Case Study Further Supports Link Between Beovu and Adverse Events
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Novartis has recently identified patients with pre-existing eye conditions prior to being treated with Beovu as being at higher risk of potentially suffering from vision-threatening adverse events caused by the drug in a recent review. The discovery comes following a February 2020 warning issued by the American Society of Retinal Specialists warning patients of severe vision loss linked to the use of Beovu.
What the Novartis Review Found
In the review issued by Novartis, the main risk of experiencing vision-altering side effects such as retinal vasculitis and/or retinal vascular occlusion within the six months after the first administration of Beovu was prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu.
In more detail, according to this November 14, 2020, Reuters article, "Novartis identifies possible risk factors for Beovu patients":
The observed overall risk rate of 0.46% for all Beovu-treated patients increased to 3.97% in people who had the conditions before treatment, Novartis said.
Around the world, drug regulators are approving updated safety guidelines aimed at identifying ways to prevent severe vision loss when using Beovu. Novartis continues to uphold its position that Beovu is a valuable and important treatment option for patients with wet AMD, with an overall favorable benefit/risk profile.
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Beovu Case Study: Adverse Events Related to Beovu Injection
As mentioned previously, Beovu has been related to cases of retinal vasculitis and severe vision loss, especially with patients who have a medical history of retinal vasculitis and/or retinal vascular occlusion. A case study published in the American Journal of Ophthalmology Case Reports in December 2020 outlines the complications a 76-year old had following her Beovu injections.
Approximately one week following her third administration of Beovu, the woman experienced pain, decreased vision, and increased floaters. One month after her last Beovu injection, the patient was switched to Lucentis, a drug also aimed at treating wet AMD. Three weeks following the switch in medication, the patient experienced several adverse side effects including photophobia, pain, and decreased vision.
According to the December 2020 American Journal of Ophthalmology Case Reports article, "Brolucizumab-related retinal vasculitis with exacerbation following ranibizumab retreatment: A clinicopathologic case study", several adverse side effects were reported:
Examination was significant for 0.5+ anterior chamber cells, vitritis, mild peripheral vascular sheathing, and decreased vision from 20/70 to 20/200....
Examination revealed worsening uveitis, vitritis, vascular sheathing, and decreased vision to count fingers.
Additionally, in the same article, it was concluded the adverse events were in relation to Beovu, with no mention of Lucentis causing the vision-related issues:
Treatment with brolucizumab [Beovu] can result in intraocular inflammation and retinal vasculitis likely due to a delayed hypersensitivity reaction to the drug, supported by cytopathologic analysis of a vitreous sample. We demonstrate a case where retreatment with an alternative anti-VEGF agent resulted in worsening vision and vasculitis.
For a complete list of side effects or more information on Beovu, please visit our Beovu Drug Information Page.
We will continue to monitor the issues surrounding Beovu and provide you with any new or relevant information. Please feel free to share any information with us as well.
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