At Issue Is Dangerous Form Of Eye Inflammation, Occlusive Retinal Vasculitis, Which Can Lead To Vision Loss Or Blindness
On March 2, 2020 Novartis stated that the current Prescribing Information document for its macular degeneration drug Beovu sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion. This Novartis statement about a recent Beovu safety issue is in response to a notification for eye doctors issued last week by the American Society of Retina Specialists about 11 case reports of Beovu-associated occlusive retinal vasculitis, which can lead to vision loss or blindness.
To set the stage for this contention by Novartis about the Beovu package insert, or drug label, you may want to see our previous article about this emerging safety issue, "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug".
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As regards this recent Novartis statement about Beovu safety, we get the following information from a March 2, 2020 Fierce Pharma news report, "Novartis stands behind Beovu's safety, benefits after vision-loss warning":
“We believe the incidence of these events remains consistent with or below the package insert,” [Novartis] said in its [March 2, 2020 statement].
Most of the cases have started after patients’ first or second injection of the wet age-related macular degeneration (AMD) drug, Novartis said. The company has instructed doctors to advise patients to seek care immediately if they experience redness in the eye, light sensitivity, pain or changes in vision. The drug also shouldn’t be used in patients with intraoccular inflammation.
Aside from its own review, the company is working with its data monitoring committee for ongoing global trials of Beovu, and it's brought in an external review group to look at the cases. Drug authorities in the U.S., Europe, Switzerland and Australia know about the review, and Novartis said it’s getting in touch with other regulators.
Of course, we will continue to monitor this emerging Beovu safety issue and report significant developments here on Drug Injury Watch.
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