[OAGDU] FDA publishes evaluation of adverse effects reported for canine OA treatment Librela™

[Shane Popplestone]

See the links below, I found this article, along with a link fomr the FDA on this.

I’m posting both articles I found along with their source URL’s.

FDA publishes evaluation of adverse effects reported for canine OA treatment Librela™  


FDA publishes evaluation of adverse effects reported for canine OA treatment Librela™  

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Source URL: https://www.aaha.org/newstat/publications/fda-publishes-evaluation-of-adverse-effects-reported-for-canine-oa-treatment-librela/

 

On December 16th, the  <https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela> FDA published a Dear Veterinarian letter detailing the results of the Center for Veterinary Medicine’s analysis of adverse event reporting for dogs treated with Librela (bedinvetmab).


Dear Veterinarian Letter notifying veterinarians about adverse events reported in dogs treated with Librela (bedinvetmab injection)


Source URL: https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela 

 


FDA notifies veterinarians about adverse events reported for Librela


Dear Veterinarian,

The U.S. Food and Drug Administration’s Center for Veterinary Medicine has completed an  <https://www.fda.gov/media/184483/download?attachment> evaluation of adverse events reported in dogs of various ages treated with Librela (bedinvetmab injection). The adverse events identified and analyzed include: ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, and polydipsia. In some cases, death (including euthanasia) was reported as an outcome of these adverse events. The FDA is making available reports containing summaries of clinical signs reported for Librela in the  <https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room> CVM FOIA Electronic Reading Room.


Drug Information


The FDA  <https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-monoclonal-antibody-dogs-osteoarthritis-pain> approved Librela, a monoclonal antibody drug used for the control of pain associated with osteoarthritis in dogs, on May 5, 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. 


What should a veterinarian do if a patient treated with Librela has an adverse event? 


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  <https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems> www.fda.gov/reportanimalae.

When reporting adverse events to the FDA and/or Zoetis, please include, if available, a full medical history, how many times the dog has received Librela, and the lot number on the vial used.


Where can veterinarians get more information about the adverse events that have been reported to the FDA? 


The FDA is posting reports containing adverse drug event information for Librela on a rolling basis in the  <https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room> CVM FOIA Electronic Reading Room.  If the agency has additional information to share, it will be made available.

 

 

Shane Popplestone

 <mailto:spopplestone.nfb at gmail.com> spopplestone.nfb at gmail.com

234-716-2208

You can live the life you want!

 

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