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- Why are eye drops withdrawn from the market?
- What eye drops should I avoid?
- A full list of currently retired brands
Update (08/25/23):The Food and Drug Administration (FDA)urges consumersImmediately stop using two brands of eye drops sold online:dr. Bernes MSM drops a solution at 5%YLightEyez MSM Eye Drops Eye Repair— due to bacterial and/or fungal contamination. In addition, these eye drops were also found to contain the active ingredient methylsulfonylmethane (MSM), which is not approved for use in any legally marketed eye drugs or products in the United States, according to the FDA.
To date, the FDA has received no reports of adverse events associated with the use of these products. However, you should contact your doctor or other healthcare professional immediately if you experience the following common signs of an eye infection:
- Yellow, green, or clear discharge from the eye.
- eye pain or discomfort
- Redness of the eye or eyelid
- sensation of something in the eye (foreign body sensation)
- Increased sensitivity to light.
- blurry vision
FDA testing found LightEye's MSM Eye Drops-Eye Repair to be contaminated with four different types of bacteria, including Pseudomonas aeruginosa, the strain responsible for recalls and associated infection outbreaks in March and May of this year ( more on this below). ). ; Dr. Bern's 5 percent MSM drop solution was found to have bacterial and fungal contamination, both of which have the potential to cause symptoms or infections that affect vision.
If you have any of these products in your medicine cabinet, the FDA recommends throwing them away immediately.according to your recommendationsfor the safe disposal of unused or expired medicines; This normally means that the affected products are delivered to a local retailer.secure disposal or collection point for medicines,or follow any disposal instructions that may be included in the product instructions for use.
dr. Berne has "verbally agreed" to recall the contaminated drops, the FDA says, and a pop-up notice on the website offers a refund, stating: "I perform my own testing on all MSM products using samples at an outside laboratory." and we will post these results here on Monday. If you have MSM 5% Lot #6786, stop using it.” The FDA said it has not received a response from LightEyez at this time.
Update (05/19/23):The Centers for Disease Control and Prevention (CDC)has issued an updateon the outbreak of the bacterium Pseudomonas aeruginosa associated with the use of artificial tears. As of May 15, 81 patients (up from 68 in March) were infected with VIM-GES-CRPA, a rare strain of drug-resistant bacteria..
Fourteen people were blinded and four had their eyeballs surgically removed. The number of deaths related to the outbreak has risen from three to four.
The CDC anticipates that there will be more cases of infection and, although the products have been recalled, they say that those who have used EzriCare or Delsam Pharma artificial tears or Delsam Pharma artificial eye ointment and have signs or symptoms of an eye infection, seek medical attention. immediately.
According to the CDC, symptoms of an eye infection can include:
- Yellow, green, or clear discharge from the eye.
- eye pain or discomfort
- Redness of the eye or eyelid
- sensation of something in the eye (foreign body sensation)
- Increased sensitivity to light.
- blurry vision
Original (28.03.23):Federal health investigators are finding out more about the outbreak of an unusual strain of bacteria calledPseudomonas aeruginosa, which is increasingly due to eye drops. The bacteria can cause debilitating eye infections that can lead to permanent blindness or even complete surgical removal of the eye, as has been the case for at least some time.a woman in floridarecently.
With officials inCenters for Disease Control and Prevention (CDC)productionfirst warningsGiven the increase in bacterial infections in January 2023, CDC officials have almost determined70 patients in 16 different states have drug-resistant infections and multiple symptoms. There have been a total of three deaths specifically linked to eye drop exposure, and federal investigators say they may learn more illnesses soon.
Earlier this year there were at least two clear recalls related to possible bacterial contamination.CDC officials indicatethat EzriCare artificial tears have been the most cited in most infections reported to date. "Unopened bottles of EzriCare artificial tears are currently being tested to assess whether contamination may have occurred during manufacturing," the current study states.CDC reports.
