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Off-Topic Alert: Breast Implants Lymphoma Cancer Diagnosed More Often as Time Goes On
There is some new medical research about current population-based estimates of the incidence of breast implants-associated anaplastic large cell lymphoma (BIA-ALCL) — more commonly called breast implants lymphoma cancer — in the US, and the findings are rather alarming.
From this recent news report, “ALCL Increasing Rapidly in US Women as Breast Implants Rise“, about that recent medical journal article:
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The team, led by Connor Kinslow, MD, Columbia University, New York City, looked at the age-adjusted annual incidence rate of ALCL and found that it increased over time.
The incidence was 3.2 per 100 million persons per year from 2000-2005, then increased to 4.4 per 100 million persons per year from 2006-2011, and then tripled to an incidence of 14.5 per 100 million persons per year from 2012-2018….
These current incidence estimates are much higher than the previous estimate of 3 per 100 million persons per year quoted by the Food and Drug Administration (FDA), which had been based on data from the Surveillance, Epidemiology and End Results (SEER) data base from 2001-2007, the authors note.
“These trends are concerning, as the use of textured implants increased more than 5-fold from 2.3% to 13% of augmentation procedures between 2011 and 2015, despite a safety communication from the FDA in 2011,” they comment.
Our law firm has been representing several women diagnosed with breast implants lymphoma cancer. As such, we are monitoring the BIA-ALCL medical situation and will present add significant developments going forward on the Breast Implants Lymphoma Cancer page on our law firm website, where we offer a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.
[Read article in full at original source]Copiktra May Increase Risks of Death and Serious Side Effects
From this June 30, 2022, FDA Drug Safety Communication, “FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)”, we get the following:
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To evaluate the long-term safety of Copiktra, we required the drug manufacturer, Secura Bio, to submit the final 5-year survival results from the clinical trial, called DUO trial, a phase 3, randomized, open-label trial. It was conducted in 319 patients with CLL or SLL who received a previous therapy that did not work or stopped working. These final results showed a possible increased risk of death with Copiktra…. The serious side effects included infections, diarrhea, inflammation of the intestine and lungs, skin reactions, and elevated liver enzyme levels in the blood….
As background, Copiktra was approved by the FDA in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies that did not work or stopped working.
We will be watching for a future FDA Advisory Committee Meeting that will discuss the Copiktra clinical trial findings and, in turn, further assess the safety of Copiktra. Be assured we will report here about any significant developments, including whether Copiktra should continue to be prescribed for CLL and/or SLL cancer patients.
[Read article in full at original source]Xalkori Side Effects: Children Suffering Ocular Toxicity and Severe Visual Loss
A June 14, 2022, European Pharmaceutical Review (EPR) article about the most recent meeting of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reports a new drug safety issue involving Xalkori-related vision disorders found in clinical trials for pediatric patients treated with Xalkori.
In relevant part from this EPR article about the EMA’s PRAC June meeting highlights:
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Xalkori has been studied in children from six to 18 years of age as a monotherapy for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK positive or patients with unresectable, recurrent, or refractory ALK positive inflammatory myofibroblastic tumour (IMT).
Vision disorders have been reported in 61 percent of paediatric patients treated with [Xalkori (crizotinib)] in clinical trials for these indications.
We point out there were some revisions made in January 2021 to the “5.5 Severe Visual Loss” part of the WARNINGS AND PRECAUTIONS section in the Xalkori Prescribing Information document, but this pertained to patients generally, not pediatric patients only.
To date, however, we have not seen any similar FDA warning about this new drug safety issue involving Xalkori-related vision disorders for children.
We will continue to monitor the drug regulatory sector as well as the medical literature for further developments concerning ocular toxicity and severe visual loss in children treated with Xalkori.
[Read article in full at original source]Ukoniq Death Risk is Reason for Ukoniq Drug Recall Says FDA
This June 1, 2022 document, “Drug Safety Communication: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns”, makes clear it is the Ukoniq death risk that was behind the recent Ukoniq drug recall:
Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, we determined the risks of treatment with Ukoniq outweigh its benefits….
This recent FDA action formalizes an April 15, 2022 announcement by TG Therapeutics Inc. that it is pulling Ukoniq from the market after a study showed a possible increased risk of death in patients using Ukoniq.
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In connection with this recent Ukoniq drug recall due to the Ukoniq death risk, 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.
We encourage you to submit a Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible Ukoniq drug injury case.
[Read article in full at original source]Drug Injury Research: FDA Resources Online Available for Patients
In order to make sure that you are using credible sources if and when you want to do some drug injury research, there is an FDA information site and an FDA database that is searchable which we want you to know are available online.
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(1) Drug Safety Communications
This webpage was developed to provide the public with easy access to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare Professional sheets, and Public Health Advisories issued prior to January 29th, 2010. You can also find drug specific information using the Index to Drug-Specific Information.
(2) Drug Safety-related Labeling Changes (SrLC)
The Drug Safety-related Labeling Changes (SrLC) database provides approved safety-related labeling changes from January 2016 forward. Data prior to January 2016 will continue to be available on the MedWatch website.
If you or someone you know experienced serious side effects that may have been caused by an FDA-approved prescription medicine, you may want to do some drug injury research.
Our law firm has been representing patients and their families in drug injury lawsuits for the past 23 years. If our firm might be of assistance, we encourage you to submit a Drug Injury Case Evaluation Form –- it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak with us about a possible drug injury legal compensation case.
[Read article in full at original source]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]All content by attorney Tom Lamb