Retinal Vasculitis and Retinal Vascular Occlusion to be Added to Beovu Label
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
After a recent external safety committee review of Beovu, several adverse side effects of the drug were found that may lead to severe vision loss. The FDA recently approved a label change for Beovu to include "Retinal Vasculitis and/or Retinal Vascular Occlusion" to the Warnings and Precautions section of the Prescribing Information for Beovu.
Recent Adverse Side Effects of Beovu Confirmed
Since Beovu's approval by the FDA in October 2019, Novartis has received 14 reports of vasculitis occurring in patients who received the drug for treatment of wet age-related macular degeneration. Novartis, the manufacturing company for Beovu, confirmed a safety signal of rare adverse events including retinal vasculitis and retinal vascular occlusion. Both retinal vasculitis and retinal vascular occlusion can lead to severe vision loss.
The adverse events typically occurred in patients who showed signs of intraocular inflammation. Physicians are being advised to look for signs of intraocular inflammation before injecting Beovu, and should not administer the drug if signs of intraocular inflammation are present, according to a press release by Novartis.
Novartis' Findings on Adverse Side Effects
According to a June 2020 article written for Ocular Surgery News, the cases of Beovu-related retinal vasculitis and retinal vascular occlusion are rare:
According to post-marketing data, retinal vasculitis, retinal vascular occlusion or retinal vasculitis plus retinal vascular occlusion were evident in every 6.99 per 10,000 injections. Retinal vasculitis was evident in 1.69 per 10,000 injections, retinal vascular occlusion was evident in 1.57 per 10,000 injections, and retinal vasculitis plus retinal vascular occlusion was evident in 3.73 per 10,000 injections.
However, both retinal vasculitis and retinal vascular occlusion can lead to severe vision loss and even blindness.
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Label Change Expected
According to a June 11, 2020, Press Release by Novartis, the company is currently working with the FDA to make label changes and updates to the prescribing information for the drug:
Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Beovu (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion.
A recent Beovu Label Change Approval Letter released by the FDA on June 9, 2020, notes the changes that are to be expected in the coming weeks:
This Prior Approval supplemental biologics application provides for the addition of “Retinal Vasculitis and/or Retinal Vascular Occlusion” to the Warnings and Precautions section of the Prescribing Information.
For a complete list of side effects or more information on Beovu, please visit our Beovu Drug Information Page.
We will continue to monitor the issues surrounding Beovu and provide you with any new or relevant information. Please feel free to share any information with us as well.
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