Drug Injury Watch

Ozempic Gallbladder Injury Case Factors: When was the Ozempic Prescribed and For How Long?

March 2022 Ozempic Label Change About Risks of Gallbladder Disease is Just One Part of Legal Case Analysis

 

(Posted by Tom Lamb at Drug Injury Watch)

 

An Ozempic gallbladder disease warning was the subject of a March 2022 Ozempic drug label change by Novo Nordisk. Specifically, the following part was added to the Warnings and Precautions section of the Ozempic Prescribing Information document:

5.8 Acute Gallbladder Disease
Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

As background, cholelithiasis is more commonly referred to as gallstones, and cholecystitis is inflammation of the gallbladder. A person may require gallbladder removal surgery if other treatments do not relieve the inflammation and pain from gallstones. Cholecystectomy is the medical term for gallbladder removal surgery.

While this March 2022 Ozempic gallbladder label change is a significant part of the legal analysis for a possible Ozempic gallbladder injury case, there are other important factors also. Figuring out if there might be a drug injury lawsuit to file against Novo Nordisk for your gallbladder disease is not as simple as whether your gallbladder diagnosis was made before or after that March 2022 "line-in-the-sand" date.

If you were prescribed Ozempic before April 2022 and had gallbladder removal surgery or were hospitalized for gallbladder disease, you should have an experienced drug injury lawyer review your possible Ozempic drug injury lawsuit.

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Generally, the legal basis for an Ozempic gallbladder injury case against the responsible drug company is that Novo Nordisk failed to warn doctors and patients about the risks of gallbladder diseases in a timely manner. In more detail, the contention is that, when one views the March 2022 Ozempic drug label change in the context of what they knew and when they knew it, this Ozempic gallbladder disease warning should have been added earlier.

Going from the law to medicine, Ozempic (semaglutide) is classified as a glucagon-like peptide-1 receptor agonist (GLP-1 RA). One's use of GLP-1 receptor agonists like Ozempic has been associated with an increased risk of bile duct and gallbladder diseases such as cholelithiasis.

The medical literature in support of why Novo Nordisk might of been "late" in warning about the risks of Ozempic-related gallbladder removal, for example, includes the following research:

1. "Association of Bile Duct and Gallbladder Diseases With the Use of Incretin-Based Drugs in Patients With Type 2 Diabetes Mellitus" (2016)
2. "Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials" (2017)
3. "Cholelithiasis in patients treated with Glucagon-Like Peptide-1 Receptor: An updated meta-analysis of randomized controlled trials" (2020)

As pointed out in the title of this article, for the legal case analysis of an Ozempic drug injury lawsuit there are two important factors having to do with things other than when your gallbladder disease was first diagnosed or when you had gallbladder removal surgery.

First, what is the date (month/year) when your doctor prescribed Ozempic?

Second, was that Ozempic prescription for one month, a few months, or one year?

Of course, there are other considerations that we would discuss if you contact us about a possible Ozempic drug injury case involving gallbladder disease.

If we can be of assistance to you or someone you know, 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 Ozempic gallbladder injury case. Either way, you will get Mr. Lamb’s impressions about your Ozempic case based on his more than 20 years of experience handling drug injury lawsuits.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (Website content is written by Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Attorney Tom Lamb does all case reviews)

Trulicity Recall Due to Dose Labeling Error Back in 2021 May Still be Drug Safety Issue Today

Thousands of Trulicity Autoinjector Devices Labeled as 0.75 mg Might Contain 1.5 mg (i.e., a "double-dose")

 

(Posted by Tom Lamb at Drug Injury Watch)

 

A Trulicity recall back in August - September 2021 by Eli Lilly & Company was due to a dose labeling error involving a single lot of Trulicity (dulaglutide). That does not sound too alarming at first glance, but this incident becomes more concerning as a Trulicity drug safety issue when one takes a closer look.

