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Law Offices of Thomas J. Lamb

Beovu Label Change: Novartis Adds Information, Increases Safety Warnings in February 2022

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We had been watching for a second Beovu label change since May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, and, at the same time, said it would update the Beovu drug label. Finally, in February 2022, Novartis added information and increased safety warnings about various Beovu side effects, such as retinal vasculitis, retinal vascular occlusion, and retinal artery occlusion.  The first Beovu label change happened back in June 2020.

So that people can draw their own conclusions about what this February 2022 Beovu label change means as regards the lingering Beovu safety issues mentioned at the outset, and to be able to compare the Beovu Prescribing Information “Revised: 2/2022” document with the earlier “Revised: 6/2020” version, we direct you to this FDA webpage “Drug Safety-related Labeling Changes (SrLC) for Beovu (brolucizumab-dbll)“.

There you will see the extent of revisions made to the three parts that are  identified in the “Recent Major Changes” section of the new 2022 Beovu drug label:

  • 5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion
  • 6.1 Clinical Trials Experience
  • 6.2 Immunogenicity

As background, Beovu was approved by the FDA in 2019 as a treatment for neovascular (wet) age-related macular degeneration (AMD). Since then, there have been reported cases of Beovu eye-related side effects such as retinal vasculitis, retinal vascular occlusion, or retinal artery occlusion leading to vision loss. We have followed these Beovu safety issues for the past two years, and we will continue to watch for further developments concerning Beovu eye-related side effects such as retinal vasculitis, retinal vascular occlusion, and retinal artery occlusion.

As we have reported previously, starting in January 2021, Beovu lawsuits have been filed for patients alleging that Novartis failed to warn doctors and patients about these Beovu vision loss side effects in a timely manner.  As mentioned at the outset, there was a first Beovu label change in June 2020 and, now, a second Beovu label change in February 2022.

We continue to investigate Beovu drug injury lawsuits against Novartis where there has been vision loss due to retinal vasculitis, retinal vascular occlusion, or retinal artery occlusion after patients received their Beovu injections.

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Beovu Drug Label Revised December 2021 Was Issued in Europe, But Not in the US

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A “new” Beovu drug label which was revised in December 2021 sets forth some additional information about the vision-related Beovu side effects intraocular inflammation, retinal vasculitis, and retinal vascular occlusion. We point out, however, that there was no similar 2021 Beovu label change issued by Novartis in the US.

From this Drug Safety Update, “Brolucizumab (Beovu▼): risk of intraocular inflammation and retinal vascular occlusion increased with short dosing intervals”, issued January 18, 2022, by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), we get the following:

New information on [the Beovu adverse events retinal vasculitis and retinal vascular occlusion], including risk factors and possible mechanism, was considered in a recent European safety review and ophthalmologists were informed of the new recommendations in a letter in November 2021. The product information of [Beovu (brolucizumab)] will also be updated to reflect this information.

In the so-called “Dear Doctor” letter about Beovu that Novartis UK sent on November 2, 2021, to healthcare professionals in the UK there are these two important sections:

  1. “Risk factors identified”; and,
  2. “Immune‐mediated event”.

We expect that a similar Beovu drug label change, and a possible associated Beovu “Dear Doctor” letter, will be issued by Novartis here in the US soon.

Be assured we will continue to monitor the drug safety regulatory sector for further developments regarding Beovu vision loss side effects such as intraocular inflammation, retinal vasculitis, and retinal vascular occlusion.

For more information about Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation, see our Beovu Side Effects page on our DrugInjuryLaw.com website.

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Beovu: Rates of Intraocular Inflammation and Retinal Vascular Occlusion

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A November 2021 article published by the medical journal JAMA Ophthalmology, “Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration”, provides new information about the incidence rates of intraocular inflammation and retinal vascular occlusion associated with Beovu (brolucizumab). This is our 19th article about Beovu safety developments since February 2020, when the various vision loss Beovu safety issues first came on our radar.

From the Abstract for this November 2021 JAMA Ophthalmology article, we point out these selected parts:

  • Importance: Limited data exist on the real-world safety outcomes of patients with neovascular age-related macular degeneration treated with brolucizumab (Beovu).
  • Objective: To determine the real-world incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and/or retinal vascular occlusion (RO), for patients with neovascular age-related macular degeneration who underwent [Beovu (brolucizumab)] treatment. Additionally, potential risk factors associated with these adverse events were evaluated.
  • Conclusions and Relevance: The incidence rate of IOI and/or RO was approximately 2.4%. Patient eyes with IOI and/or RO in the 12 months prior to first [Beovu (brolucizumab)] injection had the highest observed risk rate for IOI and/or RO in the early months after the first [Beovu (brolucizumab)] treatment. However, given study limitations, the identified risk factors cannot be used as predictors of IOI and/or RO events, and causality with [Beovu (brolucizumab)] cannot be assessed.

