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Gilenya Label Change with New Liver Injury Risk Warnings in Canada
In the final two months of 2020, we saw a Gilenya label change adding new liver risk warnings announced by drug regulators in Europe, first, and the United Kingdom (UK), later. Next, in January 2021, Health Canada posted a Gilenya drug safety alert about patients developing Gilenya-associated liver injury, including acute liver failure requiring a liver transplant.
This Health Canada Dear Healthcare Professional Letter, “GILENYA (fingolimod) – Risk of Liver Injury”, provided some background, as well as added information about this Gilenya drug safety issue:
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The most recent periodic review of international safety data identified cases of liver failure, some requiring liver transplant, in patients treated with GILENYA. Other cases of clinically significant liver injury were also reported in patients treated with GILENYA. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have appeared shortly following the initiation of treatment as well as after prolonged use.
In the US, the Gilenya drug label was revised back in November to add warnings about Gilenya-associated liver injury, including acute liver failure requiring a liver transplant. See 5 WARNINGS AND PRECAUTIONS, 5.5 Liver Injury.
We will watch to see whether the FDA mandates any further Gilenya label change with increased liver risk warnings here in the US going forward.
[Read article in full at original source]Elmiron Legal Cases for Eye Damage and Retinal Injury Are Consolidated in Elmiron MDL
In December 2020, all Elmiron legal cases alleging eye damage and retinal injury filed in the federal courts were consolidated by means of an Elmiron MDL Order. These Elmiron legal cases are noteworthy as regards the monetary damages aspect of a lawsuit because these Elmiron-related eye problems can lead to vision loss or blindness.
From the Transfer Order issued for In Re: Elmiron [Pentosan Polysulfate Sodium] Products Liability Litigation, MDL Docket No. 2973, we get the following legal information:
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After considering the argument of counsel, we find that centralization of these actions in the District of New Jersey will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The actions involve common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy. Several defendants have marketed Elmiron since its approval in 1996. This litigation likely will implicate complex scientific and regulatory issues. Centralization will eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary. [Footnote omitted.]
Unlike most pharmaceutical drug injury lawsuits, for these Elmiron legal cases a person does not need to have been using Elmiron at the time when their eye damage or retinal injury was diagnosed by a doctor. This is because there can be a delay, or latency period, from a patient’s Elimiron “exposure” until there is Elmirion “toxicity” causing eye damage and retinal injury.
If we can be of assistance to you or someone else regarding a possible Elmiron lawsuit, you can send can submit an online Elmiron Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.
[Read article in full at original source]Beovu: What Comes Next for This Troubled Novartis AMD Drug?
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“.
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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.
Elmiron Updates: Legal, Medical, and Regulatory – December 2020
In our final Drug Injury Watch article for 2020 we want to report on the recent developments regarding Elmiron lawsuits, Elmiron side effects warnings, and Elmiron pigmentary maculopathy diagnosis methods.
As regards the increasing number of Elmiron lawsuits for patients who have suffered vision loss due to Elmiron pigmentary maculopathy, there is now a federal court Elmiron MDL consolidation. On December 15, 2020, this JPML Order, “IN RE: ELMIRON (PENTOSAN POLYSULFATE SODIUM) PRODUCTS LIABILITY LITIGATION – MDL No. 2973“, was issued. The Elmiron MDL has been assigned to Judge Brian R. Martinotti for coordinated or consolidated proceedings, and all current Elmiron lawsuits filed in the U.S. federal court system will be transferred to the District of New Jersey.
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Turning to Elmiron side effects warnings developments, on December 15, 2020, a Dear Healthcare Professional Letter titled, “ELMIRON (pentosan polysulfate sodium) and the Risk of Pigmentary Maculopathy”, was issued in Canada by Janssen, Inc. and Health Canada. Its key messages were: (1) Cases of Elmiron pigmentary maculopathy have been reported with long-term use of Elmiron; and (2) Elmirion is now contraindicated in patients with a previous history of any macular pathology.
Lastly, there is some new information about Elmiron pigmentary maculopathy diagnosis methods. A December 22, 2020, medical article, “From Bladder Pain to Blurry Vision: Pentosan Polysulfate Sodium and the Development of a Novel Maculopathy”, published in Ophthalmic Surgery, Lasers and Imaging Retina, discusses the symptoms of pigmentary maculopathy as well as how doctors might diagnose this serious eye disease which may lead to significant vision loss.
Our law firm is investigating possible Elmiron lawsuits for patients who have suffered vision loss due to Elmiron pigmentary maculopathy. If we can be of assistance to you or someone else regarding an Elmiron vision loss case, you can submit an online Elmiron Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.
[Read article in full at original source]Beovu Retinal Vasculitis Made Worse by a Later Lucentis Treatment: Case Report
A recent medical journal article presents an interesting case report about a 76-year-old woman with Beovu-related retinal vasculitis which was made worse by a later Lucentis treatment for her wet AMD. That patient’s doctors are the authors of “Brolucizumab-related retinal vasculitis with exacerbation following ranibizumab retreatment: A clinicopathologic case study”, which suggests this was a Beovu vision loss case due to delayed Beovu hypersensitivity.
