Reminder of killer eye drops: what you need to know and the brands involved
A spate of US deaths and blindness caused by contaminated eye drops has sparked panic across the country.
Three Americans have died, eight have lost sight and four people had to have their eyeballs removed after becoming infected with a rare drug-resistant strain of bacteria called Pseudomonas aeruginosa.
The bacteria has been found lurking in EzriCare and Delsam Pharma eye drops from Indian manufacturer Global Pharma, which have been recalled as health officials investigate.
Most patients reported using 10 different brands of artificial tears, but EzriCare Artificial Tears, an over-the-counter product with no preservatives, was the most reported brand.
What do we know about the outbreak?
The Centers for Disease Control and Prevention (CDC) says 68 people in 16 states were diagnosed with infections from the bacteria in EzriCare, which has caused three deaths and caused eight people to lose their sight, and four people who had to have their eyeballs removed
As of March 14, 68 patients in 16 states are reported to have been infected with this “rare strain” of Pseudomonas aeruginosa, according to the Centers for Disease Control and Prevention (CDC).
Which brands of eye drops have been recalled?
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) first issued a warning to the public in January against the use of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears.
Last month, the manufacturer Global Pharma recalled the drops sold at major drugstores across the country, including Walmart, Target and CVS, and on Amazon.
It issued a second memory later in February of Delsam’s artificial eye ointment “because of possible microbial contamination.”
A possible cause of the contamination is a lack of preservatives in the artificial tears of EzriCare and Delsam Pharma.
The FDA said the company failed to adequately test its products for bacterial contamination and packaged them without adequate preservatives, a guarantee for products to prevent the growth of bacteria in the event of contamination.
Earlier this month, two other companies recalled some of their products. Apotex from Florida voluntarily recalled six lots of the prescription brimonidine tartrate ophthalmic solution, 0.15 percent on March 1 because at least four caps showed cracks, endangering their infertility.
And on March 3, Pharmadica recalled it’s purely smoothing 15 percent MSM drops “because of non-sterility.”
What Are the Symptoms of an Eye Infection?
There are plenty of signs of an eye infection to watch out for. Common symptoms include yellow, green, or clear discharge from the eye, blurred vision, discomfort or the feeling that something is in the eye, sensitivity to light, and redness of the eye or eyelid.
A recent case study published this week in JAMA Ophthalmology reported on a 72-year-old woman who suffered loss of vision in the left eye for a week after using EzriCare artificial tears for her bilateral dry eye syndrome.
Another case study involved a 72-year-old man who developed significant vision loss due to a corneal infection. It later improved, but he still has vision problems. He had no previous eye problems, but after using EzriCare artificial tears for dry eyes, he was in severe pain.
In one case, a 72-year-old woman lost vision in her left eye after using EzriCare artificial tears for about a week. She was hospitalized for three weeks and underwent IV antibiotics, antibiotic eye drops and multiple surgical procedures
In another case, a 72-year-old man had a serious infection left behind in his eye. Although it had improved a month later, he still had vision problems
It was later discovered at a Miami eye hospital that the man had multidrug-resistant Pseudomonas aeruginosa keratitis. Doctors later found that cultures of the man’s cornea and the EzriCare bottle grew the same strain of multidrug-resistant Pseudomonas.
In some extreme cases, the infection can spread elsewhere in the body, including into the bloodstream. Three people have died of an infection, eight people have lost their sight and four people have had their eyeballs surgically removed.
Are eye drops safe?
The answer to this question affects more than 117 million Americans who use eye drops and eye washes for a variety of reasons, from dry eye syndrome to glaucoma. The risk to the public seems generally low and even lower for people using preservative eye drops.
Dr. Thomas Steinemann, clinical spokesman for the American Academy of Ophthalmology, told CNN, “There are millions and millions of people who use eye drops safely and successfully in the United States for a variety of reasons.
“I want to emphasize that for the average eye drop user, there are probably very few concerns and they should not stop using their eye medications or even their over the counter preparations… Most drops on the market contain preservatives that would make the eye drops counteract. that threat [of bacteria multiplying and spreading in the eye.]’
What went wrong?
The CDC is continuing its investigation of the matter with the FDA and state governments.
The 16 states where patients have been infected are California, Colorado, Connecticut, Florida, Illinois, North Carolina, New Jersey, New Mexico, New York, Nevada, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin.
The CDC said it found the drug-resistant strain of P. aeruginosa in open bottles of the EzriCare drops that researchers collected from patients both with and without infections as of May 2022. The agency will also continue to test unopened bottles.
The agency still doesn’t know if the drops were contaminated during the manufacturing process or after they left the factory, possibly from cracked caps that let in dangerous bacteria.
Is this a broader problem?
The current outbreak could be symptomatic of a larger manufacturing problem at India-based eye drop maker Global Pharma Healthcare Private Limited.
The FDA added the company to its list of banned imports last month. citing several violations of manufacturing regulationsincluding a “lack of proper controls over sealed packages” and a “lack of appropriate microbial testing”.
The incident stemming from Global Pharma comes just a few months after a government commission in the Gambia slammed India-based drugmaker Maiden Pharmaceuticals for its role in the deaths of 70 children from acute kidney injury.
Public health researchers linked the tragic kidney injuries to Maiden’s contaminated cough syrups, which the World Health Organization concluded contain toxic levels of diethylene and ethylene glycol and should be withdrawn. The drugs were pulled from shelves and Maiden’s manufacturing license in India was suspended.
Meanwhile, last year in Uzbekistan, at least 19 children died after consuming cough syrup from India-based Marion Biotech. Uzbekistan’s health ministry said the syrup was contaminated with a toxic substance, ethylene glycol, and was administered in doses higher than the standard dose for children.
A separate but equally important growing global problem is the emergence of treatment-resistant bacterial infections caused by a number of causes, including overuse and overprescription, a lack of new antibiotics coming to market, and the uptake of the antibiotics used for agriculture and Cattle breeding.
A growing list of infections, such as tuberculosis, pneumonia, septicemia, gonorrhea and foodborne illness, are becoming increasingly difficult, if not impossible, to treat as antibiotics become less effective.
Many public health organizations have described the rapid emergence of drug-resistant bacteria as a “crisis” or “nightmare scenario.” In 2013, the CDC stated that people are now in the ‘post-antibiotic era’ and in 2014, WHO warned that the antibiotic resistance crisis is becoming dire.