Side Effects Blog

During February 2023 there were recalls of Global Pharma eye products, specifically:

1. EzriCare Artificial Tears
2. Delsam Pharma’s Artificial Tears
3. 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.

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.

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.

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.

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).

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.

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.

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”.

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.

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.