CDC Reports Another Death Linked to Recalled Eye Drops
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Update (5/19/23): The Centers for Disease Control and Prevention (CDC) has issued an update about the outbreak of Pseudomonas aeruginosa bacteria associated with the use of artificial tears. As of May 15, 81 patients (up from 68 in March) have been infected with with VIM-GES-CRPA, a rare strain of drug-resistant bacteria.
Fourteen people have been blinded and four have had their eyeballs surgically removed. The number of deaths linked to the outbreak has rise from three to four.
The CDC expects more cases of infections to arise, and while the products have been recalled, it says that those who have used EzriCare or Delsam Pharma’s artificial tears or Delsam Pharma’s artificial eye ointment and who have signs or symptoms of an eye infection should seek medical care immediately.
Per the CDC, eye infection symptoms may include:
Yellow, green or clear discharge from the eye
Eye pain or discomfort
Redness of the eye or eyelid
Feeling of something in your eye (foreign body sensation)
Increased sensitivity to light
Original (3/28/23): Federal health investigators are uncovering more about an outbreak of an uncommon strain of bacteria known as Pseudomonas aeruginosa, which is increasingly being traced back to eye drops. The bacteria can trigger debilitating eye infections that may cause permanent blindness, or even surgical eye removal altogether, which has been the case for at least one woman in Florida recently.
With officials at the Centers for Disease Control and Prevention (CDC) issuing first warnings on the uptick in bacterial infections back in January 2023, CDC agents have now identified nearly 70 patients in 16 different states that have suffered drug-resistant infections and multiple symptoms. There have been a total of three deaths linked back to exposure through eye drops specifically, with federal investigators indicating that they may soon learn of additional illnesses.
Earlier this year, there were at least two distinct recalls that were linked to potential bacterial contamination, with CDC agents indicating that EzriCare Artificial Tears were most commonly cited in the bulk of reported infections thus far. "Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating whether contamination may have occurred during manufacturing," per current CDC reports.
🚨 Multistate Outbreak: Infections Associated with Artificial Tears Products. If you have EzriCare or Delsam Pharma Artificial Tears Products, stop using them and seek medical care immediately if symptoms of an eye infection occur. Learn more: https://t.co/qzeGLW1QF1 pic.twitter.com/7i9BCLZgMd
— CDC (@CDCgov) February 6, 2023
But CDC officials have also indicated they are still actively investigating the source of bacterial contamination — there's a possibility that more recalls may take place in the future as healthcare providers learn more about those impacted by tainted eye drops. "Patients reported over 10 different brands of artificial tears and some patients used multiple brands," the CDC indicated.
Read on to learn more about a current list of recalled eye drops and symptoms of bacterial eye infections to consider. This article will be updated with more information about current recalls as it becomes available.
Why are eye drops being recalled?
According to CDC materials, the bacteria Pseudomonas aeruginosa is naturally found in the world around us; usually in water, soil and human waste. More often than not, this particular strain of bacteria is resistant to antibiotic treatments and can especially prove deadly for those with weakened immune systems and those who are receiving care in hospital and clinic settings. In addition to the three deaths that are being traced back to tainted eye drops, CNN reports that federal officials have indicated that eight patients have developed blindness due to the outbreak. An additional four have had to have their eyeballs surgically removed to prevent further side effects or more serious symptoms.
It's currently unclear how this bacteria ended up in eye drops, but it's more likely that artificial tears are being contaminated during the manufacturing process — and aren't sterile when solutions are packaged and released to the public.
While recalls are being implemented across the nation, cases thus far have been recorded in 16 states: California, Colorado, Connecticut, Florida, Illinois, Nevada, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin.
Healthcare providers at the University of California, Davis's Eye Center published materials that suggest that this particular bacteria impacts the eye by destroying the cornea specifically. While this specific strain of bacteria has not been linked to eye drops previously, CDC officials noted that P. aeruginosa caused upwards of 2,700 deaths in 2017 specifically. Historically, it has caused infections through sepsis (in the blood) or respiratory and urinary tract infections, with upwards of 33,000 recorded cases in the same year.
Additional eye drop recalls are making headlines this month, but it's important to note that they are not expressly related to bacterial infections being linked to Pseudomonas aeruginosa. Read on to learn which eye drops are being recalled and why.
What eye drops should I avoid?
Officials at the Food and Drug Administration (FDA) have indicated that not every recall currently in place involving eye drops are explicitly linked to Pseudomonas aeruginosa. Earlier in February, two distinct eye drop products were recalled and have been directly linked to a risk of bacterial infection — Artificial Tears Lubricant Eye Drops branded by EzriCare and Delsam Pharma, manufactured by Global Pharma Healthcare.
