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Ukoniq Was Pulled From Market Due to Increased Risk of Patient Deaths
The drug company responsible for the lymphoma medicine Ukoniq (umbralisib), TG Therapeutics, indicated in April 2022 that Ukoniq was pulled from the market due to an increased risk of death in patients using Ukoniq.
This April 15, 2022 Dow Jones piece, “TG Therapeutics Pulls Sole Product Ukoniq Amid Increased Death Risk”, summarizes why Uknoniq was pulled from the market.
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TG Therapeutics Inc. on Friday said it is pulling its Ukoniq lymphoma treatment from the market after a study showed a possible increased risk of death in patients taking the drug.
The New York biopharmaceutical company also said it is withdrawing its application seeking U.S. Food and Drug Administration approval of Ukoniq in combination with ublituximab for the treatment of adults with chronic lymphocytic leukemia and small lymphocytic lymphoma.
TG Therapeutics said it made the decision after recently updated overall-survival data from a Phase 3 study of the combination showed an increasing survival imbalance in favor of the control arm.
This April 15, 2022 company Press Release, “TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SLL”, provides the drug company’s reasoning for why Uknoniq was pulled from the market.
In connection with the apparent fact that Ukoniq was pulled from the market for safety reasons, we are investigating possible Ukoniq drug injury lawsuits against TG Therapeutics for cases involving patient deaths or serious side effects that may have been caused by Ukoniq.
[Read article in full at original source]MS Drugs Ocrevus and Gilenya Linked to Melanoma, Other Skin Cancers
Multiple sclerosis (MS) drugs Ocrevus and Gilenya have been linked to melanoma, with Gilenya linked to squamous cell carcinoma and basal cell carcinoma, also. These new drug safety findings come from an analysis of skin cancers reported to the FDA Adverse Event Reporting System (FAERS) for patients receiving certain multiple sclerosis (MS) therapies, including the drugs Gilenya, Lemtrada, Mayzent, and Ocrevus.
From the Conclusion part of this medical research article, “S1P receptor modulators in Multiple Sclerosis: Detecting a potential skin cancer safety signal”, published by the medical journal Multiple Sclerosis and Related Disorders:
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The present study detected a potential safety signal for the S1P receptor modulators [Gilenya (fingolimod)] and [Mayzent (siponimod)] for basal cell carcinomas. [Gilenya (fingolimod)] had also an increased signal of disproportionate reporting for melanoma and squamous cell carcinoma. [Lemtrada (alemtuzumab)] presented also a signal for all three types of skin cancer, while [Ocrevus (ocrelizumab)] presented a potential safety signal for melanoma.
This February 22, 2022, Multiple Sclerosis News Today article, “More Skin Cancer Reported to FDA From Patients on Certain Oral DMTs”, points out these two important facts:
- The findings showed the MS drugs Ocrevus and Gilenya were linked to melanoma skin cancer: and,
- The findings showed Gilenya was linked to squamous cell carcinoma and basal cell carcinoma, also.
We will continue to monitor the safety profile of Ocrevus and Gilenya, as well as Lemtrada and Mayzent, with a focus on the possible increased risks of melanoma, squamous cell carcinoma, and basal cell carcinoma.
[Read article in full at original source]Fosamax Lawsuits Dismissed Again by March 2022 Preemption Ruling
There are about 500 women who used Fosamax, suffered femur fractures, and then filed a product liability lawsuit against Merck. Their lawsuit had been pending in the federal court Fosamax MDL for ten years or more. In an unfortunate but not altogether unexpected development, in March 2022 their Fosamax lawsuits were dismissed a second time as a result of the federal preemption legal defense asserted by Merck. Understandably, For some of those women this will be adding insult to injury, so to speak.
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In more detail, on March 23, 2022, these Fosamax lawsuits were dismissed by means of an opinion issued by Judge Freda Wolfson. Previously, these Fosamax lawsuits had been dismissed in 2013, but that ruling was appealed by the women who were plaintiffs in these femur fracture cases. After several years of legal procedures, these Fosamax lawsuits were remanded to the District of New Jersey in late 2019 by the U.S. Court of Appeals for the Third Circuit. This was the result of a May 2019 Supreme Court ruling in Merck Sharp & Dohme Corp. v. Doris Albrecht, et al., a Fosamax femur fracture case. Given this timeline, the women who filed these federal court Fosamax lawsuits had been waiting for this recent federal preemption ruling by Judge Wolfson for more than two years — only to find out, after that long wait, that Merck had prevailed again.
The March 23, 2022 Opinion for the federal court Fosamax lawsuits pending in the MDL captioned In Re Fosamax (Alendronate Sodium) Products Liability Litigation is lengthy and full of legal reasoning. In essence, however, Judge Wolfson ruled that:
- The FDA rejected a proposed warning submitted by Merck about a causal link between Fosamax and femur fractures because the FDA felt there was insufficient for such a Fosamax drug label change at that time; and,
- The evidence was clear and convincing that the FDA would not have approved a similar but differently worded warning if one had been submitted soon thereafter.
