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Tepezza Hearing Loss, Other Tepezza Hearing Problems May be Irreversible and Permanent
Tepezza hearing loss and other Tepezza hearing problems have been reported by medical doctors and patients since this treatment for Thyroid Eye Disease was approved by the FDA in 2020.
Those Tepezza hearing problems have involved various medical diagnosis types, including:
Hypoacusis: hearing loss ranging from impairment to deafness
Sensorineural Hearing Loss (SNHL): type of hearing loss resulting from damaged hair cells in the inner ear
Hyperacusis: sound or noise sensitivity that makes it hard to deal with everyday sounds
Tinnitus: ringing in the ears in the absence of an external source
Autophony: unusually loud hearing of one’s own voice, breathing, and other bodily sounds
Eustachian Tube Dysfunction: sensations of ears being “plugged” or “full” resulting in muffled hearing
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There is not any mention of Tepezza hearing loss or Tepezza hearing problems in the “Warnings and Precautions” section nor in the “Adverse Reactions” section of the Tepezza Full Prescribing Information, which is sometimes referred to as the Tepezza drug label.
The possibility that Tepezza hearing loss and other Tepezza problems can be irreversible and permanent is a subject that has been examined in several recent medical journal articles about Tepezza (teprotumumab). There are case reports, in fact, where the patient’s hearing loss was still present several months after they stopped their Tepezza use, and the level of hearing function was still not back to where it had been before their Tepezza use.
As background, in January 2020 Tepezza received approval from the FDA for the treatment of Thyroid Eye Disease (TED) — which is also referred to as:
- Graves’ disease;
- Graves’ eye disease (GED);
- Graves’ orbitopathy; and,
- Graves’ ophthalmopathy.
We are investigating possible Tepezza drug injury cases where the patient, while using Tepezza, started to experience hearing loss or other hearing problems, such as:
- Hearing loss, ranging from impairment to deafness — also known as Hypoacusis, and sometimes Sensorineural Hearing Loss (SNHL)
- Sound or noise sensitivity that makes it hard to deal with everyday sounds — also known as Hyperacusis
- Ringing in the ears in the absence of an external source– also known as Tinnitus
- Unusually loud hearing of one’s own voice, breathing, and other bodily sounds — also known as Autophony
- Sensations of ears being “plugged” or “full” resulting in muffled hearing — also known as Eustachian Tube Dysfunction
If you or someone you know has a possible Tepezza hearing side effects case, we encourage you to submit a Drug Injury Case Evaluation Form — it is free, confidential, and there is no obligation.
[View full article at original source]FDA AdComm: Copiktra Risk-Benefit Profile No Longer Favorable as a Third-Line CLL/SLL Treatment
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 8-4 against the Copiktra risk-benefit profile, as reported in this September 23, 2022, Endpoint News article, “FDA adcomm takes down Secura Bio’s leukemia drug after final trial results show potential OS detriment”.
From that recent news report about the safety of Copiktra (duvelisib):
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ODAC chair Jorge Garcia said ultimately these data do not support that this agent prolongs life. Other panelists who voted against it said, “We are playing with fire,” and that it didn’t meet the bar for safety, and that the data are hard to interpret and have concerns about this class of medicines.
And we were directed to some additional information about the Copiktra risk-benefit profile in his September 22, 2022, Fierce Pharma article, “FDA threatens to clamp down on another PI3K blood cancer drug—this time a full approval”:
In a briefing document prepared for an FDA oncology advisory committee meeting set to take place Sept. 23, the FDA laid bare its concerns over the toxicity of Secura Bio’s Copiktra and how the drug could detrimentally impact the life expectancy of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Recapping, at a September 2022 Advisory Committee Meeting, the FDA was asking its external experts to weigh in on whether the Copiktra risk-benefit profile is still favorable as a third-line CLL/SLL cancer treatment, and the majority of those experts voted “No”.
[Read article in full at original source]Gallbladder Side Effects Related to Byetta and Other GLP-1 Receptor Agonists
Cases of gallbladder side effects related to Byetta, Trulicity, Ozempic, and Adlyxin were reported in this August 2022 medical journal JAMA Internal Medicine article, “Acute cholecystitis associated with the use of glucagon-like peptide-1 receptor agonists reported to the US Food and Drug Administration”, which starts with the following:
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The required labeling for some glucagon-like peptide-1 receptor agonists (GLP-1 RAs) indicated for glycemic control in patients with type 2 diabetes include warnings and precautions regarding acute gallbladder disease in the US Prescribing Information (the prescribing information approved by the US Food and Drug Administration [FDA]), while others do not. The FDA recently reviewed the FDA Adverse Event Reporting System (FAERS) to identify cases of acute cholecystitis (AC) associated with the GLP-1 RA products that did not have warnings and precautions regarding acute gallbladder disease.
We get more details from this August 30, 2022 MedPage Today news report, “FDA Data Link Diabetes Drug Class to Gallbladder Disease”:
An analysis of FDA’s reporting system for adverse events turned up three dozen cases of [ gallbladder side effects ] in patients taking glucagon-like peptide-1 (GLP-1) receptor agonists for diabetes or weight loss, including three deaths.
From 2005 to 2016, postmarketing cases of acute cholecystitis were identified in 21 patients taking exenatide (Byetta), in seven taking dulaglutide (Trulicity), in seven on semaglutide (Ozempic), and in one patient taking lixisenatide (Adlyxin)….
We will continue to watch for cases of gallbladder side effects related to Byetta, Trulicity, Ozempic, and Adlyxin for diabetes or weight loss.
[Read article in full at original source]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]All content by attorney Tom Lamb