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A product liability lawsuit filed by a Nebraska woman indicates the side effects of Beovu, a wet macular degeneration drug, caused her to suffer permanent and serious eye injuries.
Edith Harris filed the complaint (PDF) in the U.S. District Court for the District of Nebraska on on January 19, indicating the drug manufacturers Novartis Pharmaceuticals and Alcon Research, LLC. failed to adequately warn users and the medical community about the vision risks associated with the medication when it was introduced in October 2019.
Beovu (brolucizumab) was just approved as a treatment for wet age-related macular degeneration less than 18 months ago, as part of a class of medications known as anti-vascular endothelial growth factor therapy, or anti-VEGF. However, shortly after it was introduced, a number of serious problems with Beovu were identified, with users reporting a severe form of eye inflammation, known as retinal vasculitis.
Harris indicates she suffered serious and permanent vision injuries from Beovu, including ocular inflammation, retinal vasculitis, and retinal vascular occlusion.
The case joins a growing number of Beovu lawsuits now being pursued by former users nationwide, which have all emerged since researchers with the American Society of Retina Specialists first raised concerns about vision risks associated with the medication last year.
In February 2020, the group sent warning to members about at least 14 cases of retinal vasculitis from Beovu, involving inflammation of the branches of the retinal artery. At least 11 of those cases involved a more severe instance of the inflammation known as a retinal vascular occlusion, where the vein becomes blocked and may result in permanent vision loss.
Due to the problems, some doctors have decided to stop carrying the eye drug in their inventories and the FDA required the manufacturer to add new warnings about the link between Beovu and retinal vasculitis in June 2020. However, consumers and the medical community are still trying to understand the risk.
“Defendants negligently misrepresented the safety and efficacy of Beovu in their labeling, advertising, product inserts, promotional materials, or other marketing resources and materials,” the lawsuit states. “If Plaintiff’s healthcare providers and Plaintiff had known the true facts concerning the risks of Beovu use, in particular, the risk of vision-related adverse events and/or reactions, including, but not limited to, an increased risk for intraocular inflammation, retinal vasculitis, retinal vascular occlusion and other severe vision problems, they would not have prescribed or used Beovu and would have instead prescribed and used a safer alternative pharmaceutical drug or no drug at all.”
While Novartis initially marketed and sold the drug for months without warnings about the Beovu retina problems, a warning update in June 2020 added new information to the drug label. The company is now urging patients to seek immediate care from an ophthalmologist if their eyes become red, sensitive to light, painful, or develop changes in vision.
Wet age-related macular degeneration affects about 20 million people worldwide. It is a chronic eye disorder which can caused blurred vision or blind spots. It usually occurs when abnormal blood vessels leak into the macula. The degeneration can be stopped, and sometimes vision loss can be reversed, if treated early enough.