The Food and Drug Administration (FDA) recently published a review of reported adverse events for Librela and I thought it was worth bringing it up in a TidBit Tuesday. Many of you prescribed Librela, and have seen wonderful results, for patients with orthopedic disease. To be clear, there are no indications to use this medication to treat neurologic disease. The preliminary studies did not identify significant neurologic risk in the population studied however this has been questioned as more data comes out. Many of you have asked me about adverse neurologic reactions to Librela and it has been a discussion of amongst neurologists as well. Well, the FDA has weighed in. This report was performed on data received prior to March 31, 2024. The review was published September 10, 2024 and I’ve attached the link here if you’d like to review it for yourself. (evaluation of adverse events)We will focus on the neurologic adverse events reported in this review but other adverse events were included in the summary.
As of 4.18.24 , 3674 cases reported Librela related adverse reactions. Ataxia was noted in 160 cases, and 27 (17%) of these were considered probably associated with Librela. Three cases had a positive rechallenge after a subsequent dose. Ataxia was reported to occur within the first week for 110 cases (70%).
Seizures were reported in 42 dogs, with 7 (17%) having a probable association with Librela. Almost 70% of the seizures occurred within the first week, and after the first dose.
Paresis was reported in 64 cases, 17 (27%) of whom were probably associated with Librela. Three had a positive rechallenge on subsequent dosing. Paresis is challenging to decide if it is orthopedic or neurologic given the indications for Librela administration. Paralysis was reported in 24 cases, 3 (12.5%) of whom were considered probably associated with Librela administration. Signs occurred in the first week for 68% of cases and after the first dose in 16 cases, but it is unclear if the 3 cases most likely to be associated with Librela were in that group.
Proprioceptive deficits were noted in 60 dogs, and 10 (17%) were considered probably associated. Approximately 65% of the cases had signs starting within the first week and after the first dose in 42% of cases.
Lastly, muscle tremors were noted in 28 cases, and 9 (32%) of these cases. Urinary incontinence has been frequently discussed amongst neurologists and this was not followed in the report.
What does this mean? It means that neurologic side effects are being reported and are considered likely to be associated with Librela. Does it mean that you shouldn’t give the medication in a dog with pre-existing neurologic signs? Not necessarily, however I personally think it is worth mentioning the risks to all owners considering starting the medication. What if a patient develops adverse effects? Report! You can report them directly to Zoetis (the manufacturer) 1-888‑963-8471 or to the FDA www.fda.gov/reportanimalae. A pre-treatment neurologic examination is strongly recommended and if adverse effects develop, a (repeated) neurologic examination is even more strongly urged. Pre-treatment examinations for orthopedic procedcures, limb amputations and now for Librela is a frequent part of my job. Please reach out if you would like to schedule a neurologic consult related to Librela administration.
Thanks for reading! I hope you have a really great week, wherever life takes you!