Law Offices of Thomas J. Lamb

  • Asbestos & Mesothelioma
  • Benzene Diseases
  • Drug Injury
  • About Our Firm
  • Free Case Evaluation
  • Frequently Asked Questions

Beovu: External Safety Review Committee Findings Lead To New Vision-Related Side Effects Warnings

July 9, 2020 By Law Offices of Thomas J. Lamb, P.A.

First, Novartis set up an internal review of Beovu vision-related side effects observed in the HAWK & HARRIER clinical trials, including rare post-marketing safety reports of vasculitis. In turn, new warnings for Beovu eye injections about retinal vasculitis and retinal vascular occlusion were added to the Beovu drug label. We take a closer look at these Beovu safety developments in this article.

We begin with this June 9, 2020, Ocular Surgery News report, “Review committee confirms safety signal of rare adverse events for Beovu”, from which we get these insights:

Novartis received reports of vasculitis in 14 patients treated for wet age-related macular degeneration with Beovu (brolucizumab-dbll) since its approval by the FDA in October 2019. The company initiated an internal review of the case reports and established an external safety review committee (SRC) to provide an independent review of the cases….

The SRC compared the reported cases with events seen in the [Beovu] phase 3 HAWK and HARRIER trials. Using terminology defined by the SRC, Novartis confirmed a safety signal of rare adverse events termed as “retinal vasculitis” and/or “retinal vascular occlusion,” which typically occurred in the presence of intraocular inflammation. The adverse events may lead to severe vision loss…

In connection with these post-marketing reports of Beovu vision-related side effects, on June 9, 2020, the FDA approved a Beovu drug label change which added warnings about retinal vasculitis and retinal vascular occlusion, which can lead to loss of vision. Following this FDA regulatory action, there have been new Beovu warnings added in Australia and Switzerland, with more drug safety regulatory actions expected in other countries going forward.

We are currently investigating drug injury lawsuits against Novartis for Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.

[View article at original source]

Beovu

Free Case Evaluation

Strictly Confidential, No Obligation

Filed Under: Unsafe Drugs Tagged With: Beovu, blindness, intraocular inflammation, occlusive retinal vasculitis, retinal vascular occlusion, retinal vasculitis, vision loss

Find What You Want Here

Get Free Case Evaluation

We encourage you to submit an online Case Evaluation Form form – it is confidential and there is no obligation.

Or call our toll-free number, 800-426-9535, to speak directly to attorney Tom Lamb about your possible case.

Feel Free To Contact Us

Quick Contact Form
 
Send an Email to Tom Lamb

(800) 426-9535

Main Navigation Menu

  • About Our Firm
  • Asbestos-Mesothelioma Cases
  • Benzene Disease Claims
  • Drug Injury Cases
  • Breast Implant Cases
  • Philips Breathing Devices Cases
  • GenX Cancer Cases
  • Case Evaluation Menu
  • Quick Contact Form
  • Frequently Asked Questions
  • Medical Records Charges
  • Collection of Articles
  • Sitemap

Lamb Law Office Newsletter

Lamb Law Office Newsletter provides periodic updates about some of the cases that we are working on for clients, as well as an information resource you might find helpful.

Subscribe using Form below.

Subscription Form

* indicates required

Our Other Websites

Drug Injury Law
Drug Injury Watch
Drug Safety Developments
Asbestos & Mesothelioma

Contact Information

Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com

  • Home
  • Frequently Asked Questions
  • Disclaimer and Copyright Notices

Copyright © 2022 · Law Offices of Thomas J. Lamb, P.A.