First, some Trulicity autoinjector devices labeled as 0.75 mg/0.5 mL, in fact, contain 1.5 mg/0.5 mL of product.  As such, those Trulicity products can be viewed as "defective".

Second, this 2021 Trulicity recall affects 119,539 boxes of Trulicity 0.75 mg/0.5 mL single-dose pens, four pens per box (NDC 0002-1433-80), from lot D396436C.

Third, when the FDA issued its Enforcement Report for that Trulicity recall, the document did not include the lot’s expiration date or where the defective Trulicity products were manufactured.

Fourth, it was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.

Fifth, while the mislabeled Trulicity autoinjector devices were distributed throughout the United States, it appears that the associated Trulicity recall was only down to the retail level.

Sixth, it apparently took Eli Lilly at least two months, from mid-June 2021 to mid-August 2021 -- to realize that this double-dose lot of Trulicity had been shipped to US pharmacies to dispense for use by patients.

Lastly, even though the FDA designated this 2021 Trulicity recall as "Class II" -- by definition, meaning that use of this product could cause temporary or medically reversible adverse health consequences -- that FDA Class II designation also indicates there is a remote possibility of serious harm.

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For more details, see these two source documents:

1.  Recall Enforcement Report for FDA recall D-0773-2021, which starts as follows:

Drug Recall Enforcement Report Class II voluntary initiated by Eli Lilly & Company, originally initiated on 08-19-2021 for the product Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 The product was recalled due to labeling: label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 ml actually contain 1.5 mg / 0.5 ml of product. The product was distributed nationwide and the recall is currently ongoing.

2.  California State Board of Pharmacy Trulicity recall alert, which provides an important update:

The Board of Pharmacy has received notice of the following product recall. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required.

NOTE: UPDATED EXPIRATION DATE

Description: TRULICITY 0.75MG/0.5ML PEN 4

Lot #: D396436C

Exp Date: 01/27/2023

NDC: 00002143380

UPC: 30002143380

Eli Lilly is recalling the above item/lot due to a dose labeling error. This recall is to the retail level. Affected product started shipping June 14, 2021.

Significantly, neither of those two source documents tells us how many of the double-dose Trulicity boxes were dispensed by pharmacies to patients rather than returned by pharmacies to Eli Lilly.

In addition, even though the expiration date for this recalled double-dose Trulicity is stated as "01/27/2023", patients often overlook this type of preventive information.

For example, we were contacted by a woman who reportedly used one of these recalled Trulicity products in mid-February 2023 and was subsequently hospitalized for three days for seizures that may have been related to using twice the amount of Trulicity that had been prescribed by her doctor.

Given that this 2021 Eli Lilly / FDA Trulicity recall was rather "low-profile", and because there may still be thousands of double-dose Trulicity injectors in patients' homes, we are concerned that this is an ongoing Trulicity drug safety issue.

If you or someone you know may have suffered an adverse reaction as a result of using a Trulicity autoinjector device which was labeled as 0.75 mg but, later, it was determined the product contained 1.5 mg of Trulicity (a "double-dose"), we would be interested in hearing more about that event. It is possible that a Trulicity drug injury case could be filed against Eli Lilly, depending on the circumstances. For that purpose, one can submit a Case Evaluation Form to us for review.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Prolia - Hypocalcemia Side Effect Safety Signal May Draw Regulatory Action by FDA

"Risk of severe hypocalcemia" in Patients on Dialysis Receiving Osteoporosis Drug Prolia (denosumab)

 

(Posted by Tom Lamb at Drug Injury Watch)

 

The FDA is in the process of evaluating the osteoporosis drug Prolia (denosumab) to determine the need for regulatory action as regards a Prolia - hypocalcemia side effect safety signal according to this recent FDA information, "October - December 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)".

This relatively new Prolia - hypocalcemia side effect issue first came to our attention late last year with the release of this November 22, 2022 document, "FDA Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)".

