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