As we start 2021, let’s look at where things currently stand with the Beovu “safety issue” — Beovu adverse drug reactions and Beovu-related eye problems — and how we got here. In the 15 months since Beovu was approved by the FDA in October 2019, there have been numerous reports of Beovu causing occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation, often leading to vision loss and blindness.
In November 2020 Novartis said that patients with prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu. See “Novartis Update on Patients Suffering from Retinal Vasculitis and/or Retinal Vascular Occlusion After Beovu Injections“.
Two months earlier, in September 2020, stronger warnings about retinal vasculitis and/or retinal vascular occlusion were put in the Beovu drug label used in Europe. See “Safety of Beovu: A Lingering Issue Which Novartis Attempts to Counter with Recent Study Results“.
That happened three months after there was a Beovu label change here in the US. See “Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020“.
It was back in April 2020 that Novartis said it would work with drug safety regulators around the world to issue revised Beovu drug labels with new warnings about Beovu vision-related side effects. See “Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report“.
But only a month before that, in March 2020, Novartis had asserted that its original (and then current) Beovu drug labels in the US and Europe were already had sufficient warnings about the Beovu adverse drug reactions and Beovu-related eye problems associated with its (then) relatively new age-related macular degeneration (AMD) drug. See “Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings“.
And this Beovu “safety issue” all started in February 2020, when the American Society of Retinal Specialists (ASRS) issued an alert to members about 14 cases of retinal vasculitis associated with Beovu injections. See “Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug“.
So, what might happen in 2021 as regards these Beovu adverse drug reactions and Beovu-related eye problems? One thing we are anxiously waiting for is more information to be released by Novartis about the findings of their panel of experts who are considering this Beovu safety issue.
Our law firm is investigating possible Beovu lawsuits for patients who have been diagnosed with vision loss, blindness, or other serious eye problems which are Beovu side effects. Please feel free to send an email to Tom Lamb if we can be of assistance to you or someone else regarding a Beovu drug injury case. Or you can call us on our toll-free number: 800-426-9535.