For some background and context, we refer you to this November 2022 Medscape article, "FDA Alert: 'Substantial' Hypocalcemia Risk with Prolia Use in Dialysis Patients":

The FDA explained it issued the alert because of "the frequency and seriousness" of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.

The alert stemmed from "interim results" in an ongoing safety study of Prolia that the FDA required the agent's manufacturer, Amgen, to run when the agency first approved denosumab for US marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.

In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at "substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death."

Returning to the November 2022 FDA Drug Safety Communication about the Prolia - hypocalcemia side effect safety signal, we point out this FDA statement: "We will communicate our final conclusions and recommendations when we have completed our review or have more information to share."

Of course, we will watch for the FDA's determination on possible regulatory action as regards this Prolia - hypocalcemia side effect -- for example, stronger drug safety warnings in a revised Prolia drug label -- and report on any such developments here on Drug Injury Watch.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Artificial Tears Vision Loss Case Reports Published in March 2023 Medical Journal

JAMA Ophthalmology Articles Give Details About Serious Eye Infections Due to Use of EzriCare Eye Drops

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Two recent JAMA Ophthalmology medical journal articles presented a detailed EzriCare case report about a patient with serious infection and vision loss associated with their use of artificial tears over-the-counter (OTC) eye drops.

From the first EzriCare case report medical journal article is "Pseudomonas aeruginosa Corneal Ulcer Associated With Artificial Tears Eye Drops":

A 72-year-old woman presented with vision loss in the left eye for 1 week. She reported use of over-the-counter (OTC) multiuse eye drops for bilateral dry eye syndrome.... Culture of left corneal scrapings grew extensively drug-resistant Pseudomonas aeruginosa, susceptible only to cefiderocol. Culture of her OTC EzriCare artificial tears grew comparable drug-resistant P aeruginosa.... At 2-month follow up, left-sided vision remained [light perception (LP)].

From the second EzriCare case report medical journal article is "Multidrug-Resistant Pseudomonas aeruginosa Keratitis Associated With Artificial Tear Use":

Corneal ulcers are typically associated with contact lens use, trauma, or chronic ocular surface disease and may cause irreversible blindness. The US Centers for Disease Control and Prevention (CDC) recently reported multidrug-resistant (MDR) Pseudomonas aeruginosa infections may be associated with use of EzriCare artificial tears after patients using this product developed MDR keratitis. We report a case of severe MDR P aeruginosa keratitis after EzriCare artificial tear use, with cultures of the corneal infiltrate and the patient’s EzriCare drops identifying the same strain of MDR P aeruginosa. [footnote omitted]

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EzriCare Artificial Tears

Delsam Pharma’s Artificial Tears

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This March 22, 2023, MedPage Today news item, "Case Reports Detail Vision Loss Linked to Recalled Artificial Tears", points out these observations found in the March 2023 JAMA Ophthalmology medical journal edition with the articles about these serious eye infections due to the use of EzriCare Artificial Tears eye drops:

The current outbreak of MDR P. aeruginosa "associated with the use of carboxymethylcellulose sodium (EzriCare) multidose preservative-free artificial tears may be a wake-up call for the field," the editorialists wrote, and "is a harsh reminder that all eye drops, including artificial tears, are medications with potential adverse effects, most commonly ocular but potentially systemic."...

Unlike with ophthalmic medications and devices, "manufactures of artificial tears are not required to perform clinical trials to market their products if they follow the guidelines in the FDA ophthalmic drug products for over-the-counter human use monograph, which may mean there is less oversight of their quality," the editorialists said. "The current situation is a tangible reminder that any type of eye drop can have untoward effects. We all need to be vigilant observing and reporting unexpected events."

