Personal Injury Law

New Beovu Warnings for Endophthalmitis and Retinal Detachment as well as Retinal Vasculitis, Retinal Vascular Occlusion

(Posted by Tom Lamb at DrugInjuryWatch.com)

In June 2020 Novartis revised the Prescribing Information for Beovu to add new warnings for some vision-related side effects linked to Beovu. In this earlier article, "Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020", about that Beovu label change we focused on the new warnings about Beovu-associated retinal vasculitis and/or retinal vascular occlusion. Now, as regards the Beovu eye drug safety issue of vision loss, we look at the Beovu-associated endophthalmitis and Beovu-associated retinal detachment side effects.

From the new Beovu drug label, or "Full Prescribing Information (Revised: 6/2020)" document, in the WARNINGS AND PRECAUTIONS, here is the Beovu-associated endophthalmitis and Beovu-associated retinal detachment side effects warning:

5.1 Endophthalmitis and Retinal Detachment

Intravitreal injections, including those with BEOVU, have been associated with endophthalmitis and retinal detachment [see Contraindications (4.1) and Adverse Reactions (6.1)]. Proper aseptic injection techniques must always be used when administering BEOVU. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately [see Dosage and Administration (2.4) and Patient Counseling Information (17)].

As the retinal detachment is a more easily understood medical condition, we will take a closer look at the Beovu-associated endophthalmitis side effect part of the Beovu eye drug safety issue of vision loss in this article.

To start, here is the definition of endophthalmitis from EyeWiki, a service of the American Academy of Ophthalmology.

Endophthalmitis is a purulent inflammation of the intraocular fluids (vitreous and aqueous) usually due to infection.

• Serious intraocular inflammatory disorder resulting from infection of the vitreous cavity
• Progressive vitritis is the hallmark of any form of endophthalmitis
• Histologically: massive infiltration of the vitreous cavity with inflammatory cells

For some information about Beovu-associated endophthalmitis we turn to an article published in August 2020 by the American Journal of Ophthalmology, ominously titled "Is This a 737 Max Moment for Brolucizumab?":

[S]oon after the widespread community adoption of [Beovu (brolucizumab)], sporadic reports began to surface that patients were experiencing severe sterile inflammation that could be difficult to distinguish from infectious endophthalmitis. Although cases of severe sterile noninfectious intraocular inflammation have been reported following the injection of other anti-VEGF drugs, this [Beovu (brolucizumab)]-associated inflammation was unusual because it was associated with an occlusive vasculitis and irreversible severe vision loss, albeit rare. This unpredictable severe inflammation could develop weeks after the last [Beovu (brolucizumab)] injection even if previous injections of [Beovu (brolucizumab)] were well tolerated, so previous [Beovu (brolucizumab)] injections without inflammation were no guarantee that subsequent injections would be safe.

The retinal community had not reported this type of vision-threatening occlusive retinal vasculitis after intravitreal injections of other commonly used anti-VEGF drugs, such as aflibercept, bevacizumab (Avastin; Genentech, South San Francisco, California, USA), and ranibizumab (Lucentis; Genentech).... [Footnotes omitted.]

We are currently investigating drug injury lawsuits against Novartis for Beovu causing vision loss and blindness which involve Beovu-associated endophthalmitis. This is in addition to Beovu cases which involve these more well-known vision-related Beovu side effects: occlusive retinal vasculitis; retinal artery occlusion; and, intraocular inflammation.

And, of course, we continue to watch for any information released by Novartis about the findings of their panel of experts who are considering this Beovu eye drug safety issue of vision loss.

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