Beovu lawsuits claim the drug’s manufacturer failed to warn patients and doctors about potential vision side effects. People who took Beovu and suffered vision loss, retinal vasculitis, occlusive retinal vasculitis and other vision problems may qualify to file a lawsuit for compensation.
Beovu (brolucizumab-dbll) is a prescription medication approved by the U.S. Food and Drug Administration to treat wet age-related macular degeneration (AMD). It’s administered by injection into the eye.
From its approval in October 2019 to February 2020, doctors have administered about 46,000 Beovu injections, Novartis told Healio.
In February 2020, the American Society of Retina Specialists (ASRS) shared an update with its members about reports of 14 cases of vasculitis in patients who took Beovu, according to Novartis’ statement to Healio. Vasculitis is inflammation of the vascular branches of arteries in the retina.
Of those 14 cases, 11 people suffered occlusive retinal vasculitis. Occlusive retinal vasculitis is a condition that happens when blood vessels in the eye become blocked. The condition may lead to blindness.
After a month, cases increased to 25 cases of retinal vasculitis. Twenty-one of them involved occlusion.
There were no warnings about these specific adverse events on the drug’s prescribing information until June 2020. Lawyers say Novartis put people at risk of vasculitis, occlusive retinal vasculitis and blindness by not warning them.
Novartis stands by Beovu’s safety and efficacy. In a June 2020 statement, the company said these reports are “rare post-marketing safety events.”
Injuries in Lawsuits
Beovu’s prescribing insert lists several vision-related side effects of the drug. The most common are blurred vision, cataracts, eye hemorrhage and blood vessel inflammation in the back of the eye. The original prescribing label didn’t include warnings about retinal vasculitis and retinal occlusion.
After reviewing the information from American Society of Retina Specialists (ASRS), Novartis announced in April 2020 that it would evaluate reports of severe vision loss, retinal artery occlusion and/or vasculitis with Beovu.
The drug maker concluded that “there is a confirmed safety signal of rare adverse events of ‘retinal vasculitis and/or retinal vascular occlusion that may result in severe vision loss.’”
In February 2020, FDA approved Novartis’ label change to include “additional safety information regarding retinal vasculitis and retinal vascular occlusion.”
- Occlusive retinal vasculitis
- Retinal artery occlusion
- Retinal vasculitis
- Vision loss
Woman Has Retinal Vasculitis After Beovu
In August 2020, Dr. Srinivas Sai A. Kondapalli of Everett and Hurite Ophthalmic Association in Pittsburgh, Pennsylvania, reported on a case of a 77-year old woman who suffered acute visual acuity loss in her right eye after taking two doses of Beovu. JAMA Ophthalmology published the case report.
Doctors diagnosed the woman with retinal vasculitis. She had previously taken bevacizumab and aflibercept for wet age-related macular degeneration and did not have any eye inflammation with either drug.
Symptoms of Retinal Vasculitis
Retinal vasculitis is a condition that causes inflammation in the retina, the part of the eye that senses light and allows you to see. Potential causes include infectious disease, a neurological disorder or autoimmune disease.
Retinal vasculitis can be aggressive and recurrent. In uncontrolled disease, it can lead to severe vision loss. It progresses through stages.
If retinal vasculitis occurs with occlusion from a blockage in a vein, it can cause sudden blurring or vision loss. Some vision loss starts as a slight blur then gets worse over hours or days.
- Altered color vision
- Blurring of vision
- Floaters (spots or streaks in vision)
- Metamorphopsia (a defect that causes linear objects, like lines, to look rounded or curvy)
- Scotoma (partial loss of vision or a blind spot)
Will There Be a Recall?
So far, Novartis and the FDA haven’t mentioned a Beovu recall.
While the FDA approved Novartis’ label change, it did not issue a safety communication to the public or announce any regulatory actions.
Another drug involved in vision loss lawsuits is Elmiron. According to Elmiron lawsuits, the drug’s maker — Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. — failed to warn people that the medication could cause a rare disorder called retinal pigmentary maculopathy.
Like retinal vasculitis, retinal pigmentary maculopathy can cause permanent vision loss.
FDA hasn’t announced a recall for Elmiron or issued a safety announcement. Janssen added a warning for retinal pigmentary maculopathy in June 2020.
Please seek the advice of a medical professional before making health care decisions.