Here is a list of our previous items concerning

• EzriCare Artificial Tears Associated With Eye Infections: February 2023 CDC Warnings Issued (February 2, 2023)
• Artificial Tears Eye Drops Recall Involving EzriCare and Delsam Pharma's Products in February 2023 (February 7, 2023)
• Delsam Pharma's Artificial Eye Ointment Recalled, Weeks After Artificial Tears Products Withdrawal (February 22, 2023)
• February Recalls of Eye Products Due to Bacterial Contamination Causing Serious Infections (March 1, 2023)

We have been investigating cases involving vision loss from an infection due to the use of these Global Pharma eye products: (1) Delsam Pharma’s Artificial Eye Ointment; (2) Delsam Pharma’s Artificial Tears; or, (3) EzriCare Artificial Tears. These possible drug injury lawsuits would be filed against Global Pharma, as the responsible company.

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.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

New Reporting System for Cases of Breast Implant-Associated Lymphoma: PROFILE Registry

March 2023 Miami Breast Cancer Conference: Updates on The Number of BIA-ALCL Deaths and Diagnoses

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In late March 2023, the FDA issued an update that announced the launch of a new reporting system for cases of breast implant-associated lymphoma. Earlier in March 2023 we received updates on the number of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) deaths and diagnoses in the US and worldwide.

From "UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication" we get the following information about the new reporting system for cases of breast implant-associated lymphoma:

As of March 22, 2023, health care providers can submit case reports of SCC, various lymphomas, and any other cancers in the capsule around breast implants to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) Registry, a collaborative effort between the American Society of Plastic Surgeons (ASPS), the Plastic Surgery Foundation (PSF), and FDA. Health care providers can continue to submit case reports of  Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)  to PROFILE as well.

The FDA reviews data from the PROFILE registry on an ongoing basis to gather all available information on cancers in the capsule around breast implants, and will keep the public informed on significant findings as new information becomes available.

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Next, we turn to this March 6, 2023, MedPage Today news report, "Cases of Breast Implant-Associated Lymphoma Continue to Accumulate", which provided updates on the number of BIA-ALCL deaths and diagnoses in the US and worldwide.

As of late 2022, the American Society of Plastic Surgeons global tracking network had accumulated 1,333 cases of BIA-ALCL worldwide and 35 associated deaths. The total included 402 cases and eight deaths in the U.S. The FDA has received information on 59 deaths, said Kelly K. Hunt, MD, of the University of Texas MD Anderson Cancer Center in Houston, during the Miami Breast Cancer Conference. 

"[BIA-ALCL] is associated with textured breast implants; it does not appear to be associated with smooth implants," she said. "It's felt to be the texturing process that results in this disease, but the pathogenesis is really not completely understood yet. There are a lot of different theories, but it's thought that production of inflammatory cytokines is involved."

We continue to handle cases of breast implant-associated lymphoma. As such, we have been monitoring the medical literature for updates on the number of BIA-ALCL deaths and diagnoses. Significant developments in the past have been put on the Breast Implants Lymphoma Cancer page of our law firm website, where we offer a Free Case Evaluation for women diagnosed with BIA-ALCL.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

February Recalls of Eye Products Due to Bacterial Contamination Causing Serious Infections

Timeline for EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, Delsam Pharma’s Artificial Eye Ointment

 

(Posted by Tom Lamb at Drug Injury Watch)

 

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

Here is the most recent information from the US Centers for Disease Control and Prevention (CDC) about case reports associated with bacterial contamination of these Global Pharma eye products:

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)

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EzriCare Artificial Tears

Delsam Pharma’s Artificial Tears

Delsam Pharma’s Artificial Eye Ointment

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Timeline:

• 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 bacterial contamination problem for these three Global Pharma eye products, EzriCare Artificial Tears, EzriCare Artificial Tears, and Delsam Pharma's Artificial Eye Ointment:

1. "EzriCare Artificial Tears Associated With Eye Infections: February 2023 CDC Warnings Issued" (2/2/23)
2. "Artificial Tears Eye Drops Recall Involving EzriCare and Delsam Pharma's Products in February 2023" (2/7/23)
3. "Delsam Pharma's Artificial Eye Ointment Recalled, Weeks After Artificial Tears Products Withdrawal" (2/22/23)

We are investigating cases involving hospitalization, death, or permanent vision loss from an infection due to the use of these Global Pharma eye products: (1) Delsam Pharma’s Artificial Eye Ointment; (2) Delsam Pharma’s Artificial Tears; or, (3) EzriCare Artificial Tears.

