Beovu Side Effects
Beovu is a medication used to treat certain eye conditions. The original Beovu drug label failed to warn of some potentially severe side effects, including retinal damage and blindness.
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Common Side Effects of Beovu
Beovu, the brand name for brolucizumab-dbll, can cause mild to severe side effects. Beovu is injected into the eye by a health care provider to treat wet age-related macular degeneration and diabetic macular edema. Temporary vision changes may occur after receiving Beovu. Do not drive a car or operate machinery after receiving a Beovu injection.
- Blurred vision
- Development of cataract
- Bleeding in or around the eye
- Eye pain, redness or light sensitivity
- Seeing “floaters” or small specks
- Swelling of the eye or eyelid
It’s important to contact your doctor immediately if you experience any side effects or have any questions or concerns about taking Beovu.
Beovu is used to treat wet age-related macular degeneration and diabetic macular edema. These conditions can cause vision loss and make driving, reading or performing other activities more difficult. It also stops the growth of abnormal blood vessels and leakage in the eyes.
Serious Side Effects of Beovu
Beovu may cause serious side effects, including blood clots that can form in major arteries. A blood clot that develops in an artery can stop blood flow to the heart or brain, causing a fatal heart attack or stroke. Beovu may also damage the eyes and cause blindness. Additional side effects are listed below.
- Arterial Thromboembolic Events: This condition occurs when blood clots form in the arteries. A blood clot that cuts off blood flow to a major organ can cause severe damage or death.
- Endophthalmitis: This is a serious infection of the fluids or tissue in the eyeball and may cause blindness if not treated.
- Immunogenicity: Beovu contains components that can cause immunogenicity, an immune response that can make the body react in unhealthy or damaging ways.
- Retinal Detachment: Detachment occurs when a layer of tissue called the retina detaches from the back of the eye.
- Retinal Vascular Occlusion: This occurs when the small veins carrying blood away from the retina become blocked.
- Retinal Vasculitis: Inflammation of retinal blood vessel walls occurs in this condition.
Beovu contains a protein that may trigger an immune response, also known as immunogenicity. This response may cause eye inflammation, retinal vascular occlusion or retinal vasculitis. If you have questions or concerns about side effects, ask your doctor or pharmacist before taking Beovu.
FDA Approves Beovu Label Update With Safety Information
The current safety label for Beovu includes new information about the risk of retinal vascular occlusion and retinal vasculitis. These conditions may lead to eye damage and vision loss. In early 2020, Novartis received reports of severe Beovu side effects from the American Society of Retina Specialists. The ASRS reported these incidents to the U.S. Food and Drug Administration, prompting an investigation into Beovu.
Incidents of retinal vascular occlusion and retinal vasculitis appeared in human trials before and after the drug became available. On April 8, 2020, Novartis announced the conclusion of a safety review of post-marketing cases. This review included an external, independent Safety Review Committee.
Before the label update, some people who received Beovu injections experienced cases of retinal vascular occlusion or retinal vasculitis. Novartis, however, failed to warn health care providers of this risk. Some who received injections before the new warning label have filed Beovu lawsuits against Novartis, claiming the company had reports of retinal vascular occlusion and retinal vasculitis risks but did not warn the public. Beovu users have filed lawsuits against Novartis in all 50 states.
Other medications may cause retinal damage and vision changes as well, such as Elmiron, a drug used to treat some bladder conditions. This side effect is listed in the medication guide for Elmiron.
Who Should Not Take Beovu?
Beovu is contraindicated for some people, including people who have ocular infections, active ocular inflammation, or are allergic to Beovu.
While there’s a lack of human studies of Beovu administration in pregnant or breastfeeding women, Novartis recommends using Beovu only if the potential benefit outweighs the potential risk to the fetus. Animal trials uncovered potential risks to fetuses. Individuals who become pregnant while receiving Beovu treatment should contact their doctor right away.
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