What You Need To Know About The Flurry Of Eye Drop Recalls

The Food and Drug Administration recently announced recalls of several eye drop brands linked to an outbreak of drug-resistant bacteria responsible for three deaths and multiple cases of people going blind.

Friday, March 24th 2023, 10:28 am

By: CBS News


The Food and Drug Administration recently announced recalls of several eye drop brands linked to an outbreak of drug-resistant bacteria responsible for three deaths and multiple cases of people going blind.

Eight people also have lost their vision and four have had their eyeballs removed, according to the Centers for Disease Control and Prevention. As of March 14, 68 patients across 16 states were found to have contracted the bacteria, known as Pseudomonas aeruginosa.

Millions of consumers use nonprescription, over-the-counter drops daily as a remedy for dryness, irritation and other mild eye conditions. But the flurry of recalls is leaving some regular users of the products wondering, are they safe? Here's what you should know.

Which brands of drops have been recalled?

EzriCare and Delsam Pharma "Artificial Tears Lubricant Eye Drops." Global Pharma Healthcare on February 2 recalled all lots of its EzriCare and Delsam Pharma brands of "Artificial Tears Lubricant Eye Drops," which it said could be contaminated with bacteria.

The recall came after the Centers for Disease Control and Prevention (CDC) began an investigation of a cluster of multistate bacterial infections it believed were associated with the tear drops. At the time of the recall, there were 55 reports of adverse reactions to the drops, including eye infections, permanent vision loss and one death from a bloodstream infection.

Global Pharma Healthcare said in a a statement that consumers who use the contaminated eye drops could go blind.

Customers have been advised to immediately stop using the drops.

Delsam Pharma "Artificial Eye Ointment." Global Pharma on February 24 also recalled one batch of a product distributed by Delsam Pharma,"Artificial Eye Ointment," again due to possible microbial contamination.

The company said that using the contaminated ointment could lead to infections that cause blindness, though it has not received any reports of injuries related to the product.

Apotex "Brimonidine Tartrate Ophthalmic Solution, 0.15%." Another manufacturer, Apotex, on March 1 recalled six lots of its own brand of glaucoma drops, called "Brimonidine Tartrate Ophthalmic Solution, 0.15%," which is for patients with open-angle glaucoma or ocular hypertension.

The company said it initiated the recall "out of an abundance of caution" over concerns that cracks in some of the units' caps could compromise the drops' sterility and lead to infection.

An Apotex spokesperson said the company has observed four bottles with cracked caps and that there have been no reports of negative health outcomes related to the product.

Pharmedica "Purely Soothing, 15% MSM Drops." Pharmaceutical firm Pharmedica USA on March recalled two lots of "Purely Soothing, 15% MSM Drops," also over sterility concerns.

Pharmedica warned that patients who use the contaminated eye drops can risk going blind, but the company said it has not received any reports of infection or illness related to its product.

How were problems with eye drops first detected?

According to the Associated Press, a patient in Los Angeles County, California, who had seen an ophthalmologist in the spring of 2022 developed an eye infection. Local health officials identified several more cases in subsequent months, with patients reporting eyes inflamed with heavy yellow pus that obscured most of the pupil.

The hospital that reported the first infection determined it was caused by the Pseudomonas aeruginosa bacteria, which can cause infections in the blood, lungs or other parts of the body. The institution also determined the bacteria is resistant to many antibiotics.

Over the course of the year, other states received multiple reports of drug-resistant Pseudomonas, including a report of a Washington man who died after suffering bloodstream infection linked to over-the-counter eye drops.

In January, testing confirmed the Florida cases were caused by the same bacteria strain as cases in California, Connecticut and Utah. On January 20, the CDC told doctors to avoid recommending the EzriCare product.

What are the risks?

As of March 14, the CDC had identified 68 patients across 16 states who had been infected infected by Pseudomonas aeruginosa. Health officials said the outbreak is linked to using artificial tears. Three people have died and eight patients reported vision loss, according to the agency.

The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands.

Eye drops can cause infections in other parts of the body because the eye connects to the nasal cavity through the tear ducts and germs can move from the nasal cavity into the lungs.

Pseudomonas aeruginosa, which occurs naturally in the environment, can spread to humans who are exposed to contaminated water or soil. Pseudomonas aeruginosa can spread from one person to another through contaminated hands, equipment or surfaces, according to the CDC. Drug-resistant strains of the bacteria cause more than 30,000 infections annually among hospitalized patients in the U.S. and more than 2,500 deaths.

What if I use the recalled drops?

The CDC and FDA urge patients to immediately stop using the recalled eye drops — even if they haven't experienced an adverse reaction.

Patients who have previously used potentially unsafe products should contact their doctors and ask for a safe substitute.

When should I see a doctor for testing or treatment?

Patients who have used recalled eye drops should assess if they have any of the following symptoms commonly associated with eye infections:

Discharge from the eye

Eye pain or discomfort

Redness of the eye or eyelid

Feeling something in the eye

Increased sensitivity to light

Blurry vision

Patients with any signs of infection should immediately contact their health care provider for evaluation and treatment. Patients without symptoms do not need to undergo testing.

Are my eye drops safe?

Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus.

"There's not much testing of safety on any of these things, so when something comes out it's because there were complaints, or in this case a drug-resistant bacteria was linked to a bunch of cases," he told CBS MoneyWatch.

As far as products and brands that remain on the market and are not under recall, he advised patients to "stick to the big brands that you trust." He also urged consumers to consider whether they really need to use eye drops.

"Ask your eye doctor whether you really need them," Agus said. "If we don't really need something, then we probably shouldn't be using it. If it's not a real problem — maybe we have a tiny bit of dryness — we probably shouldn't be putting something into our eye," he said.

CBS News' Alexander Tin and the Associated Press contributed to this report.

First published on March 8, 2023 / 5:32 PM

© 2023 CBS Interactive Inc. All Rights Reserved.

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