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In more detail, this woman was treated with three injections of Beovu resulting in retinal vasculitis and intraocular inflammation one week after the Beovu third injection. About one month later, her doctors administered a Lucentis treatment. Soon thereafter this patient developed severe vitritis with worsening occlusive retinal vasculitis.
When reading this Beovu case report it appears this woman’s doctors were not sure whether (1) Lucentis had a role in the retinal occlusive vasculitis, worsening intraocular inflammation, and severe vision loss she suffered soon after her Lucentis injection, or (2) this was a Beovu vision loss case due to delayed Beovu hypersensitivity.
In the Abstract for this Beovu case report, however, we find this statement at the “Conclusion and importance” part:
Treatment with [Beovu (brolucizumab)] can result in intraocular inflammation and retinal vasculitis likely due to a delayed hypersensitivity reaction to the drug, supported by cytopathologic analysis of a vitreous sample. We demonstrate a case where retreatment with an alternative anti-VEGF agent resulted in worsening vision and vasculitis.
Our law firm is investigating possible Beovu lawsuits for patients who have been diagnosed with Beovu-related retinal vasculitis and suffered vision loss or blindness. If we can be of assistance to you or someone else regarding a Beovu vision loss case, you can submit an online Beovu Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.
[Read article in full at original source]Beovu-related Retinal Vasculitis and Beovu Vision Loss Cases
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.
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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.
[View article in full at original source]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:
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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:
- Retinal vasculitis and/or retinal vascular occlusion can occur as early as the first or second Beovu injections; and,
- 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.
[Read article in full at original source]Gilenya Linked To Acute Liver Failure, Drug-induced Liver Injury
As reported in this European Medicines Agency (EMA) periodic safety update report, “Gilenya (fingolimod): Updated recommendations to minimise the risk of drug-induced liver injury (DILI)”, published November 10, 2020, there have been cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya.
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A Direct Healthcare Professional Communication document which was part of the November 2020 EMA periodic safety update provides these details about the cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya:
Following the most recent periodic review of safety data, three cases of liver failure requiring liver transplant have been reported in patients treated with [Gilenya (fingolimod)], including one case implying a strong causal relationship with [Gilenya (fingolimod)]. Cases of clinically significant liver injury have also been reported. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have occurred as early as ten days after the first dose and have also been reported after prolonged use.
We will continue to monitor the Gilenya safety profile with special attention to cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya.
[Read article in full at original source]Beovu Legal Cases: Compensation for Eye Problems from Beovu Use
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. Such drug injury Beovu legal cases might involve one or more of the following Beovu eye-related side effects:
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Vision Loss
Blindness
Occlusive Retinal Vasculitis
Retinal Vasculitis
Retinal Artery Occlusion
Intraocular Inflammation
Eye Inflammation
Endophthalmitis
Retinal Detachment
Uveitis
These Beovu side effects can develop soon after the very first Beovu injection a patient receives or following a few Beovu injections, according to medical case reports submitted to the FDA.
As a result of this Beovu drug injury situation, Beovu lawsuits will likely be filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to warn doctors about those serious Beovu side effects.
We have created a Beovu timeline which indicates why such drug injury Beovu legal cases could be filed against Novartis. The points of interest included in this Beovu timeline are the discovery of Beovu side effects that can lead to vision loss and blindness. statements by Novartis about Beovu drug safety issues, and more. Our Beovu timeline is updated as we learn more.
You can get a quick overview of Beovu lawsuits for vision loss, blindness, and other serious eye problems on the Beovu information page for our Drug Injury Law website.
Please feel free to send an email to Tom Lamb if we can be of assistance to you or someone else regarding these drug injury Beovu legal cases. Or you can call us on our toll-free number: 800-426-9535.
[Read article in full at original source]Global Picato Recall Due to Picato Skin Cancer Risk Findings Update
There have been several Picato recall announcements around the world during the past year. All of these are due to Picato skin cancer risk findings by drug safety regulators.
As reported in this October 28, 2020 item, “Denmark’s LEO Pharma initiates Picato phase-out”, published on thepharmaletter.com site:
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Following safety warnings on Picato (ingenol mebutate) from regulators, including the European Medicines Agency and the US Food and Drug Administration, Danish drugmaker LEO Pharma yesterday announced it was initiating a phase-out for the product, a gel for the treatment of actinic keratosis, which is expected to be completed by year-end 2020 at the latest as follows:
In the USA, LEO Pharma provided the FDA with notification of the permanent discontinuation in the manufacture of Picato and the withdrawal of New Drug Application (NDA) 202833 as Picato will no longer be marketed.
In Australia, LEO Pharma has already informed wholesalers and prescribers about discontinuation of Picato and will be withdrawing the marketing authorization.
And, in late October 2020, Health Canada announced a Picato recall due to the Picato skin cancer risk finding findings. Specifically Health Canada found “that there may be a link between PICATO and an increased risk of non-melanoma skin cancer”, as explained in this document: “PICATO (ingenol mebutate gel, 0.015% and 0.05%) – Product Withdrawal in Canada due to Potential Increased Risk of Skin Cancer”.
We will continue to monitor significant developments as regards the Picato skin cancer risk findings as well as watch for ramifications of the 2020 global Picato recall.
[Read article in full at original source]All content by attorney Tom Lamb