Killer eye drops recall: What to know and the brands affected

A flurry of US deaths and blindness caused by contaminated eyedrops has caused panic nationwide.

Three Americans have died, eight have suffered vision loss and four people have 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 eyedrops from the Indian manufacturer Global Pharma, which have been recalled while health officials investigate. 

Most patients reported using 10 different brands of artificial tears, but EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multi-dose bottles, was the brand most commonly reported.

What do we know about the outbreak?

As of March 14, a reported 68 patients in 16 states have been infected with this ‘rare strain’ of Pseudomonas aeruginosa, according to the Centers for Disease Control and Prevention (CDC)

Which eye drop brands 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 using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears.

Last month, the manufacturer Global Pharma recalled the drops that had been sold at major drug stores across the country, including Walmart, Target, and CVS, and on Amazon. 

It issued a second recall later in February of Delsam’s Artificial Eye Ointment ‘due to possible microbial contamination.’

A possible cause of the contamination is a lack of preservatives in the EzriCare and Delsam Pharma’s artificial tears. 

The FDA said the company failed to adequately test its products for bacterial contamination and packaged them without adequate preservatives, a safeguard for products to prevent the growth of bacteria in the event of contamination.

Earlier this month, two other companies recalled some of their products. Florida-based Apotex voluntarily recalled six lots of its prescription Brimonidine Tartrate Ophthalmic Solution, 0.15 percent on March 1 because at least four bottle caps developed cracks, jeopardizing their sterility.

And on March 3, Pharmedica recalled its Purely Smoothing 15 percent MSM Drops ‘due to non-sterility.’

What are the symptoms of an eye infection?

There are plenty of signs of eye infection to watch out for. Common symptoms include yellow, green, or clear discharge from the eye, blurry vision, discomfort or the feeling of something in the eye, sensitivity to light, and redness of the eye or eyelid.

Some of the horror stories related to the use of the recalled drops are just that. Horrible. A recent case study published this week in JAMA Ophthalmology reported on a 72-year-old woman who suffered vision loss in the left eye for one 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 from an infection of the cornea. It later improved, but he still has vision issues. He had not experienced previous eye problems but after using EzriCare artificial tears for eye dryness, he had 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 in the hospital for three weeks enduring IV antibiotics, antibiotic eye drops and multiple surgical interventions

In another case, a 72-year-old man had a severe infection in his eye, left. Although it had improved a month later, right, he still experienced 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 from the man’s cornea and EzriCare bottle grew the same strain of multidrug-resistant Pseudomonas.

In some extreme cases, the infection can spread elsewhere in the body, including in the bloodstream. Three people have died from infection, eight people have lost their vision 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 various reasons from dry eye syndrome to glaucoma. The risk to the public appears low overall, and even lower for people who use eye drops with preservatives.

Dr Thomas Steinemann, clinical spokesperson for the American Academy of Ophthalmology told CNN: ‘There are millions and millions of people that 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’s probably very little concern and they shouldn’t stop using their eye medicines or even their over-the-counter preparations… Most drops on the market have preservatives in them that would counteract that threat [of bacteria multiplying and spreading in the eye.]’

What went wrong?

The CDC is carrying on its investigation into the issue alongside the FDA and state governments. The 16 states where patients have been infected include 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 that 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 from as far back as May 2022. The agency will also continue to test unopened bottles.

The agency still does not know if the drops were contaminated during the manufacturing process or after they left the factory, possibly due to cracked caps that let in dangerous bacteria.

Is this a wider problem?

The current outbreak could be symptomatic of larger manufacturing issue at the India-based eyedrop maker Global Pharma Healthcare Private Limited. The FDA added the company to its list of banned imports last month, citing several manufacturing regulation violations, including a ‘lack of proper controls concerning tamper-evident packaging’ and a ‘lack of appropriate microbial testing.’

The incident stemming from Global Pharma comes just a few months after a governmental committee in Gambia slammed India-based drug maker 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 contained toxic levels of diethylene and ethylene glycol and should be withdrawn. The drugs were pulled from the shelves and Maiden’s production license in India was suspended.

Meanwhile, in Uzbekistan last year, at least 19 children died after consuming cough syrup made by 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 pediatric dose.

A separate but equally important growing global problem is the rise of treatment-resistant bacterial infections brought on by a number of causes including overuse and overprescribing, a lack of new antibiotics entering the market, and ingesting the antibiotics used for farming and livestock. 

A growing list of infections such as TB, pneumonia, blood poisoning, gonorrhoea, and foodborne diseases, are becoming harder, and sometimes impossible, to treat as antibiotics become less effective. 

Many public health organizations have described the rapid emergence of resistant bacteria as a ‘crisis’ or ‘nightmare scenario’. In 2013, the CDC declared that humans are now in the ‘post-antibiotic era,’ and in 2014, the WHO warned that the antibiotic resistance crisis is becoming dire.