As pointed out above, the outcome of Judge Wolfson’s analysis was that the plaintiffs’ state-law failure-to-warn claims must be dismissed due to federal preemption, which is the ruling made by Judge Wolfson in her recent Fosamax MDL Opinion.
[Read article in full at original source]April 2022 FDA Advisory Committee Meeting For Ukoniq Risk of Death
We first learned from this March 10, 2022 press release item, “TG Therapeutics Announces Scheduling of Planned Oncologic Drug Advisory Committee Meeting”, that the Ukoniq FDA Advisory Committee meeting will be held on April 22, 2022. This development relates back to a Drug Safety Communication, “FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)”, issued in early February 2022. Therein, a so-called “safety signal” for Ukoniq was identified by the FDA. There were news reports back in February that mentioned there would likely be an Ukoniq FDA Advisory Committee meeting for evaluating this new Ukoniq drug safety issue.
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For more on this recent Ukoniq drug safety issue, we refer you to our February 4, 2022 article, “Ukoniq Lymphoma Drug Safety Investigation Started In February 2022 to Examine Increased Risk of Death“.
To learn more about this Ukoniq FDA Advisory Committee meeting, including the availability of background material prior to the meeting and a link to the online teleconference meeting room, see April 21-22, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement.
We will continue to monitor this Ukoniq drug safety issue involving an increased risk of death, and report on any drug regulatory actions that might come after the upcoming April 2022 Ukoniq FDA Advisory Committee meeting.
[Read article in full at original source]Beovu Label Change: Novartis Adds Information, Increases Safety Warnings in February 2022
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)“.
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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.
[Read article in full at original source]Xeljanz, Rinvoq, and Olumiant Safety Review by European Drug Regulator EMA
The JAK inhibitors drug class safety issue has landed in Europe, as indicated by this European Medicines Agency (EMA) February 11, 2022, news item, “EMA starts safety review of Janus kinase inhibitors for inflammatory disorders”. This Xeljanz, Rinvoq, and Olumiant safety review by the EMA follows a December 2021 JAK inhibitors drug class safety FDA action in the US, with Xeljanz, Rinvoq, and Olumiant getting revised drug labels adding more side effects warnings and more drug use restrictions.
Consistent with the December 2021 JAK inhibitors label changes mandated by the FDA here in the US, this February 2022 EMA Xeljanz, Rinvoq, and Olumiant safety review focuses on these JAK inhibitors as treatments for inflammatory disorders.
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From the above-referenced EMA news item:
The review was prompted by the final results from a clinical trial (study A3921133) of the JAK inhibitor Xeljanz (tofacitinib). The results showed that patients taking Xeljanz for rheumatoid arthritis and who were at risk of heart disease were more likely to experience a major cardiovascular problem (such as heart attack, stroke or death due to cardiovascular disease) and had a higher risk of developing cancer than those treated with medicines belonging to the class of TNF-alpha inhibitors….
In addition, preliminary findings from an observational study involving another JAK inhibitor, Olumiant (baricitinib), also suggest an increased risk of major cardiovascular problems and VTE in patients with rheumatoid arthritis treated with Olumiant compared with those treated with TNF-alpha inhibitors.
Our law firm is investigating possible drug injury lawsuits involving Xeljanz, Rinvoq, and Olumiant for patients who have suffered serious side effects or adverse drug reactions. Feel free to contact us if you or someone you know might have a Xeljanz, Rinvoq, or Olumiant drug injury case.
And, of course, we will continue to watch for future developments related to JAK inhibitors drug class safety and JAK inhibitors label changes.
[Read article in full at original source]Possible Ukoniq Drug Recall Due to Increased Risk of Death
Ukoniq (umbralisib) was approved by the FDA in February 2021 to treat adults with two types of lymphoma cancer that have returned or it did not respond to prior treatment: Marginal Zone Lymphoma (MZL); and, Follicular Lymphoma (FL). Only a year later, however, there is a new FDA Ukoniq safety investigation after a so-called “safety signal” indicated an increased risk of death with Ukoniq that may lead to an Ukoniq drug recall.
For more detailed information about this Ukoniq safety signal, we refer you to this February 3, 2022, Drug Safety Communication, “FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)”. As seen in that second point, there may be an FDA Advisory Committee meeting to consider a possible Ukoniq drug recall in the near future.
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For more on the new FDA Ukoniq safety investigation and this possible Ukoniq drug recall, we turn to an article, “FDA Concerned About Safety of Lymphoma Drug”, by medical reported Charles Bankhead, which was published on February 3, 2022, by MedPage Today:
The FDA Oncologic Drugs Advisory Committee (ODAC) may also convene to consider the findings of the safety evaluation and “explore” the continued marketing of [Ukoniq (umbralisib)]….