These cases are possible drug injury lawsuits that would be filed against Global Pharma.

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.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Delsam Pharma's Artificial Eye Ointment Recalled, Weeks After Artificial Tears Products Withdrawal

Updates About Bacterial Contamination Problem for These Over-The-Counter (OTC) Eye Products Given by FDA and CDC

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On February 21, 2023, and February 22, 2023, there were updates to this FDA document, "FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination", which was initially issued on February 2, 2023. A first update was about the Delsam Pharma’s Artificial Eye Ointment warning not to purchase or use this OTC eye product. A second update, one day later, was about the Delsam Pharma’s Artificial Eye Ointment recall by Global Pharma Healthcare Private Limited.

In addition, this CDC Healthcare-Associated Infections (HAIs) document, "Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears", was updated on or about February 21, 2023 (accessed 2/22/23) in order to provide an increased case count -- reported to be 58, up from 55 -- and to inform that there was a new case in one more state -- adding Illinois.  From that updated CDC document:

As of February 21, 2023, CDC, in partnership with state and local health departments, identified 58 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-five patients were linked to four healthcare facility clusters. One person has died and there have been 5 reports of vision loss. Dates of specimen collection were from May 2022 to January 2023. Isolates have been identified from clinical cultures of sputum or bronchial wash (13), cornea (12), urine (9), other nonsterile sources (4), and blood (2), and from rectal swabs (25) collected for surveillance; some patients had specimens collected from more than one anatomic site.

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EzriCare Artificial Tears

Delsam Pharma’s Artificial Tears

Delsam Pharma’s Artificial Eye Ointment

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Strictly Confidential, No Obligation.

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Here are two earlier articles we wrote 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.

1. "EzriCare Artificial Tears Associated With Eye Infections: February 2023 CDC Warnings Issued" (2/2/23)
2. "Artificial Tears Eye Drops Recall Involving EzriCare and Delsam Pharma's Products in February 2023" (2/7/23)

We are investigating cases involving hospitalization, death, or permanent vision loss from an eye infection due to the use of Delsam Pharma’s Artificial Eye Ointment, Delsam Pharma’s Artificial Tears, or EzriCare Artificial Tears lubricant eye drops. These cases are possible drug injury lawsuits that would be filed against Global Pharma.

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.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Artificial Tears Eye Drops Recall Involving EzriCare and Delsam Pharma's Products in February 2023

Serious Infections Causing Vision Loss Have Been Linked to the Use of EzriCare Artificial Tears Lubricant Eye Drops

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Today we pick up where our article from last week "EzriCare Artificial Tears Associated With Eye Infections: February 2023 CDC Warnings Issued" ended --  that is, we will be monitoring the CDC and FDA for further developments -- with news about an artificial tears eye drops recall involving EzriCare and Delsam Pharma’s Artificial Tears over-the-counter (OTC) products.

From this February 2, 2023 document, "FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination":

Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.

FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections.

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EzriCare Artificial Tears

Delsam Pharma’s Artificial Tears

Delsam Pharma’s Artificial Eye Ointment

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Strictly Confidential, No Obligation.

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This CDC Outbreak and Patient Notifications article, "Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears", reported that as of January 31, 2023, those 55 patients were located in these 12 states:

• California
• Colorado
• Connecticut
• Florida
• New Jersey
• New Mexico
• New York
• Nevada
• Texas
• Utah
• Washington
• Wisconsin

The CDC article also provided in-depth information about a rare type of drug-resistant infection these patients had been diagnosed with after using EzriCare Artificial Tears lubricant eye drops, "VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa".

