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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link="#467886" vlink="#96607D" style='word-wrap:break-word'><div class=WordSection1><p class=MsoNormal>See the links below, I found this article, along with a link fomr the FDA on this.<o:p></o:p></p><p class=MsoNormal>I’m posting both articles I found along with their source URL’s.<o:p></o:p></p><p class=MsoNormal style='mso-margin-bottom-alt:auto;background:white'><b><span style='font-size:24.0pt;font-family:"Arial",sans-serif;color:#2A2D33;letter-spacing:-.2pt;mso-ligatures:none'>FDA publishes evaluation of adverse effects reported for canine OA treatment Librela™ <o:p></o:p></span></b></p><h1 style='margin-top:0in;background:white'><span style='font-family:"Arial",sans-serif;color:#2A2D33;letter-spacing:-.2pt'>FDA publishes evaluation of adverse effects reported for canine OA treatment Librela™ <o:p></o:p></span></h1><div class=MsoNormal align=center style='text-align:center'><hr size=0 width=6 style='width:4.7pt' align=center></div><p class=MsoNormal style='background:white'><span style='font-size:13.5pt;font-family:"Arial",sans-serif;color:#2A2D33'><img width=1500 height=1024 style='width:15.625in;height:10.6666in' id="Picture_x0020_1" src="cid:image001.png@01DB57CA.4C920590" alt="exterior shot of the food and drug administration (FDA)"></span><span style='font-size:13.5pt;font-family:"Arial",sans-serif;color:#2A2D33'><o:p></o:p></span></p><p style='margin:0in;background:white;min-width: 0px;min-height: 0px;color:inherit;line-height:var(--lh);transition-duration: 0s !important;transition-timing-function: ;transition-delay: ;transition-behavior: ;transition-property: var(--t8n_p1);--sy: var(--syo);box-sizing: border-box'><span style='font-size:13.5pt;font-family:"Arial",sans-serif;color:#2A2D33'>Source URL: <a href="https://www.aaha.org/newstat/publications/fda-publishes-evaluation-of-adverse-effects-reported-for-canine-oa-treatment-librela/">https://www.aaha.org/newstat/publications/fda-publishes-evaluation-of-adverse-effects-reported-for-canine-oa-treatment-librela/</a></span><span style='font-size:13.5pt;font-family:"Arial",sans-serif'><o:p></o:p></span></p><p style='margin:0in;background:white'><span style='font-size:13.5pt;font-family:"Arial",sans-serif;color:#2A2D33'><o:p> </o:p></span></p><p style='margin:0in;background:white'><span style='font-size:13.5pt;font-family:"Arial",sans-serif;color:#2A2D33'>On December 16th, the <a href="https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela"><span style='border:none windowtext 1.0pt;padding:0in'>FDA published a Dear Veterinarian</span></a> letter detailing the results of the Center for Veterinary Medicine’s analysis of adverse event reporting for dogs treated with Librela (bedinvetmab).<o:p></o:p></span></p><h1 align=center style='mso-margin-top-alt:0in;margin-right:0in;margin-bottom:11.25pt;margin-left:0in;text-align:center'><span style='font-family:Merriweather'>Dear Veterinarian Letter notifying veterinarians about adverse events reported in dogs treated with Librela (bedinvetmab injection)<o:p></o:p></span></h1><p class=MsoNormal align=center style='text-align:center'>Source URL: <a href="https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela">https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela</a> <o:p></o:p></p><p class=MsoNormal align=center style='text-align:center'><o:p> </o:p></p><h2 style='background:white;box-sizing: border-box;color:inherit;margin:1rem;font-size:1.5rem;max-width:45rem'><span style='font-family:Merriweather;color:#333333;letter-spacing:.4pt'>FDA notifies veterinarians about adverse events reported for Librela<o:p></o:p></span></h2><p style='background:white;box-sizing: border-box;margin:1rem;font-size:1.125rem;max-width:45rem'><span style='font-size:10.5pt;font-family:"Helvetica",sans-serif;color:#333333'>Dear Veterinarian,<o:p></o:p></span></p><p style='background:white;box-sizing: border-box;margin:1rem;font-size:1.125rem;max-width:45rem'><span style='font-size:10.5pt;font-family:"Helvetica",sans-serif;color:#333333'>The U.S. Food and Drug Administration’s Center for Veterinary Medicine has completed an <a href="https://www.fda.gov/media/184483/download?attachment" title="Standard Adverse Event Review: Librela"><span style='color:#1E428A'>evaluation of adverse events</span></a> 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 <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room" title="CVM FOIA Electronic Reading Room"><span style='color:#1A57AD'>CVM FOIA Electronic Reading Room</span></a>.