Side Effects of Beovu

Side Effects of Beovu

Beovu, known scientifically as brolucizumab-dbll, is a medication developed to treat wet age-related macular degeneration (wet AMD), a serious eye condition that threatens vision. The condition causes abnormal blood vessels to form and leak within the macula, the part of the eye that allows for clear central vision. 

Beovu's introduction offered a promising solution for slowing wet AMD. It was particularly appealing because it required fewer injections than its counterparts. However, shortly after its release, reports of serious, sometimes vision-altering side effects linked to Beovu surfaced, with some patients experiencing life-changing complications like retinal vasculitis, retinal vascular occlusion, and irreversible blindness.
These adverse effects raised concerns about Beovu’s safety and led to numerous lawsuits, with many turning to Lawsuits.com for support.

What is Beovu?

Beovu, manufactured by Novartis, was approved by the U.S. Food and Drug Administration (FDA) in October 2019 to treat wet AMD. Administered via an injection directly into the eye, Beovu works by inhibiting the growth hormone vascular endothelial growth factor (VEGF), which is responsible for the growth of abnormal blood vessels. By targeting VEGF, Beovu aims to slow disease progression and preserve vision.

Despite its groundbreaking promise, Beovu’s release quickly became a source of concern. Only months after its initial approval, reports began emerging that some patients experienced rare, serious side effects not initially disclosed. These reports ultimately led the FDA to require a "black box" warning for Beovu in June 2020, cautioning users about its potential to cause retinal vasculitis and retinal vascular occlusion, severe conditions linked to significant vision loss and even blindness.

Common Side Effects of Beovu

Like all medications, Beovu can cause various side effects. Common side effects that may occur after receiving Beovu injections include:

• Blurred vision
• Eye pain
• Eye redness
• Sensitivity to light
• Floaters (small dark spots or squiggly lines in vision)
• Dry eye
• Eye irritation
• Foreign body sensation in the eye
• Cataracts
• Eye inflammation
• Increased pressure in the eye
• Eye discharge
• Watery eyes
• Itchy eyes

Most of these common side effects are mild to moderate and typically resolve on their own within a few days after the injection.

Serious Side Effects and Risks Associated with Beovu

Beovu has been linked to several serious and potentially life-changing side effects, primarily affecting the eyes. Among the most severe risks are retinal vasculitis and retinal vascular occlusion, which can lead to permanent vision loss and, in extreme cases, total blindness. These conditions, although rare, have raised significant concerns about the safety of Beovu for patients with wet age-related macular degeneration.

Retinal Vasculitis

Retinal vasculitis is a dangerous inflammatory condition affecting the blood vessels in the retina, the part of the eye responsible for processing light and transmitting visual information to the brain. Inflammation of the retinal blood vessels can restrict blood flow, potentially leading to tissue damage and a range of vision issues, from blurriness to complete blindness.

When retinal vasculitis occurs alongside retinal vascular occlusion, where blood vessels in the retina become blocked, the combined impact can be even more devastating. This blockage can cut off the retina’s access to necessary oxygen and nutrients, leading to rapid and sometimes irreversible damage. Occlusive retinal vasculitis is especially alarming because it can trigger sudden and severe vision changes, often progressing from slight blurriness to significant vision loss within hours or days.

Upon Beovu's release, initial reports documented 14 cases of vasculitis, 11 of which involved occlusion. Within a month, the number of cases escalated to 25, with 21 patients experiencing occlusion. This sharp increase led to an urgent review of Beovu's safety, ultimately prompting the FDA to add a "black box" warning, alerting users to these serious risks.

Symptoms of retinal vasculitis may include:

• Sudden blurred or distorted vision – Vision may become fuzzy or wavy as inflammation affects retinal function.
• Floaters – Dark spots or streaks may appear in the visual field, caused by clumping in the eye’s vitreous fluid.
• Light flashes – Unexplained light flashes can signal abnormal activity in the retina.
• Pain or pressure in the eye – Inflammatory reactions can cause discomfort, often described as a dull ache or sharp pain.
• Color vision changes – Retinal damage may alter how colors are perceived, creating a muted or altered color range.

