A recent FDA review has raised concerns about the potential for Librela, a monoclonal antibody drug for dogs with arthritis, to cause severe neurological side effects, including seizures and loss of muscle control, with some cases resulting in death or euthanasia.
Despite its approval for treating pain associated with arthritis in dogs, the review highlighted that pet owners have reported serious adverse effects after using Librela, prompting a reevaluation of the drug's safety profile by the FDA.
The FDA's analysis, based on over 3,600 adverse-event reports, does not confirm a direct causal link between Librela and the reported issues but suggests that the drug's label needs to be updated to reflect potential severe side effects.
Zoetis, the drug manufacturer, claims that the reported side effects are rare, with more than 21 million doses distributed; however, the FDA's alert to veterinarians underscores the importance of monitoring for these serious reactions.
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