As we have been reporting since July 2023, Syfovre’s side effects include occlusive retinal vasculitis, a type of eye inflammation that blocks blood flow to the retina resulting in vision loss and potentially causing blindness. There have also been cases of non-occlusive retinal vasculitis and other types of eye inflammation. In late June 2024, … [Read more...]
New Syfovre Warnings for Retinal Vascular Occlusion and Retinal Vasculitis
A November 2023 label change added new Syfovre warnings for retinal vascular occlusion and retinal vasculitis cases associated with Syfovre injections. With these new Syfovre warnings, it now seems that the retinal vascular occlusion and retinal vasculitis cases associated with Syfovre use are due to the drug itself and not the injection kits, as … [Read more...]
Beovu Label Change: Novartis Adds Information, Increases Safety Warnings in February 2022
We had been watching for a second Beovu label change since May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, and, at the same time, said it would update the Beovu drug label. Finally, in February 2022, Novartis added information and increased safety warnings about various Beovu eye-related side effects, such as retinal … [Read more...]
Beovu Drug Label Revised December 2021 Was Issued in Europe, But Not in the US
A “new” Beovu drug label which was revised in December 2021 sets forth some additional information about the vision-related Beovu side effects intraocular inflammation, retinal vasculitis, and retinal vascular occlusion. We point out, however, that there was no similar 2021 Beovu label change issued by Novartis in the US. From this Drug Safety … [Read more...]
Beovu: Rates of Intraocular Inflammation and Retinal Vascular Occlusion
A November 2021 article published by the medical journal JAMA Ophthalmology, “Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration”, provides new information about the incidence rates of intraocular inflammation and retinal vascular occlusion associated with Beovu (brolucizumab). This is our 19th article about Beovu … [Read more...]