The agency says the newly-approved arthritis drug may produce adverse effects
of ConsumerAffairsThe U.S. Food and Drug Administration has warned veterinarians that an often-prescribed arthritis medication for dogs may be harmful.
In a cautionary letter, the agency said it had completed an evaluation of adverse events reported in dogs of various ages treated with Librela, an injected drug with the generic name bedinvetmab.
The adverse events identified and analyzed include: ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, and polydipsia, the FDA said in the letter.
It said that in some cases, death was reported as an outcome of these adverse events.
The FDA approved Librela, a monoclonal antibody drug used for the control of pain associated with osteoarthritis in dogs, in 2023, and it was introduced to the marketplace later that year.
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. Librela is dosed by weight and labeled for subcutaneous injection once a month.
The FDA advised veterinarians to report any adverse effects of the drug to Zoetis, the drug manufacturer.
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Posted: 2024-12-20 12:55:27
