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Law Offices of Thomas J. Lamb

EzriCare Artificial Tears Eye Infections Warnings

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There is detailed information about the  in this Centers for Disease Control and Prevention (CDC) Outbreak and Patient Notifications article, “Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears”, including this fact:

As of January 31, 2023, CDC, in partnership with state and local health departments, identified 55 patients in 12 states (CA, CO, CT, FL, NJ, NM, NY, NV, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa.

The CDC warnings for these EzriCare Artificial Tears eye infections include the following:

  1. Discontinue using EzriCare Artificial Tears pending additional guidance from CDC and FDA.
  2. If patients were advised to use EzriCare Artificial Tears by their healthcare provider, they should follow up with their healthcare provider for an alternative artificial tears product to use.
  3. Patients who used EzriCare Artificial Tears and who have signs or symptoms of an eye infection, such as discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, feeling of something in the eye, increased sensitivity to light, or blurry vision, should seek timely medical care. At this time, CDC does not recommend testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.

Those were taken from this February 1, 2023, CDC document, “Health Alert Network (HAN) No. 485 – Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa associated with Artificial Tears”, which provides a quick overview of these EzriCare Artificial Tears eye infections.

We are investigating cases of EzriCare Artificial Tears eye infections as possible drug injury lawsuits that would be filed against Global Pharma Healthcare, the company responsible for this lubricant eye drops product.

[Read article in full at original source]

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Four Tepezza Drug Side Effects Medical Articles That Focus on Hearing Issues

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We are investigating possible Tepezza drug injury cases where the patient, while using Tepezza, started to experience hearing loss or other hearing problems. Specifically, those Tepezza drug side effects that involve hearing include:

  • Hearing loss, ranging from impairment to deafness (Hypoacusis and Sensorineural Hearing Loss)
  • Sound or noise sensitivity that makes it hard to deal with everyday sounds (Hyperacusis)
  • Ringing in the ears in the absence of an external source (Tinnitus)
  • Unusually loud hearing of one’s own voice, breathing, and other bodily sounds (Autophony)
  • Sensations of ears being “plugged” or “full” resulting in muffled hearing (Eustachian Tube Dysfunction)

In this article we present four medical journal articles discussing Tepezza drug side effects that involve hearing:

  1. “Hearing Loss and [Tepezza (teprotumumab)]“
  2. “Hearing Dysfunction After Treatment With [Tepezza (teprotumumab)] for Thyroid Eye Disease“
  3. “Sensorineural Hearing Loss After [Tepezza (teprotumumab)] Therapy for Thyroid Eye Disease: A Case Report“
  4. “[Tepezza (teprotumumab)] and Hearing Loss: Case Series and Proposal for Audiologic Monitoring“

For those people experiencing Tepezza drug side effects that involve hearing, we encourage you to submit a Drug Injury Case Evaluation Form — it is free, confidential, and there is no obligation.

[Read article in full at original source]

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Tepezza Hearing Loss, Other Tepezza Hearing Problems May be Irreversible and Permanent

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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

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:

  1. Graves’ disease;
  2. Graves’ eye disease (GED);
  3. Graves’ orbitopathy; and,
  4. 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.

[Read article in full at original source]

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FDA AdComm: Copiktra Risk-Benefit Profile No Longer Favorable as a Third-Line CLL/SLL Treatment

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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):

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]

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Copiktra May Increase Risks of Death and Serious Side Effects

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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:

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]

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Xalkori Side Effects: Children Suffering Ocular Toxicity and Severe Visual Loss

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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:

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]

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Ukoniq Death Risk is Reason for Ukoniq Drug Recall Says FDA

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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.

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]

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Ukoniq Was Pulled From Market Due to Increased Risk of Patient Deaths

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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.

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]

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MS Drugs Ocrevus and Gilenya Linked to Melanoma, Other Skin Cancers

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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:

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:

  1. The findings showed the MS drugs Ocrevus and Gilenya were linked to melanoma skin cancer: and,
  2. 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]

Gilenya | Lemtrada | Mayzent | Ocrevus

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Fosamax Lawsuits Dismissed Again by March 2022 Preemption Ruling

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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.

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:

  1. 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,
  2. 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]

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