Christina Spicer  |  August 5, 2021

Category: Legal News

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Novartis Beovu now comes with added safety info.

The U.S. Food and Drug Administration (FDA) has approved adding safety information to the Novartis Beovu label, after instances of eye inflammation and vision loss were reported as possible Beovu side effects.

Novartis Beovu (generic name vrolucizumab) is an injection treatment for wet age-related macular degeneration (AMD), a chronic eye disorder.

Beovu was initially linked with a number of potential side effects during drug trials, including:

  • Blurred vision
  • Cataracts
  • Eye pain
  • Subconjunctival hemorrhages (broken blood vessels beneath the eye’s surface)
  • Vitreous “floaters” in the vision

The initial Novartis Beovu FDA approval for treating wet age-related macular degeneration was granted on October 8, 2019. However, not even a year after Beovu’s initial FDA approval, the agency approved a label update to add a new subsection in its warnings and precautions section about the risk of retinal vasculitis and/or retinal vascular occlusion.

Retinal vasculitis is inflammation of the retina’s tiny blood vessels and can vary drastically in severity. This kind of retinal blood vessel damage can lead to minimal, partial, or in some cases even complete blindness.

Retinal vascular occlusion is a condition in which the small veins responsible for carrying blood away from the retina are blocked with a buildup of blood or other fluids. This can prevent the retina from being able to properly filter light and can cause eye problems like sudden blurred vision or vision loss.

These conditions and other serious eye issues can be best treated if detected early. Making sure to have regular eye exams helps, as well as paying attention to your vision for symptoms such as blurriness, light flashes, sensitivity to light, difficulty reading, and more.

The Novartis Beovu label update came after the company had been alerted to some Beovu safety concerns. Novartis received postmarketing reports of retinal vasculitis and retinal vascular occlusion in 14 patients who had received the drug, per a news release from the company.

The addition to the Novartis Beovu label came after Novartis conducted an internal review beginning in early 2020.

Novartis agreed to update the drug’s label but stands behind Beovu’s safety and efficacy.

Novartis Beovu now comes with added safety info.“This label update provides clinicians with important information to guide treatment decisions. We believe Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile,” said Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer, Novartis Pharmaceuticals. “We remain grateful to all doctors who have taken the time to share their expertise and treatment experience to contribute to the collective understanding of these safety events. As we proceed to examine root causes and potential mitigation strategies, we will continue to communicate findings with transparency and urgency to regulatory bodies and healthcare providers.”

Research into these potential risk factors continues as a team of research, drug development, and medical specialists work with top global experts to study the causes of these issues and potential risk factors, as well as determine mitigation strategies and treatment recommendations.

“This broad-based coalition, which includes clinical trialists, epidemiologists, immunologists and uveitis specialists, is exploring innovative approaches to analyzing every aspect of available data, with the goal of providing physicians tools and information to safely and confidently treat their patients with Beovu,” said Dr. Jeff Heier, Co-President and Medical Director, Director of the Vitreoretinal Service, and Director of Retina Research at Ophthalmic Consultants of Boston, Chair of the Safety Review Committee and a member of the coalition.

Why Were Novartis Beovu Risks Discovered After FDA Approval?

Though the company has agreed to update the Novartis Beovu safety label, questions remain about how the risks of the drug were missed before it was approved by the Food and Drug Administration. Specifically, how was a vision treatment that carried a risk of severe vision loss allowed on the market in the first place?

According to Healio News, there are a number of ways medical devices and drugs can make be approved without the manufacturer discovering or disclosing their risks, including:

  • Insufficient funding for research
  • Commitment bias
  • Poor research trial design
  • Failure to research the right risks
  • Failure to meet agency standards
  • Agency bias
  • The company conceals research results
  • Plain bad luck

Experts told Healio that Beovu treatment resulted in a high than expected rate of retinal vasculitis, indicating that these drug trials should include additional measures to account for pathology in the peripheral retina. While it is commendable that Novartis updated its safety information in light of patient reports and additional research after the drug was approved, patients were still exposed to additional risks.

According to Healio, investigations into Beovu’s risks continue, with Novartis funding an investigation through a Safety Review Committee. In addition, the American Society of Retina Specialists is also conducting research into Beaovu. However, the drug is still available to patients, albeit as a secondary therapy to safer drugs that were reportedly on the market at the time of Beovu’s approval.

Filing a Novartis Beovu Lawsuit

Because of the new label change, doctors prescribing Beovu and patients considering taking the drug will now be aware of these risks. However, patients who were prescribed Beovu between its introduction to the market in Oct. 2019 and the recent addition of these warnings may not have been adequately warned about these risks. Affected patients may be able to file a lawsuit against Novartis for failing to warn them about these risks.

Some Beovu patients already took legal action against Novartis. In Nebraska, one woman filed a lawsuit alleging that she developed serious eye problems including retinal artery occlusion. As a result, the plaintiff allegedly experienced pain and suffering, permanent disability, and financial injuries.

According to the Beovu lawsuit, the plaintiff would not have been treated with the wet AMD injection if she and her doctor had been sufficiently warned of the risks for eye injury.

If you have suffered from any of the below eye problems after taking Novartis Beovu, you may be able to file or join a Beovu side effects class action lawsuit.

  • Retinal vasculitis
  • Retinal vascular (vein) occlusion
  • Vision loss
  • Blindness
  • Other vision problems

Filing a lawsuit can be a daunting prospect, especially while already dealing with medical issues like vision problems. Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

Free Beovu Vision Loss & Blindness Lawsuit Investigation Evaluation

If you suffered from any of the listed eye problems after taking Beovu, you may be eligible to join this Beovu side effects lawsuit investigation.

Some symptoms include:

  • Retinal vasculitis
  • Retinal vascular (vein) occlusion
  • Vision loss
  • Blindness

… or other vision problems.

Fill out the form on this page for a FREE case evaluation.

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Free Beovu Vision Loss & Blindness Lawsuit Investigation Evaluation

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