Has There Been a Beovu Recall?

There is no Beovu recall, but the FDA approved label changes regarding adverse eye problems in 2020 to better inform patients and doctors.

Beovu Eye Problems

Beovu (brolucizumab) is an eye injection used to treat wet age-related macular degeneration (AMD), an eye condition caused by leaking blood vessels in the eye. Symptoms of the condition include blurry vision and blind spots. If left untreated, wet AMD can cause severe vision loss.

Although patients aimed to prevent eye problems by agreeing to Beovu treatment, the drug may actually cause serious eye problems instead of fixing wet AMD vision loss.

Beovu is associated with various eye-related complications including retinal vasculitis and retinal vascular occlusion. Retinal vasculitis is the inflammation of blood vessels in the retina. Retinal vascular occlusion is a blockage of the same blood vessels in the retina. Both conditions can lead to vision disturbances and even permanent vision loss.

Has There Been a Beovu Recall?

There is no Beovu recall from Novartis or the U.S. Food and Drug Administration (FDA). However, the FDA approved safety label changes last year which better warn about the risks for adverse Beovu eye problems.

The updated label information includes specific information about the risks of retinal vasculitis and retinal vascular occlusion while taking Beovu.

“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,” Marcia Kayath, Novartis’ Global Head of Medical Affairs and Chief Medical Officer, said in a press release following the label change.

“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.”

Later in 2020, a Novartis safety review identified risk factors for Beovu eye problems, including previous intraocular inflammation or prior retinal vascular occlusion within 12 months of the first injection treatment.

While the risk rate for Beovu eye problems was 0.46% for all patients, people who suffered from the conditions listed above before treatment had a 3.97% risk rate for complications. Novartis changed Beovu’s safety profile and contraindications to reflect these risks.

In May 2021, after revealing one year results from a Phase III trial, Novartis prematurely ended two other safety trials due to the confirmation of Beovu’s link to eye inflammation and other problems. The trials aimed to explore more frequent dosing for Beovu patients and the safety and efficacy of more frequent doses. Other trials were continued, with Novartis reporting a “well-tolerated” safety profile.

Although the FDA has not announced a Beovu recall, the new label changes effectively warn both patients and doctors about the risks associated with the drug. However, while new Beovu patients may feel sufficiently warned about the risks, original patients may not have received the same forewarning.

Novartis faces lawsuits from consumers who claim that the company did not warn them about the potential of Beovu eye problems they suffered from after treatment. If you experienced these problems, you may be able to join other plaintiffs by taking legal action.