There was also an Invited Commentary piece related to the above medical journal article which was also published by the medical journal JAMA Ophthalmology titled “Risk Factors for Intraocular Inflammation After Brolucizumab Treatment”, fromw which we get this guidance for ophthalmologists that use Beovu for their AMD patients:

Clinicians should maintain heightened awareness for RO and/or RV with IOI after [Beovu (brolucizumab)] and be familiar with diagnostic imaging protocols especially widefield fluorescein angiography and recommended treatment algorithms. Based on the current literature, same-day bilateral [Beovu (brolucizumab)] injections should be avoided and [Beovu (brolucizumab)] is contraindicated in eyes with active IOI or a history of IOI related to [Beovu (brolucizumab)]. Based on the study from Khanani and colleagues, a recent history of IOI and/or RO should be considered as another potential risk factor for [Beovu (brolucizumab)]-related IOI.

We will continue to monitor the medical journals for Beovu safety developments and, in particular, intraocular inflammation and retinal vascular occlusion associated with Beovu.

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Drug Injury Lawsuits: List of Some Cases Filed in First Half of 2021

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A drug injury lawsuit is a personal injury case or a wrongful death case involving a serious drug side effect or a severe adverse drug reaction.

Here are some of the prescription medications for which drug injury lawsuits were filed against the responsible pharmaceutical company in the first half of 2021:

  • Xeljanz
  • Beovu
  • Elmiron
  • Injectafer
  • Belviq
  • Ocaliva
  • Uloric
  • Invokana / Farxiga / Jardiance
  • Tasigna
  • Actemra

The best way to make a claim for legal compensation for an injury or death caused by a serious drug side effect or a severe adverse drug reaction is by filing an individual drug injury lawsuit (not a class action).

It is important to know that each state has a statute of limitations that determines the time period within which one may file a drug injury lawsuit. For example, in some states a personal injury claim must be filed within 1 or 2 years from the date that the serious drug side effect or the severe adverse drug reaction is diagnosed. Likewise, some states require that a wrongful death claim be filed within 1 or 2 years from the date of a death which was caused by a serious drug side effect or a severe adverse drug reaction. Be aware that these statutes of limitations, or deadlines, vary from state to state.

Because of these strict filing deadlines, you should not delay in finding an experienced drug injury lawyer when you may have a possible case involving a serious drug side effect or a severe adverse drug reaction.

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Novartis Stops 3 Beovu Clinical Trials in May 2021, Wants a Beovu Label Change

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In late May 2021, the latest study data concerning Beovu safety issues resulted in Novartis stopping three key clinical trials — MERLIN, RAPTOR, and RAVEN — as well as Novartis indicating there will be another Beovu label change.

To see how Novartis is seeking to present the current status of its lingering Beovu safety issues as well as the next Beovu label change take a look at their May 28, 2021, Media Release item, “Novartis reports one year results of Phase III MERLIN study evaluating Beovu® every four week dosing and provides update on Beovu clinical program“, which includes this statement:

Novartis has proactively communicated these data to health authorities and will pursue an update to the Beovu prescribing information globally.

We are watching for this forecasted Beovu label change which will, presumably, add new and updated warnings about Beovu vision loss side effects.

For a more in-depth view of this latest development as regards Beovu safety issues, we turn to this June 1, 2021, FiercePharma news report, “Novartis calls off 3 Beovu trials testing more frequent dosing on concerns of vision-threatening side effect”:

[In the MERLIN clinical trial] Beovu doubled the rate of intraocular inflammation compared with [Eylea], with 9.3% percent of patients suffering the complication in the Beovu trial arm. That compared with 4.5% for Eylea. None of the Eylea patients developed reginal vasculitis or retinal vascular occlusion, while those side effects happened in 0.8% and 2% of Beovu patients, respectively. The problem could potentially damage a person’s vision.

In Merlin, the rate of vision loss from any cause was 4.8% for Beovu patients and 1.7% for Eylea patients….

The company has yet to identify the root cause behind Beovu’s safety problem.

As we have reported previously, Beovu lawsuits for our clients have been filed starting in January 2021, alleging Novartis failed to warn doctors and patients about these Beovu safety issues. Our law firm began investigating drug injury lawsuits against Novartis for Beovu back in February 2020, and we continue to accept Beovu cases that involve vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.

