Up-to-Date Timeline for Beovu: Approved by FDA | Safety Alerts & Warnings | Drug Label Changes | Novartis Investigation
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This Beovu timeline sets forth the still-developing story about why Beovu lawsuits might be filed against Novartis, the manufacturer of Beovu, alleging this pharmaceutical drug company failed to adequately warn doctors and patients about Beovu side effects.
The points of interest included in this Beovu timeline are the discovery of Beovu side effects such as vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation, the announcement of Beovu drug safety warnings by FDA, and more. This timeline will be kept up to date as we learn more about this Beovu drug injury situation.
The information on this Beovu timeline web page is presented by the Law Offices of Thomas J. Lamb, P.A., for general information purposes only, and is not intended as a scientific authority or medical advice.
October 7, 2019 – Beovu Approved by the FDA
Beovu is approved by the FDA to treat wet age-related macular degeneration.
Source: FDA Letter
February 23, 2020 – ASRS issue a note about Beovu related cases of retinal vasculitis
Chicago-based American Society of Retinal Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis across 46,000 injections since Beovu’s launch.
March 2, 2020 – Novartis claims current prescribing information documents are sufficient in risk analysis
Novartis stated the current prescribing information document for its macular degeneration drug Beovu sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion.
April 9, 2020 – Beovu label change revisions begin
Novartis said it would work with the FDA, the European Medicines Agency (EMA), and other drug safety regulators around the world to issue a revised Beovu drug label with new warnings about Beovu vision-related side effects.
Primary Source: Eye drug side effects are real, Novartis confirms in new warning
June 9, 2020 – Beovu Label Change Approved by the FDA
In early June 2020, the FDA approved a label update for Beovu whereby Novartis will add warnings and safety information about retinal vasculitis and retinal vascular occlusion, which can lead to loss of vision.
Primary Sources: FDA Supplemental Approval Letter and Beovu Full Prescribing Information (Revised 6/2020)
August 4, 2020 – Novartis Spokesman Gives Status Update on Beovu Safety Issues
In this four-minute video, a Novartis vice president discusses the company’s current approach to address Beovu safety issues relating to the occurrence of retinal vasculitis or retinal vascular occlusion associated with Beovu treatments.
September 14, 2020 – Beovu EU Label Change
Novartis updated the EU label to include retinal vasculitis and/or retinal vascular occlusion under “Special warnings and precautions for use” and “Undesirable effect”. The label notes that patients developing these events should discontinue treatment and the events should be promptly managed.
November 14, 2020 – Novartis Identifies New Risk Factor for Those With Pre-Existing Conditions
In the review issued by Novartis, the main risk of experiencing vision-altering side effects such as retinal vasculitis and/or retinal vascular occlusion within the six months after the first administration of Beovu was prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu.
Primary Source: Novartis identifies possible risk factors for Beovu patients
Secondary Sources: Novartis Update on Patients Suffering from Retinal Vasculitis and/or Retinal Vascular Occlusion After Beovu Injections and Pre-existing Eye Conditions Linked to Beovu-related Adverse Events
(Last Updated: 1/4/2021)
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