that monthly bedinvetmab injections reduced osteoarthritis pain compared to a placebo. Participants receiving bedinvetmab injection also experienced improved mobility and overall quality of life as a result of the pain relief, according to a dvm360 article.^3,4

References

1. Dear Veterinarian Letter notifying veterinarians about adverse events reported in dogs treated with Librela (bedinvetmab injection). News release. US Food and Drug Administration. Accessed January 8, 2025. https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela
2. FDA: Adverse events in dogs reported with monoclonal antibody drug. American Veterinary Medical Association. January 7, 2024. Accessed January 8, 2025. https://www.avma.org/news/fda-adverse-events-dogs-reported-monoclonal-antibody-drug?utm_source=delivra&utm_medium=email&utm_campaign=todays-headlines-news
3. Coppock K, McCafferty C, Yankowicz S. Animal health company assures veterinarians that OA drugs are safe. dvm360. April 16, 2024. Accessed January 8, 2025. https://www.dvm360.com/view/animal-health-company-assures-veterinarians-that-oa-drugs-are-safe
4. Corral MJ, Moyaert H, Fernandes T, et al. A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a canine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis. Vet Anaesth Analg. 2021;48(6):943-955. doi:10.1016/j.vaa.2021.08.001