For those affected, retinal vasculitis can be recurrent and difficult to control, sometimes leading to a progressively worsening condition if untreated. Patients are encouraged to monitor these symptoms closely, as early detection is critical to prevent long-term vision damage.

The original prescribing information for Beovu, released in October 2019, did not include warnings about the risk of occlusive retinal vasculitis. From its initial approval to February 2020, healthcare providers administered approximately 46,000 Beovu injections to patients who were unaware of these potential severe complications.

Retinal Vascular Occlusion

Retinal vascular occlusion, often occurring alongside retinal vasculitis, involves a blockage in the retina's blood vessels, cutting off oxygen and nutrients to parts of the retina. This condition can present suddenly and severely, as the retinal tissue deprived of blood flow deteriorates, resulting in a loss of vision that may become permanent. Retinal vascular occlusion can cause partial or complete blindness depending on the extent of the blockage and the area of the retina affected.

The symptoms of retinal vascular occlusion include:

• Abrupt vision loss – Many patients report experiencing a sudden onset of blurred or missing vision in one eye.
• Shadowed or "curtained" vision – Vision may feel obstructed by a shadow, curtain, or veil effect, making it difficult to see clearly.
• Scotoma – This term describes a blind spot in the field of vision, usually appearing as a dark or blurred area that doesn't improve with blinking.

Retinal vascular occlusion is a medical emergency, and prompt treatment is critical to prevent long-term damage. Unfortunately, even with quick intervention, some patients may experience permanent visual impairment due to the severity of the occlusion.

Severe Vision Loss and Blindness

Severe vision loss and blindness are among the most devastating consequences associated with Beovu. For patients who develop either retinal vasculitis or vascular occlusion, the likelihood of experiencing permanent vision changes increases significantly. Vision loss may vary in degree, but for many, the impairment affects daily life and overall independence, adding to the emotional and psychological toll.

The damage caused by retinal vasculitis and vascular occlusion is often irreversible, particularly if extensive areas of the retina are affected. Given the retina's complex role in visual processing, any structural damage can disrupt vision in multiple ways, leaving patients with blurred vision, blind spots, or complete vision loss.

These serious risks underscore the importance of patient awareness and close monitoring following Beovu treatment. If symptoms like blurred vision, floaters, or eye pain occur, patients should seek immediate medical attention, as early detection and intervention may help mitigate long-term effects.

Other Reported Conditions

In addition to the primary risks of retinal vasculitis and occlusion, patients receiving Beovu injections have reported inflammation, retinal artery occlusion, and eye hemorrhage, all of which can exacerbate vision issues and lead to long-term complications.

FDA's Response and Safety Reviews

The sudden influx of adverse reports led the FDA to investigate Beovu’s safety further. Working alongside Novartis, the FDA initiated a comprehensive review, ultimately confirming a correlation between Beovu injections and severe eye-related side effects. This resulted in the addition of a “black box” warning to Beovu’s labeling—the FDA’s most prominent warning level, signaling significant risks associated with the drug.

Despite the added warning, Beovu remains on the market without an official recall. This regulatory decision has been met with concern, given the drug’s potential risks. Patients who developed severe eye conditions from Beovu injections before the label change may have grounds for legal action against Novartis, given the absence of adequate warnings prior to June 2020.

Why People Are Filing Beovu Lawsuits

Several patients who suffered serious side effects from Beovu have filed lawsuits against Novartis, alleging insufficient warnings about the risks associated with the medication. These cases generally center on claims that Novartis failed to conduct adequate testing, analyze potential risks thoroughly, and disclose critical safety information in a timely manner.