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Beovu Lawsuits are Filed As Individual Cases; 3 Reasons to Contact Us

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We want to clear up some possible confusion. If a patient has vision loss or blindness after getting Beovu injections in their eyes, this person must contact a lawyer or law firm to handle their Beovu case in order to get legal compensation for the Beovu drug injury they have suffered. That is because Beovu vision loss lawsuits are being filed as individual cases and there will not be any Beovu class actions for people who have experienced Beovu eye problems.

Here are 3 reasons why a person with a possible Beovu vision loss lawsuit might want to select our law firm for handling their Beovu lawsuit against Novartis.

(1) We started investigating these Beovu eye problems soon after the American Society of Retinal Specialists (ASRS) issued a Beovu drug safety alert to its members in February 2020. In fact, our February 27, 2020 article, “Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug“, was one of the first articles written about these Beovu eye problems.

(2) Since then we have closely monitored this Beovu drug safety issue and written many more articles about the circumstances surrounding case reports of loss and blindness following Beovu injections.  Generally, those patients were diagnosed with one or more of these eye problems:

• Retinal Vasculitis
• Occlusive Retinal Vasculitis
• Retinal Artery Occlusion
• Retinal Vascular Occlusion

(3) The first three Beovu vision loss lawsuits filed in the US were for clients of our law firm. Each of those three women had their Beovu lawsuit filed as an individual case. The basic liability allegations in those Beovu lawsuits, as well as other Beovu cases concerning Beovu eye problems, are:

  • Novartis misrepresented that Beovu was a safe treatment for age-related macular degeneration; and,
  • Novartis failed to warn about Beovu eye injection reactions causing vision loss and blindness.

If we can be of assistance to you or someone else regarding a possible Beovu lawsuit for vision loss or blindness due to Beovu eye injection reactions, you can submit a Beovu Case Evaluation Form online or you can call us on our toll-free number: 800-426-9535.

Again, we point out the important fact that these Beovu vision loss lawsuits are filed as individual cases. There will not be any Beovu class actions for Beovu eye problems. As such, people with Beovu eye injection reactions must contact a lawyer or law firm to have their Beovu lawsuit filed so they can get legal compensation from Novartis for their Beovu drug injury.

We respectfully suggest those people should contact our law firm for the 3 reasons set forth above.

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Beovu Side Effects and Beovu Lawsuits for Patients Complicate Future for Beovu

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Given the serious nature and number of Beovu side effects reported to date, together with the Beovu lawsuits filed against Novartis for patients with severe vision loss, it seems fair to say that things look a bit grim for Beovu and Novartis at the start of 2021. So what does the path forward look like for Beovu?

Let’s start with where things stand today:

  • Like Eylea and Lucentis, Beovu injections are used for treatment of neovascular (wet) age-related macular degeneration (AMD).
  • However, Beovu side effects such as occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation have resulted in vision loss and blindness.
  • Starting in January 2021 Beovu lawsuits have been filed for patients alleging Novartis failed to adequately warn about these serious Beovu side effects.
  • Given this situation, some eye doctors are avoiding Beovu when treating their AMD patients.

A possible indication of the Novartis strategy for battling back from this less-than-ideal current posture can be found in a “Novartis Fourth Quarter and Full Year 2020 Condensed financial report – Supplementary Data” document:

Post marketing cases termed as “intraocular inflammation.” and/or “retinal vascular occlusion” that may result in severe vision loss, typically associated with intraocular inflammation and the current COVID-19 situation had an unfavorable impact on sales. Novartis has a comprehensive plan, in strong collaboration with leading external global experts to educate the retina community about the positive benefit / risk profile of Beovu.

It seems that this Novartis plan to get Beovu back on the path of being a so-called “blockbuster” drug for Novartis in terms of sales might involve its external safety review committee (SRC). In the past, Novartis has implied that this panel of experts was set up to provide an independent review of the Beovu side effects case reports.

Our law firm is investigating possible Beovu lawsuits for patients who have suffered vision loss or blindness due to Beovu side effects. If we can be of assistance to you or someone else regarding a Beovu drug injury case, you can submit a Case Evaluation Form online or you can call us on our toll-free number: 800-426-9535.

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Beovu: What Comes Next for This Troubled Novartis AMD Eye Injection?

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As we start 2021, let’s look at where things currently stand with the Beovu “safety issue” — Beovu adverse drug reactions and Beovu-related eye problems — and how we got here. In the 15 months since Beovu was approved by the FDA in October 2019, there have been numerous reports of Beovu causing occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation, often leading to vision loss and blindness.

In November 2020 Novartis said that patients with prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu. See “Novartis Update on Patients Suffering from Retinal Vasculitis and/or Retinal Vascular Occlusion After Beovu Injections“.

Two months earlier, in September 2020, stronger warnings about retinal vasculitis and/or retinal vascular occlusion were put in the Beovu drug label used in Europe. See “Safety of Beovu: A Lingering Issue Which Novartis Attempts to Counter with Recent Study Results“.