Late last year, [Ukoniq (umbralisib)] sponsor TG Therapeutics issued a statement acknowledging that the FDA plans to convene ODAC to consider the UNITY-CLL data within the context of the ongoing review of the company’s application for approval of the [Ukoniq (umbralisib)]/ublituximab(U2) combination….
Although ODAC has yet to announce a date for the [Ukoniq (umbralisib)] review, the FDA indicated that the meeting would occur in March or April, according to TG Therapeutics.
We will continue to monitor the FDA Ukoniq safety investigation and watch for any related FDA regulatory action, including a possible Ukoniq drug recall in the future.
[Read article in full at original source]Xeljanz Safety Study Final Findings Presented in January 2022
The Xeljanz safety study final findings from the so-called “ORAL Surveillance” trial ordered by the FDA were examined in this January 26, 2022 article, “Trial Data Confirm Heightened Risks With JAK Inhibitor”, by medical news reporter John Gever for MedPage Today.
That January 2022 MedPage Today news report provides a “snapshot” of the current safety profile for Xeljanz as regards cancer and heart-related side effects:
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It’s official: full data from a randomized trial evaluating safety of the oral JAK inhibitor tofacitinib (Xeljanz), approved for treating rheumatoid arthritis and related disorders as well as ulcerative colitis, are now published — and they are not good.
Patients assigned to [Xeljanz] developed major adverse cardiovascular events (MACE) at a rate of 3.4% and new cancers were seen in 4.2% during a median 4 years of follow-up; for those treated with either adalimumab (Humira) or etanercept (Enbrel), the corresponding rates were 2.5% and 2.99%, respectively, according to a report in the New England Journal of Medicine.
This worked out to hazard ratios of 1.33 for MACE (95% CI 0.91-1.94) and 1.48 for incident cancers (95% CI 1.04-2.09), reported investigators led by Steven Ytterberg, MD, of the Mayo Clinic in Rochester, Minnesota….
In their paper, Ytterberg and colleagues stuck to reporting the trial’s results, offering no advice to patients or clinicians on how to interpret them.
For more detail, the January 27, 2022 edition of the New England Journal of Medicine (NEJM) has this article, “Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis”, which reports all of the final data for this ORAL Surveillance Xeljanz safety study.
Our law firm is investigating possible Xeljanz, Rinvoq, and Olumiant lawsuits for patients who have suffered any of these serious side effects or adverse drug reactions. We would like to help you or someone you know with a Xeljanz, Rinvoq, or Olumiant drug injury case. Please feel free to contact us, at your convenience.
[Read article in full at original source]Beovu Drug Label Revised December 2021 Was Issued in Europe, But Not in the US
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.
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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:
- “Risk factors identified”; and,
- “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.
[Read article in full at original source]This excerpt from the “Advisory – Health Canada safety review finds link between the use of Xeljanz and Xeljanz XR (tofacitinib) and increased risk of serious heart-related issues and cancer” issued in January 2022 provides an overview of the Xeljanz drug safety issue, and how the Xeljanz side effects risks may also apply to Olumiant and Rinvoq:
Health Canada completed a safety review that confirmed a link between the use of Xeljanz/Xeljanz XR and the increased risks of serious heart-related problems and cancer, especially in older patients, patients who are current or past smokers, and patients with cardiovascular or cancer risk factors. Health Canada’s review also found that all patients treated with Xeljanz 10 mg twice daily had a higher risk of death, blood clots and serious infections, compared to patients treated with Xeljanz 5 mg twice daily or tumour necrosis factor inhibitors (TNFi)….
Health Canada has also initiated a new safety review of the potential risks of serious heart-related problems, cancer and blood clots with two other drugs of the same class as Xeljanz/Xeljanz XR (i.e. Olumiant and Rinvoq) that work similarly for the treatment of similar diseases.
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The Health Canada Xeljanz Advisory gives some more detailed information in a section intended for healthcare professionals but, no doubt, of interest to patients using Xeljanz — as well as Olumiant or Rinvoq, perhaps:
- Inform patients that Xeljanz/Xeljanz XR may increase their risk of major adverse cardiovascular events including non-fatal myocardial infarction. Instruct all patients, especially geriatric patients, current or past smokers, or patients with other cardiovascular risk factors, to be alert for signs and symptoms of cardiovascular events.
- Inform patients that Xeljanz/Xeljanz XR may increase their risk of certain cancers, and that lung cancer, lymphoma and other cancers have been observed in patients taking Xeljanz. Instruct patients to inform their healthcare provider if they have ever had any type of cancer.
Our law firm is investigating possible drug injury lawsuits for patients who used Xeljanz, Olumiant, or Rinvoq and then suffered one of the serious side effects associated with these JAK inhibitors drugs. In particular, heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as cancers such as lymphoma and lung cancer.
[Read article in full at original source]All content by attorney Tom Lamb