Key arguments presented in Beovu lawsuits include:

• Failure to Warn: Patients assert that Novartis did not provide adequate information on the risks of retinal vasculitis and vascular occlusion. Patients who received Beovu before the black box warning was added in June 2020 claim that Novartis’s labeling did not sufficiently warn them of these serious risks, resulting in preventable harm.
• Negligence in Research: Allegations also suggest that Novartis did not conduct rigorous enough testing during Beovu’s development, potentially overlooking the scientific indicators of serious risks associated with the drug.
• Post-Market Surveillance: Many lawsuits claim that Novartis failed to adequately monitor the real-world effects of Beovu following its release, which may have delayed the identification of safety risks and the implementation of necessary warnings.

For those who experienced vision loss due to Beovu injections, these lawsuits offer a pathway to seek compensation for medical expenses, loss of income, and other damages related to their injuries.

Who May Qualify for a Beovu Lawsuit?

Individuals who experienced adverse reactions to Beovu, particularly retinal vasculitis, retinal vascular occlusion, or vision loss, may qualify to file a lawsuit against Novartis. Eligibility is often strongest for patients who:

• Received Beovu injections before June 2020 – When Novartis added the black box warning, it shifted some responsibility for disclosure onto healthcare providers, but patients treated prior to this change had no official warning.
• Suffered a qualifying injury – Those who were diagnosed with conditions such as retinal vasculitis or retinal vascular occlusion and have medical documentation of the injury may be eligible.

Each case is unique, so consulting with an attorney familiar with Beovu lawsuits can clarify eligibility and determine what legal avenues may be available.

Compensation Available in a Beovu Lawsuit

Patients who have suffered serious side effects from Beovu, such as retinal vasculitis, retinal vascular occlusion, or significant vision loss, may be eligible for compensation through a lawsuit. Compensation in these cases generally covers a range of damages intended to address the financial, physical, and emotional impacts of these injuries.

• Medical Expenses: Plaintiffs may recover costs related to past, present, and future medical treatments, including surgeries, medications, hospital stays, and rehabilitation to address eye-related complications.
• Lost Income and Reduced Earning Capacity: Vision loss can significantly affect one’s ability to work. Compensation may include lost income and any future earnings that could be affected by permanent vision impairment.
• Pain and Suffering: This non-economic damage aims to compensate for the physical pain and emotional distress associated with vision loss and the lasting challenges it brings.
• Loss of Quality of Life: Vision impairment impacts daily independence and overall quality of life, making it difficult to perform simple tasks and enjoy previously routine activities. Compensation may address these life-altering impacts.
• Punitive Damages: In cases where negligence or failure to warn is proven, punitive damages may be awarded to penalize the drug manufacturer and prevent similar issues in the future.

A Beovu lawsuit can provide much-needed financial relief to those coping with lasting side effects and hold Novartis accountable for inadequate warnings regarding Beovu’s risks.

Next Steps for Those Affected by Beovu

Those who have experienced vision problems after Beovu treatment should:

• Seek immediate medical attention for any vision changes
• Document all symptoms and their progression
• Keep records of all medical appointments and treatments
• Maintain copies of medical records related to Beovu treatment
• Consider consulting with a qualified legal professional

If you or a loved one has experienced severe side effects following a Beovu injection, seeking legal guidance can help you determine your options. A lawyer who handles product liability cases can assist with gathering medical documentation, assessing damages, and filing a lawsuit if appropriate.

Connect with a Trusted Lawyer from Lawsuits.com 

For those seeking legal representation, navigating mass tort and product liability cases alone can feel overwhelming. At Lawsuits.com, our network of experienced local lawyers offers access to the trusted legal support necessary to build a strong case. Whether you’re coping with vision loss, retinal vasculitis, or other side effects from Beovu, Lawsuits.com connects you to a local attorney who can help.

Your lawyer will evaluate the specifics of your case, review your medical records, and advise on the best approach to seek compensation for your injuries. From case evaluations to filing claims, a local lawyer in your jurisdiction is ready to guide you through every step. 

Lawsuits.com aims to provide information and resources so that individuals affected by harmful medications like Beovu have access to the justice they deserve. Contact Lawsuits.com today at (888) 984-6195 or through the online form for a free consultation with an experienced local lawyer.