That happened three months after there was a Beovu label change here in the US. See “Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020“.

It was back in April 2020 that Novartis said it would work with drug safety regulators around the world to issue revised Beovu drug labels with new warnings about Beovu vision-related side effects. See “Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report“.

But only a month before that, in March 2020, Novartis had asserted that its original (and then current) Beovu drug labels in the US and Europe were already had sufficient warnings about the Beovu adverse drug reactions and Beovu-related eye problems associated with its (then) relatively new age-related macular degeneration (AMD) drug. See “Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings“.

And this Beovu “safety issue” all started in February 2020, when the American Society of Retinal Specialists (ASRS) issued an alert to members about 14 cases of retinal vasculitis associated with Beovu injections. See “Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug“.

So, what might happen in 2021 as regards these Beovu adverse drug reactions and Beovu-related eye problems? One thing we are anxiously waiting for is more information to be released by Novartis about the findings of their panel of experts who are considering this Beovu safety issue.

Our law firm is investigating possible Beovu lawsuits for patients who have been diagnosed with vision loss, blindness, or other serious eye problems which are Beovu side effects.  Please feel free to send an email to Tom Lamb if we can be of assistance to you or someone else regarding a Beovu drug injury case. Or you can call us on our toll-free number: 800-426-9535.

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Beovu-related Retinal Vasculitis and Beovu Vision Loss Cases

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As of December 2020, the investigation continues to find the root causes of Beovu-related retinal vasculitis which seems to be involved in many of the growing numbers of Beovu vision loss cases. At the same time retina specialists and other eye doctors are still trying to determine the best medical management or treatment methods for Beovu patients with occlusive retinal vasculitis resulting in vision loss.

Here are two recent medical journal articles relevant to Beovu-related retinal vasculitis and Beovu vision loss cases:

“Risk of inflammation, retinal vasculitis and retinal occlusion-related events with brolucizumab: post-hoc review of HAWK and HARRIER”, published November 15, 2020, by the medical journal Ophthalmology; and,

“Expert Opinion on Management of Intraocular Inflammation, Retinal Vasculitis, and/or Vascular Occlusion after Brolucizumab Treatment”, published September 28, 2020, by the medical journal Ophthalmology Retina.

Starting back in February 2020, our law firm has been investigating Beovu vision loss cases for patients who have been diagnosed with Beovu-related retinal vasculitis or other potentially life-changing potentially life-changing Beovu side effects.

If we can be of assistance to you or someone else regarding a Beovu vision loss case, you can submit a Beovu Case Evaluation Form online or you can call us on our toll-free number: 800-426-9535.

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Beovu Injections Side Effects: Novartis Points Out Risk Factors and Possible Causes in November 2020 Report

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In mid-November 2020 Novartis addressed the root causes and potential risk factors for Beovu patients developing vision loss by releasing some findings by its experts examining these adverse events associated with Beovu injections.

From this November 14, 2020, Reuters new report, “Novartis identifies possible risk factors for Beovu patients”, we get the latest information about eye side effects associated with Beovu injections:

According to Novartis’s review, among 12,000 patients treated with Beovu, the highest observed risk for experiencing retinal vasculitis and/or retinal vascular occlusion in the six months after first treatment was prior intraocular inflammation and/or vascular occlusion in the 12 months before the first Beovu injection.

The observed overall risk rate of 0.46% for all Beovu-treated patients increased to 3.97% in people who had the conditions before treatment, Novartis said.

To date, case reports of Beovu patients developing vision loss have established that:

  1. Retinal vasculitis and/or retinal vascular occlusion can occur as early as the first or second Beovu injections; and,
  2. Severe vision loss or other changes in vision within one to two weeks of the Beovu injections.

More information about Beovu patients developing vision loss is set forth in this article, “ReST committee provides update on brolucizumab”, published by Healio Ophthalmology on November 15, 2020:

The American Society of Retina Specialists Research and Safety in Therapeutics (ReST) committee began to receive reports of intraocular inflammation alone and retinal vasculitis in patients who underwent injections of Beovu (brolucizumab, Novartis) following its FDA approval for neovascular age-related macular degeneration in October 2019. To date, the committee has received 120 reports….

Through April 2020, the committee received reports of retinal vasculitis in 26 eyes of 25 patients. These patients showed a more precipitous loss of vision that did not recover, with 46% of eyes losing more than three lines of vision and 35% of eyes losing more than six lines of vision….

We are investigating possible Beovu drug injury lawsuits against Novartis for patients who suffered vision loss following their Beovu treatments.

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Law Offices of Thomas J. Lamb, P.A.
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