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Side Effects Blog | Drug injury lawyer Tom Lamb keeps you informed about recent developments concerning prescription drug side effects and adverse reactions with his new articles.
Delsam and EzriCare Eye Products Recall: March 2023 Update
Here is the most recent information from the US Centers for Disease Control and Prevention (CDC) about the Global Pharma eye products recall for case reports associated with bacterial contamination:
As of March 1, 2023, CDC, in partnership with state and local health departments, identified 64 patients in 13 states (CA, CO, CT, FL, IL, NJ, NM, NY, NV, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. Thirty-seven patients were linked to four healthcare facility clusters. One person has died and there have been 8 reports of vision loss. Dates of specimen collection were from May 2022 to January 2023.
Source: CDC Healthcare-Associated Infections document “Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears” (accessed 3/1/23)
To read more of this article, click below:
During February 2023 there were recalls of Global Pharma eye products, specifically:
- EzriCare Artificial Tears
- Delsam Pharma’s Artificial Tears
- Delsam Pharma’s Artificial Eye Ointment
Timeline for Global Pharma Eye Products Recall
- 2/1/2023: The CDC issued a warning about this Global Pharma eye product, EzriCare Artificial Tears, associated with serious eye infections in patients from various states during recent months.
- 2/2/2023: Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears as well as a second Global Pharma eye product, Delsam Pharma’s Artificial Tears.
- 2/21/2023: First announcement by the FDA about Delsam Pharma’s Artificial Eye Ointment is a warning not to purchase or use this different type of Global Pharma eye product.
- 2/22/2023: Second announcement by the FDA, one day later, is about a Delsam Pharma’s Artificial Eye Ointment recall by Global Pharma.
For more information, see our earlier articles about this Global Pharma eye products recall:
Delsam Pharma’s Artificial Eye Ointment Recall February 2023 (2/23/23)
EzriCare and Delsam Pharma’s Eye Drops Products Recall (2/8/23)
EzriCare Artificial Tears Eye Infections Warnings (2/7/23)
We are investigating cases involving hospitalization, death, or permanent vision loss from an infection due to bacterial contamination in connection with this Global Pharma eye products recall.
Let us know if we can be of assistance to you or someone you know by submitting an online Case Evaluation Form or calling us at 800-426-9535.
[Read article in full at original source]Delsam Pharma’s Artificial Eye Ointment Recall February 2023
In late February the FDA announced a Delsam Pharma’s Artificial Eye Ointment recall by Global Pharma a day after warning not to use this eye product due to a potential Artificial Eye Ointment contamination problem.
We are investigating cases involving hospitalization, death, or permanent vision loss from an eye infection due to the Artificial Eye Ointment contamination problem. These cases are possible drug injury lawsuits that would be filed against Global Pharma.
It is expected that there will be more information coming from the FDA about this Delsam Pharma’s Artificial Eye Ointment recall in the coming weeks and months.
To read more of this article, click below:
Here are two earlier articles we posted about a similar bacterial contamination problem for two other OTC eye products from Global Pharma, EzriCare Artificial Tears and EzriCare Artificial Tears lubricant eye drops.
“EzriCare and Delsam Pharma’s Eye Drops Products Recall” (2/8/23)
“EzriCare Artificial Tears Eye Infections Warnings” (2/7/23)
Let us know if we can be of assistance concerning the recent Delsam Pharma’s Artificial Eye Ointment recall or with a possible drug injury lawsuit arising out of the Artificial Eye Ointment contamination problem.
[Read article in full at original source]EzriCare and Delsam Pharma’s Eye Drops Products Recall
In early February 2023 there was an artificial tears eye drops products recall involving EzriCare and Delsam Pharma’s Artificial Tears.
As a standard practice, when a drug company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. Here is the Global Pharma Healthcare announcement about this eye drops products recall involving EzriCare and Delsam Pharma’s Artificial Tears products in February 2023: “Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination“.
To read more of this article, click below:
Importantly, this Global Pharma Healthcare recall announcement includes a “Product Photos” part at the end which will help people figure out if they should be concerned about this artificial tears eye drops products recall involving EzriCare and Delsam Pharma’s Artificial Tears products.
We are investigating cases involving hospitalization, death, or permanent vision loss related to these eye drops products recall as possible drug injury lawsuits that would be filed against Global Pharma Healthcare, the company which is responsible for EzriCare and Delsam Pharma’s Artificial Tears.
[Read article in full at original source]EzriCare Artificial Tears Eye Infections Warnings
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:
To read more of this article, click below:
- Discontinue using EzriCare Artificial Tears pending additional guidance from CDC and FDA.
- 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.
- 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]Valtrex Drug Side Effect: DRESS Skin Reaction, Can be Fatal
According to the Health Product InfoWatch December 2022 edition released by Health Canada on December 22, 2022, cases of Valtrex-associated DRESS have been reported as a Valtrex drug side effect. Further, therein, it is reported that GlaxoSmithKline Inc. has updated the Canadian product monograph for Valtrex to add information about the risk of Valtrex-associated DRESS.
To read more of this article, click below:
Valtrex (valacyclovir) is a long-established treatment for cold sores, genital herpes, and herpes zoster, having been initially approved by the FDA in 1995. The Full Prescribing Information document for Valtrex in the United States does not currently have any discussion of or warning about Valtrex-associated DRESS as a possible Valtrex drug side effect. We will watch to see whether the FDA follows the lead of Health Canada and require a Valtrex drug label change to add information about drug reaction with eosinophilia and systemic symptoms (DRESS).
[Read article in full at original source]Four Tepezza Drug Side Effects Medical Articles That Focus on Hearing Issues
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:
To read more of this article, click below:
- “Hearing Loss and [Tepezza (teprotumumab)]“
- “Hearing Dysfunction After Treatment With [Tepezza (teprotumumab)] for Thyroid Eye Disease“
- “Sensorineural Hearing Loss After [Tepezza (teprotumumab)] Therapy for Thyroid Eye Disease: A Case Report“
- “[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]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
To read more of this article, click below:
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.
[Read article in full 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):
To read more of this article, click below:
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:
To read more of this article, click below:
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:
To read more of this article, click below:
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]All content by attorney Tom Lamb