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 sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion and, therefore, the current warning about retinal vasculitis is sufficient.
The ASRS notification for eye doctors said there are 11 case reports of Beovu-associated occlusive retinal vasculitis, which can lead to vision loss or blindness.
Novartis contends in its March 2, 2020 statement: “We believe the incidence of these events remains consistent with or below the package insert.”
Be assured we are watching for the FDA — as well as drug regulatory agencies in Canada, Europe, and Australia — to weigh in on this emerging Beovu safety issue.
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