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🚨 Multistate outbreak: Infections related to artificial tear products. If you have EzriCare or Delsam Pharma artificial tear products, stop using them and seek immediate medical attention if you develop symptoms of an eye infection. Learn more:https://t.co/qzeGLW1QF1 pic.twitter.com/7i9BCLZgMd
– CDC (@CDCgov)February 6, 2023
But CDC officials have also indicated that they are still actively investigating the source of the bacterial contamination; there is a possibility of more recalls in the future as healthcare providers learn more about those affected by the contaminated eye drops. "Patients reported using more than ten different brands of artificial tears, with some patients using multiple brands," the CDC said.
Read on for an up-to-date list of recalled eye drops and bacterial eye infection symptoms to look out for.This article will be updated with more information on current recalls when it becomes available.
Why are eye drops withdrawn from the market?
RespectivelyCDC Materials, the bacteriaPseudomonas aeruginosait occurs naturally in the world around us; usually in water, soil, and human waste. In most cases, this particular strain of bacteria is resistant to antibiotic treatments and can prove fatal to those in particular.weakened immune systemand those receiving care in hospitals and clinics. In addition to the three deaths attributed to contaminated eye drops,CNN reportsFederal officials have said eight patients have gone blind as a result of the outbreak. Four other patients had their eyeballs surgically removed to prevent further side effects or more serious symptoms.
It's currently unclear how these bacteria got into the eye drops, but artificial tears are more likely to become contaminated during the manufacturing process and not be sterilized when the solutions are packaged and released to the public.
As recalls spread across the country,So far, cases have been registered in 16 states.: Kalifornien, Colorado, Connecticut, Florida, Illinois, Nevada, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, South Dakota, Texas, Utah, Washington, and Wisconsin.
Health Care Providers at the University of California Davis Eye Centerpublished materialsThis suggests that this particular bacterium affects the eye by specifically destroying the cornea. Although this particular strain of bacteria has not previously been associated with eye drops,CDC officials notedHeP. aeruginosaIt caused more than 2,700 deaths in 2017. In the past, infections were caused by sepsis (in the blood) or respiratory tract.and urinary tract infections, with more than 33,000 cases registered in the same year.
More eye drop recalls are making headlines this month, but it's important to notethey arenospecifically related to itassociated with bacterial infectionsPseudomonas aeruginosa. Read on to find out which eye drops are being recalled and why.
What eye drops should I avoid?
officials inFood and Drug Administration (FDA)have indicated that not all recalls related to eye drops currently underway are explicitly linked to thisPseudomonas aeruginosa. In early February, two different eye drops directly linked to the risk of bacterial infection were withdrawn from the market: EzriCare and Delsam Pharma brand artificial tear lubricating eye drops, manufactured byGlobal pharmaceutical healthcare.
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Global Pharma Healthcare is conducting a voluntary nationwide recall of artificial tear fluid eye drops due to possible contamination.https://t.co/e5xmXv4DP8 pic.twitter.com/tahNitvQKL
- US FDA Recalls (@FDArecalls)February 3, 2023
However, this is not clear due to the FDA recall announcement.WhenAlthough these artificial tears were originally manufactured, officials said they were likely sold and distributed online. Affected customers should verify the products affected by these recalls by checking the UPC codes on the outer packaging of the eye drops, which the FDA has detailed.recall announcements.
Symptoms associated with bacterial eye infections can include a wide rangediscomfort and pain related to the eyes, including yellow, green, or clear discharge; redness of the eye or eyelid; increased sensitivity to light; constantly blurred vision; as well as unrelenting irritation on the inside of the eye that feels like an itchand CDC officials. And the symptoms caused by this particular bacterial infection can usually appear within 12 to 24 hours.published research.
Anyone experiencing symptoms who has recently used any of the brand name eye drops.you should see an ambulance immediately. Serious eye infections are often ignored or misdiagnosed without clinical care and, if left untreated, can lead to life-threatening complications, especially in drug-resistant strains of bacteria like the one identified by CDC officials.
There are a few other eye drops and another eye ointment that were withdrawn from the market at the same time as the above two products, but not due to the same potential bacterial load. We summarize this information below.
