This Is A Reversal Of March 2020 Novartis Position That Current Beovu Drug Label Provided Sufficient Warnings
According to an April 2020 news report, Novartis has said it will work with FDA, the European Medicines Agency (EMA), and other drug safety regulators around the world to issue a revised Beovu drug label with new warnings about Beovu vision-related side effects. 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 had stated that the current Beovu Prescribing Information document sufficiently addressed Beovu risks of intraocular inflammation and retinal artery occlusion.
From this April 9, 2020 BioPharma Dive news report about Beovu, "Eye drug side effects are real, Novartis confirms in new warning", we get the following:
Arterial blockages, blood vessel inflammation or severe vision loss were reported about 10 times for every 10,000 injections in March, Novartis said. The pharma will ask the Food and Drug Administration and other regulators to add new information to the product label, which could result in a "black box" warning....
In its new review of post-market adverse events reporting, Novartis found retinal artery occlusion, inflammation of blood vessels in the eye — known as vasculitis — or severe vision loss occurred in 8.75 to 10.08 out of 10,000 injections for five weeks spanning Feb. 28 to March 27.
Events causing severe vision loss such as uveitis or cataracts were most common, occurring at a rate of as high as 4.03 per 10,000 injections in the week of March 6.
Further, BioPharma Dive reporter Jonathan Gardner included this comment by RBC Capital Markets analyst Kennen MacKay in that news report:
RBC's MacKay wrote that the cases of severe vision loss and vasculitis should draw the most scrutiny from the FDA, because they haven't been reported with Eylea and other drugs using the same biological pathway such as Roche and Novartis' Lucentis and Roche's Avastin, which is used off-label.
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Last month, in this article about Beovu, "Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings", we presented the previous position taken by Novartis about Beovu vision-related side effects:
On March 2, 2020 Novartis stated that the current Prescribing Information document for its macular degeneration drug Beovu sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion. This Novartis statement about a recent Beovu safety issue is in response to a notification for eye doctors issued last week by the American Society of Retina Specialists about 11 case reports of Beovu-associated occlusive retinal vasculitis, which can lead to vision loss or blindness.
It was during February 2020 that the first news reports about the Beovu risks of intraocular inflammation and retinal artery occlusion surfaced, which we presented in this earlier article, "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug".
We will watch to see if and when Novartis issues a revised Beovu drug label with new warnings in the US, Europe, and elsewhere around the world.
We are investigating cases of severe vision loss associated with Beovu and cases of vasculitis linked to Beovu as possible drug injury lawsuits that could be filed against Novartis.
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