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The Beovu lawsuits claim the manufacturer of Beovu failed to adequately warn patients and doctors that use of the drug could result in vision loss and blindness.
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The company Novartis manufacturers Beovu (brolucizumab), a medication that is administered by injection. On October 7, 2019, the U.S. Food and Drug Administration (FDA) approved the drug for treatment of wet age-related macular degeneration (AMD).
In February 2020, the American Society of Retina Specialists (ASRS) issued a warning to its members regarding potential Beovu side effects. According to the ASRS, 14 cases of retinal inflammation (vasculitis) developed in patients receiving Beovu injections.
Of the affected patients, 11 had been diagnosed with occlusive retinal vasculitis, an inflammatory eye condition that can lead to blindness. One month later, these numbers increased to 25 cases of retinal vasculitis and 21 involving retinal occlusion.
What is the Key Legal Issue Involving Beovu?
The primary legal issue is whether drug manufacturer Novartis failed to adequately warn doctors and patients about the potential vision-related side effects caused by Beovu injections.
As of February 2020, Novartis had shipped more than 57,700 Beovu vials to prescribing doctors in the U.S.
The National Library of Medicine (NLM) reports several potential side effects associated with Beovu injections. The side effects can lead to serious complications, and the NLM recommends seeking emergency medical treatment if you experience any of the following symptoms:
The key side effects from Beovu injections that are part of the lawsuits include:
In February 2020, the American Society of Retina Specialists issued a warning to its members about potential Beovu side effects.
In April 2020, Novartis (the manufacturer of Beovu) announced it would be working with the FDA, the European Medicines Agency (EMA), and global drug safety regulators to revise the Beovu drug label with adequate references to Beovu’s vision-related side effects.
In June 2020, the FDA approved an update to the Beovu label. The refashioned label presents safety information regarding retinal vasculitis and retinal vascular occlusion. Specifically, Novartis added the following language to the drug’s label: “Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported following BEOVU … Patients should be instructed to report any change in vision without delay.”
The purpose of Beovu is to treat wet AMD, a condition in which abnormal vessels behind the retina begin to leak blood, lipids, and fluid. Because of the leaking, scar tissue forms, causing damage to the macula and leading to a loss of central vision.
Beovu (brolucizumab) is administered to patients via an intravitreal (inside the eye) injection to suppress the growth of abnormal blood vessels, thereby minimizing the potential for fluids leaking into the retina.
Non-ophthalmology applications of brolucizumab are under preclinical development for treating Kaposi sarcoma and glioblastoma.
According to the Mayo Clinic, vasculitis is inflammation of blood vessels. Blood vessel walls can thicken, become weaker or narrower, and scarred. As a result, the patient’s tissues and organs suffer from restricted blood flow, causing damage. In the case of retinal vasculitis, the eye becomes damaged from this inflammation.
The inflammation of the retina-based vessels in a case of retinal vasculitis can also lead to concomitant occlusion, which means that the blood flow to the eye is blocked or constricted. Both the vasculitis and the occlusion can result in a patient’s vision loss.
Data submitted premarket by Novartis referred to clinical trials in which retinal vasculitis presented in one subject who had been injected with brolucizumab (Beovu), compared with zero cases in subjects who took aflibercept (another medication used to treat wet macular degeneration). Retinal artery occlusion presented in seven of the brolucizumab (Beovu) patients, compared with one in the aflibercept patients.
In August 2020, the American Journal of Ophthalmology published an editorial written by Philip J. Rosenfeld and David J. Browning, who stated, “We have stopped using brolucizumab because of the associated inflammation. Our patients have alternatives without incurring this risk.” They pointed out that “The retinal community had not reported this type of vision-threatening occlusive retinal vasculitis after intravitreal injections of other commonly used anti-VEGF drugs.” To read more, click American Journal of Ophthalmology.
In August 2020, JAMA Ophthalmology published the observations of Sromovas Sai Kondapalli, MD, who reported about a patient with blurry vision. The condition of “clinically-significant boxcarring of the retinal arteries” coincided with a second brolucizumab injection. To read more, click JAMA Ophthalmology.
In July 2020, HHS Public Access published a study of the characteristics of 26 postmarket cases of retinal vasculitis that presented after 25 patients were administered intravitreal brolucizumab injections. The cases were reported to ASRS through April 1, 2020. To read more, click HHS Public Access.
In June 2020, the American Journal of Ophthalmology reported the study of a patient who suffered severe vision loss after receiving three injections of brolucizumab, ultimately being diagnosed with “retinal arteriolar occlusion associated with repeated intravitreal brolucizumab administrations.” The writers pointed out that data from clinical trials indicated six cases of retinal artery occlusion in brolucizumab patients, despite the fact that the published data reported only three such cases. To read more, click AJO Cases.
In June 2020, the American Journal of Ophthalmology Case Reports published reports about a patient suffering from vision loss and light sensitivity in both eyes following her Beovu injection. Researchers ran clinical and laboratory tests to rule out other causes, determining the cause to be intravitreal injection of brolucizumab. To read more, click AJO Case Reports.
In April 2020, Ophthalmology researchers reviewed 15 eyes from 12 patients who suffered retinal vasculitis after intravitreal injection of brolucizumab. The authors noted that “Brolucizumab is the first FDA-approved anti-VEGF agent associated with noninfectious retinal vasculitis after intravitreal therapy.” To read more, click Ophthalmology Magazine.
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