A full list of currently retired brands
Two eye drop products have been specifically associated with the current version.Pseudomonas aeruginosaOutbreak. However, consumers may be confused by three other recalled eye care products that officials are currently referring to, as these products have yet to be linked to the current 68 cases of bacterial infections in the US. .us
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– CBS Mornings (@CBSMornings)March 23, 2023According to the CDC, at least three people have died from a rare bacterium found in recalled eye drops sold by Ezricare and Delsam Pharma.
There have also been cases of vision loss and some people have even lost an eye.pic.twitter.com/N23dTPKO7o
Here's a complete list of the eye drops being recalled and more information on why federal regulators put them on the recall lists in the first place:
- EzriCare Artificial Tear Lubricant Eye Drops:Respectivelygo CDCThis product has been implicated as a common factor in 37 of the 68 cases registered so far. Potentially contaminated eye drops can be identified by the following manufacturer codes on the package: NDC 79503-0101-15 and UPC 3 79503 10115 7.
- Delsam Pharma Lubricant Eye Drops Artificial Tears: This product is also related to current bacterial infections and is also manufactured by Global Pharma Healthcare. Recalled products can be identified by packaging codes NDC 72570-121-15 and UPC 3 72570 12115-8.
- Delsam Pharma Artificial Eye Ointment:Delsam topical ointment, made by the same manufacturer, has not been linked to the current cases, but is being withdrawn from the market due to "possible microbial contamination," according to the CDC. While not technically an eye drop product, the equivalent ointment tubes (applied to the skin near the eye) can be identified by NDC 72570-122-35 and UPC 3 72570 12235 3.
- Clear Eyes Once Daily Itch Relief from Eye Allergies:There is no official link to the cases of bacterial infection identified by the CDC.The FDA has statedThe manufacturer of this brand, Teva Pharmaceuticals, is recalling certain batches of this popular eye drop due to "failed contamination tests." This recall includes more than 700,000 bottles with expiration dates through late 2023 and early 2024 in the following lots: Lot 114349, Lot 117396, Lot 0120128, Lot 114371, and Lot 123781. Accordingly The Miami Herald,Buyers are encouraged to return affected eye drops to a retailer for a full refund. Teva Pharmaceuticals has established a call-back hotline at 888-838-2872 for buyers with additional questions.
- Purely calming 15% MSM drops:AOfficial FDA Recall Noticeadvises that this product has not been associated with disease or injury associated with Pseudomonas aeruginosa. The manufacturers have advised that two batches of this product may not be sterilized. These products are manufactured in 1 ounce and 0.5 ounce sizes and can be identified by lot codes and UPC information. Affected products have 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 small subset of these eye drops, a specialized tool for people with glaucoma or ocular hypertension, are being voluntarily recalled because faulty caps can result in non-sterile solutions that can cause similar symptoms. those of the manufacturerAn FDA recall points this out.The affected drops were distributed nationwide between April 2022 and February 2023, with an expiration date that extends to 2024. They can be identified by the NDC numbers on the box and packaging labels, including 60505- 0564-1, 60505-0564-2 and 60505-0564-3.
We will continue to update this story with additional recalls and updated information as it becomes available.
Zee Krstic
health editor
Zee Krstic is health editor ofGood Housekeeping, where he covers health and nutrition news, decodes diet and fitness trends, and reviews the best wellness products. Before joining GH in 2019, Zee was a contributing editor.kitchen lightHe continues to develop his understanding of integrative health by collaborating with leading academic experts and clinical care providers. She has written about food and food forTime, among other things.
Alyssa Jung
chief editor
Alyssa is a senior editor at Hearst Health Newsroom, for which she is the author of research-based health content.prevention,Good HousekeepingYwomen's Daysince 2017. She has more than 13 years of reporting and editing experience, and previously served as a research director atReader's Digest, where he was responsible for the health section of the website and for the edition of health content for the printed magazine. She has also written for Chowhound, HealthiNation.com, Huffington Post, and more.