(WDBJ) – The U.S. Food and Drug Administration on Monday issued an alert to veterinarians about a popular medication used to control pain associated with osteoarthritis in dogs after numerous reports of adverse side effects and death.
The Center for Veterinary Medicine says the issues were reported in dogs treated with Librela, a monoclonal antibody drug given by injection that was approved by the FDA in May of 2023.
From May 5, 2023, through June 30th, 2024, just under 6,000 reports of adverse side effects in dogs linked to the medication were reported, according to an FDA report.
Issues reported to the agency include: ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, polydipsia, and death (including euthanasia).
Prior to approval, the FDA reviewed available studies and other data on Librela and determined Librela to be safe and effective for its intended use for control of pain associated with osteoarthritis in dogs, the agency said.
The FDA said in its warning to veterinarians that if a dog in their care experiences issues it should be reported to Zoetis, the drug’s sponsor, which is required to submit reports of adverse reactions to the FDA.
Zoetis released a statement Wednesday saying media coverage “has mischaracterized the FDA’s communication as a “warning” rather than informational update it is,” adding that the data shared by the FDA “aligns with our own ongoing monitoring of Librela’s safety and efficacy.”
“We remain confident in Librela’s safety and effectiveness and are committed to supporting veterinarians and pet owners in helping dogs live with less pain and greater mobility,” the statement said.
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