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination https://t.co/e5xmXv4DP8 pic.twitter.com/tahNitvQKL
— U.S. FDA Recalls (@FDArecalls) February 3, 2023
While it's unclear based on the FDA's recall announcement when these artificial tears were initially manufactured, officials did indicate that these were likely sold and distributed online. Affected customers are being instructed to verify products implicated in these recalls by checking UPC codes on the eye drop's exterior packaging, which has been detailed in FDA recall announcements.
Symptoms associated with bacterial eye infections can include a wide array of eye-related discomfort and pain, including yellow, green or clear discharge; redness of the eye or eyelid; increased light sensitivity; consistent blurry vision; as well as an unshakable inner-eye irritation that feels like an itch, according to CDC officials. And symptoms triggered by this particular bacterial infection may start presenting usually within 12 to 24 hours, per published research.
Anyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. Severe eye infections may often go ignored or misdiagnosed without clinical care, and left untreated, could cause life-threatening complications, especially with drug-resistant strains of bacteria like the one being traced by CDC officials.
There are a few other eye drops and one other eye ointment that have been concurrently recalled in the same period as the two products above — but not due to the same potential bacterial exposure. We're recapping that information below.
A full list of current recalled brands
Two specific eye drop products have been expressly linked to the current Pseudomonas aeruginosa outbreak. But consumers may be confused about three other recalled eye-care products that officials are referring to currently, as these products have yet to be linked to the 68 current cases of bacterial infections logged across the U.S.
At least three people have died due to a rare bacteria found in recalled eye drops, distributed by Ezricare and Delsam Pharma, according to the CDC.
There have also been cases of vision loss – and some people have even lost an eye. pic.twitter.com/N23dTPKO7o
— CBS Mornings (@CBSMornings) March 23, 2023
Here's a full list of recalled eye drops and more context on why federal regulators have placed these on recall lists in the first place:
EzriCare Artificial Tears Lubricant Eye Drops: According to the CDC, this product was implicated as a common factor in 37 of the 68 logged cases so far. Potentially tainted eye drops can be identified with the following manufacturing codes listed on its packaging; NDC 79503-0101-15 and UPC 3 79503 10115 7.
Delsam Pharma Artificial Tears Lubricant Eye Drops: Also linked to current bacterial infections, this product is also manufactured by Global Pharma Healthcare. Recalled products can be identified using packaging codes NDC 72570-121-15 and UPC 3 72570 12115 8.
Delsam Pharma Artificial Eye Ointment: Produced by the same manufacturer, Delsam's topical ointment hasn't been linked to current cases as recorded by the CDC, but is being recalled due to "possible microbial contamination." While it's not technically an eye drop product, implicated tubes of ointment (which is used on skin in proximity to the eye) can be identified with the NDC 72570-122-35 and UPC code 3 72570 12235 3.
Clear Eyes Once Daily, Eye Allergy Itch Relief: Not officially linked to any bacterial infection cases being traced by the CDC, the FDA has indicated this brand's manufacturer, Teva Pharmaceuticals, is recalling certain batches of this popular eye drop product due to a "failed impurities" test. This recall includes over 700,000 bottles with expiration dates reaching into late 2023 and early 2024 in the following lots: Lot 114349, Lot 117396, Lot 0120128, Lot 114371, and Lot 123781. According to the Miami Herald, shoppers are being encouraged to return implicated eye drops to a point of purchase for a full refund. Teva Pharmaceuticals have set up a recall hotline at 888-838-2872 for shoppers who have additional questions.
Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this product has yet to be linked to any illnesses or injuries related to Pseudomonas aeruginosa. Its manufacturers have indicated that two lots of this product may not be sterile. These products, made in 1oz and .5oz sizes, can be identified using lot codes and UPC information. Implicated products display the following identifiers: LOT#: 2203PS01, UPC 7 31034 91379 9; and LOT#: 1808051, UPC 7 31034 91382 9.
Brimonidine Tartrate Ophthalmic Solution, 0.15%: A special tool designated for those with glaucoma or ocular hypertension, a small subset of these eye drops are being voluntarily recalled as faulty caps may lead to unsterile solutions that may cause similar symptoms. The manufacturer's FDA recall indicates affected drops were distributed between April 2022 and February 2023 across the nation, with expiration dates that range into 2024. They can be identified by NDC numbers listed on the carton and packaging labels, which include 60505-0564-1, 60505-0564-2 and 60505-0564-3.
We'll continue to update this story with additional recalls and current information as it becomes available.
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