According to the June 9, 2020, FDA Beovu label change approval letter: “This Prior Approval supplemental biologics application provides for the addition of ‘Retinal Vasculitis and/or Retinal Vascular Occlusion’ to the Warnings and Precautions section of the Prescribing Information.” This Beovu label change comes after postmarketing reports of … [Read more...]
Beovu Vision Loss And Retinal Vasculitis Cases May Lead To New Warnings
There have been reports of severe vision loss associated with Beovu injections as well as cases of vasculitis linked to Beovu. In March 2020 Novartis stated that the current Beovu Prescribing Information document sufficiently addressed Beovu risks of intraocular inflammation and retinal artery occlusion. However, Novartis recently said that … [Read more...]
Beovu Warning For Retinal Vasculitis: Is Current Drug Label Sufficient “As Is”?
In late February 2020 the American Society of Retina Specialists (ASRS) seemed to assert in a notification about the macular degeneration drug Beovu that there needs to be a stronger warning about retinal vasculitis as a Beovu side effect. In early March 2020 Novartis retorted that the current Prescribing Information document for Beovu … [Read more...]
Beovu Warning: Retinal Vasculitis Which Can Lead To Blindness / Vision Loss
Beovu injections were approved by the FDA in October 2019 to treat wet age-related macular degeneration, a condition that can eventually lead to blindness. A warning about a retinal vasculitis Beovu side effect by the American Society of Retina Specialists (ASRS) in February 2020. From a February 25, 2020 article by Vantage reporter Amy … [Read more...]