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 artificial tears eye drops 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".

Importantly, this Global Pharma Healthcare recall announcement includes a "Product Photos" part at the end which will help people with identifying the particular over-the-counter (OTC) lubricant eye drops that are part of this February 2023 recall involving EzriCare and Delsam Pharma’s Artificial Tears products.

We are investigating Delsam Pharma’s Artificial Tears and EzriCare Artificial Tears lubricant eye drops cases involving hospitalization, death, or permanent vision loss from an eye infection as possible drug injury lawsuits that would be filed against Global Pharma Healthcare.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

EzriCare Artificial Tears Associated With Eye Infections: February 2023 CDC Warnings Issued

CDC Recommends Patients Stop Using EzriCare Artificial Tears Products Pending Additional Guidance For These OTC Eye Drops

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On February 1, 2023, the US Centers for Disease Control and Prevention (CDC) issued a warning about an over-the-counter (OTC) eye drops product, EzriCare Artificial Tears, being associated with serious eye infections in patients in various states during recent months. For a quick overview of these eye infections linked to EzriCare Artificial Tears see this CDC document, "Health Alert Network (HAN) No. 485 – Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa associated with Artificial Tears".

Here is the "Summary" section of that February 1, 2023, CDC Health Advisory:

The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 states. Most patients reported using artificial tears. Patients reported more than 10 different brands of artificial tears, and some patients used multiple brands. The majority of patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles. CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states. Patients and healthcare providers should immediately discontinue using EzriCare artificial tears pending additional guidance from CDC and the Food and Drug Administration (FDA).

__________________________________________________________________

EzriCare Artificial Tears

Delsam Pharma’s Artificial Tears

Delsam Pharma’s Artificial Eye Ointment

Free Case Evaluation

Strictly Confidential, No Obligation.

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The CDC warnings for these eye infections linked to EzriCare Artificial Tears include the following, taken from a section titled "Recommendations for the Public":

• 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.

More detailed information about the eye infections linked to EzriCare Artificial Tears is presented in this CDC Outbreak and Patient Notifications article, "Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears". In that CDC document, there is a "Current Update" part from which we get the following three facts:

1. 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. Thirty-five patients were linked to four healthcare facility clusters. Dates of specimen collection were from May 2022 to January 2023.
2. Most patients reported using artificial tears. Patients reported over 10 different brands of artificial tears and some patients used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported. This was the only common artificial tears product identified across the four healthcare facility clusters.
3. Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing.

We will be monitoring the CDC as well as the FDA for further guidance, information, and warnings related to these serious eye infections linked to EzriCare Artificial Tears.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Valtrex Associated With Serious Skin Reaction DRESS Side Effect That Can Be Fatal, Says Health Canada

Canadian Product Monograph for Valtrex Now Warns About Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Valtrex (valacyclovir) is a long-established treatment for cold sores, genital herpes, and herpes zoster, having been initially approved by the FDA in 1995. 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 drug side effect.

In more detail, from the Valtrex part of the "New health product safety information" section of this December 2022 Health Canada document:

• [Drug reaction with eosinophilia and systemic symptoms (DRESS)] has been reported in association with [Valtrex (valacyclovir)] treatment. DRESS is a serious skin reaction that may affect one or more organs and can be life-threatening or fatal.

• Patients should be monitored closely for skin reactions and advised of the signs and symptoms of DRESS, including fever, severe rash, peeling skin, facial edema, lymphadenopathy, flu-like feeling, jaundice, dyspnea, dry cough, chest pain or discomfort, dehydration, and eosinophilia.

• If signs and symptoms suggestive of DRESS appear, [Valtrex (valacyclovir)] should be withdrawn immediately and an alternative treatment considered, as appropriate.

• If a patient has developed DRESS with the use of [Valtrex (valacyclovir)], treatment with valacyclovir must not be restarted in this patient at any time.

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.

In comparison, 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 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).

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)