A “new” Beovu drug label which was revised in December 2021 sets forth some additional information about the vision-related Beovu side effects intraocular inflammation, retinal vasculitis, and retinal vascular occlusion. We point out, however, that there was no similar 2021 Beovu label change issued by Novartis in the US. From this Drug Safety … [Read more...]
Beovu: Rates of Intraocular Inflammation and Retinal Vascular Occlusion
A November 2021 article published by the medical journal JAMA Ophthalmology, “Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration”, provides new information about the incidence rates of intraocular inflammation and retinal vascular occlusion associated with Beovu (brolucizumab). This is our 19th article about Beovu … [Read more...]
Novartis Stops 3 Beovu Clinical Trials in May 2021, Wants a Beovu Label Change
In late May 2021, the latest study data concerning Beovu safety issues resulted in Novartis stopping three key clinical trials — MERLIN, RAPTOR, and RAVEN — as well as Novartis indicating there will be another Beovu label change. To see how Novartis is seeking to present the current status of its lingering Beovu safety issues as well as the next … [Read more...]
Beovu Side Effects and Beovu Lawsuits for Patients Complicate Future for Beovu
Given the serious nature and number of Beovu side effects reported to date, together with the Beovu lawsuits filed against Novartis for patients with severe vision loss, it seems fair to say that things look a bit grim for Beovu and Novartis at the start of 2021. So what does the path forward look like for Beovu? Let’s start with where things … [Read more...]
Beovu: What Comes Next for This Troubled Novartis AMD Eye Injection?
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 … [Read more...]
Beovu Retinal Vasculitis Made Worse by a Later Lucentis Treatment
A recent medical journal article presents an interesting case report about a 76-year-old woman with Beovu-related retinal vasculitis which was made worse by a later Lucentis treatment for her wet AMD. That patient's doctors are the authors of "Brolucizumab-related retinal vasculitis with exacerbation following ranibizumab retreatment: A … [Read more...]
Beovu-associated Endophthalmitis is “New” for Beovu Eye Drug Safety Issue of Vision Loss
In this article, we will look at the Beovu-associated endophthalmitis and Beovu-associated retinal detachment aspects of the Beovu eye drug safety issue of vision loss. New warnings for these vision-related side effects were added in June 2020 when Novartis revised the Prescribing Information for Beovu. In the Beovu drug label, or “Full … [Read more...]
Beovu Use Continues Despite Ongoing Beovu-associated Inflammation Investigation
A summary of the Beovu-associated inflammation safety issue is presented in this July 2020 Journal of VitreoRetinal Diseases Research Article, “Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab”. From the Abstract for this item we get these details about the current Beovu safety issue under investigation: Conclusions: … [Read more...]
Safety of Beovu Update: Study Results Announcement by Novartis and Beovu Label Change in Europe
A September 2020 announcement by Novartis about recent Beovu study results had an emphasis on the safety of Beovu. However, this is understandable in view of a February 2020 notification issued by the American Society of Retina Specialists (ASRS) which raised questions about the safety of Beovu. We get the following from this September 14, … [Read more...]
Beovu: External Safety Review Committee Findings Lead To New Vision-Related Side Effects Warnings
First, Novartis set up an internal review of Beovu vision-related side effects observed in the HAWK & HARRIER clinical trials, including rare post-marketing safety reports of vasculitis. In turn, new warnings for Beovu eye injections about retinal vasculitis and retinal vascular occlusion were added to the Beovu drug label. We take a closer … [Read more...]