FDA Amends Label on Harmful Prescription Eye Injection
After initial approval in 2019, the U.S. Food and Drug Association released an amended label on the prescription injection drug Beovu to disclose the severe side effects it may cause. Released by the medical research center Novartis, Beovu is one of three drugs approved by the FDA that treats Wet AMD, a chronic eye disease. Since its release, Beovu has been found to have some extremely serious side effects undisclosed in their initial clinical trials. Patients are suing Novartis for their negligence and failure to acknowledge the severe risks of use.
What is Beovu?
Beovu, also known as brolucizumab-dbll, is a prescription injection into the eyeball to treat Wet AMD. Created by the medical research center, Novartis, it is administered every month for three months and then every 8-12 weeks.
Wet AMD is a chronic eye disorder that is the leading cause of visual impairment in elderly patients. It develops when abnormal blood vessels grow into the central area of the retina known as the macula. The subsequent leakage of blood or fluid causes scarring to this area which leads to an accelerated and severe loss of vision.
If caught early, Wet AMD can be treated or even reversed. Beovu works to prevent new blood vessels from being produced by blocking VEGF (vascular endothelial growth factor) which leads to fewer vessels and thus reduced fluid.
Why Is Beovu Dangerous?
Despite its FDA approval, Beovu was quickly put under scrutiny when users began showing severe side effects to the drug. In 2020, The American Society of Retina Specialists conducted a post-release case study on the side effects of this drug to assess Novartis’ claims of safety and lack of severe side effects. From this study, the ASRS uncovered some patients who experienced cases of vasculitis and/or mild to moderate intraocular inflammation which are extreme side effects. This called for immediate action.
Since the initial release and subsequent ASRS Study, the FDA has approved a new label for the drug. This new label and update informs doctors of the adverse reactions patients may have to using this drug, and advises patients of safety factors they should take into consideration prior to using this drug.
In addition to typical side effects of drugs that treat this disease, Beovu, while supposed to help reduce vision loss has the potential to cause complete blindness.
What To Do If You Have Used Beovu?
Since the release of this data, Novartis has claimed to be putting together a team to conduct their own research regarding the side effects of this drug. However, their blatant failure to thoroughly test their product prior to its release has had detrimental implications for some patients that cannot be reversed by new data. Novartis has made no indication that they plan on recalling this product, as they see the profits outweigh the implications on their users.
There are other, safer, medications on the market and should be prioritized by doctors.
Product Liability Lawyers Taking Beovu Cases
If you or a loved one believe you have been harmed by Beovu, contact our experienced product liability team to get the help you deserve. At Meyers & Flowers, our track record of large resolutions for victims of dangerous drugs is a testament to the representation you will receive. With no fees, unless we win, contact us today for a free case evaluation at (630) 232-6333, [email protected], or on our website.