<o:p></o:p></span></p><h3 style='background:white;box-sizing: border-box;color:inherit;margin:1rem;font-size:1.375rem;max-width:45rem'><span style='font-family:Merriweather;color:#333333;letter-spacing:.4pt'>Drug Information</span><span style='font-size:13.5pt;font-family:Merriweather;color:#333333;letter-spacing:.4pt'><o:p></o:p></span></h3><p style='background:white;box-sizing: border-box;margin:1rem;font-size:1.125rem;max-width:45rem'><span style='font-size:10.5pt;font-family:"Helvetica",sans-serif;color:#333333'>The FDA <a href="https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-monoclonal-antibody-dogs-osteoarthritis-pain" title="FDA Approves First Monoclonal Antibody for Dogs with Osteoarthritis Pain"><span style='color:#1A57AD'>approved</span></a> 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. <o:p></o:p></span></p><h3 style='background:white;box-sizing: border-box;color:inherit;margin:1rem;font-size:1.375rem;max-width:45rem'><span style='font-family:Merriweather;color:#333333;letter-spacing:.4pt'>What should a veterinarian do if a patient treated with Librela has an adverse event? </span><span style='font-size:13.5pt;font-family:Merriweather;color:#333333;letter-spacing:.4pt'><o:p></o:p></span></h3><p style='background:white;box-sizing: border-box;margin:1rem;font-size:1.125rem;max-width:45rem'><span style='font-size:10.5pt;font-family:"Helvetica",sans-serif;color:#333333'>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 <a href="https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems" title="How to Report Animal Drug and Device Side Effects and Product Problems"><span style='color:#1A57AD'>www.fda.gov/reportanimalae</span></a>.<o:p></o:p></span></p><p style='background:white;box-sizing: border-box;margin:1rem;font-size:1.125rem;max-width:45rem'><span style='font-size:10.5pt;font-family:"Helvetica",sans-serif;color:#333333'>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.<o:p></o:p></span></p><h3 style='background:white;box-sizing: border-box;color:inherit;margin:1rem;font-size:1.375rem;max-width:45rem'><span style='font-family:Merriweather;color:#333333;letter-spacing:.4pt'>Where can veterinarians get more information about the adverse events that have been reported to the FDA? </span><span style='font-size:13.5pt;font-family:Merriweather;color:#333333;letter-spacing:.4pt'><o:p></o:p></span></h3><p style='background:white;box-sizing: border-box;margin:1rem;font-size:1.125rem;max-width:45rem'><span style='font-size:10.5pt;font-family:"Helvetica",sans-serif;color:#333333'>The FDA is posting reports containing adverse drug event information for Librela on a rolling basis in the <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room" title="CVM FOIA Electronic Reading Room"><span style='color:#1A57AD'>CVM FOIA Electronic Reading Room</span></a>. If the agency has additional information to share, it will be made available.<o:p></o:p></span></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><span style='font-size:12.0pt'>Shane Popplestone<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt'><a href="mailto:spopplestone.nfb@gmail.com"><span style='color:blue'>spopplestone.nfb@gmail.com</span></a><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt'>234-716-2208<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt'>You can live the life you want!<o:p></o:p></span></p><p class=MsoNormal><o:p> </o:p></p></div></body></html>