CNN
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A rare strain of bacteria found in recalled eye drops has been linked to dozens of infections, as well as cases of vision loss, surgical removal of eyeballs and one death.
Global Pharma Healthcare’s Artificial Tears Lubricant Eye Drops, distributed by EzriCare and Delsam Pharma, were first recalled in early February.
In an update this week, the US Centers for Disease Control and Prevention identified 68 patients in 16 states with infections by a rare strain of drug-resistant Pseudomonas aeruginosa that had never before been reported in the United States. Most patients reported using artificial tears, the CDC said. Although patients reported using different brands, EzriCare Artificial Tears was the most commonly reported brand.
Reported side effects per March 14 includes infections of the cornea, bloodstream, respiratory tract and urinary tract. There are eight reports of vision loss and four reports of surgically removed eyeballs. It has previously been reported that one person has died.
The US Food and Drug Administration and the CDC have urged consumers to stop using the recalled products.
“Patients who have used EzriCare or Delsam Pharma artificial tears and who have signs or symptoms of an eye infection should seek immediate medical attention,” the CDC said. Symptoms may include yellow, green, or clear discharge from the eye; eye pain or discomfort; redness of the eye or eyelid; feeling that something is in the eye; increased sensitivity to light; and blurred vision.
Global Pharma initiated a voluntary recall last month, and the FDA recommended the recall due to manufacturing violations, including a lack of adequate microbial testing and being packaged in reusable bottles without adequate preservatives.
In addition to artificial tears, the FDA recommended on February 22 that Global Pharma recall Delsam Pharma’s artificial eye ointment due to concerns about bacterial contamination, which the company accepted.
The company did not respond to CNN’s request for comment Friday.
Several recalls of eye drops have also been announced recently, although so far they have not been linked to adverse events.
Pharmedica USA is recalling two lots of anti-inflammatory Pure Calming 15% MSM drops due to “non-sterility,” according to the March 3 FDA notice. The company said it had received no reports of adverse events or illness related to the product.
The company advises consumers to immediately stop using the eye drops and return them to the place of purchase. Consumers with questions about the recall can call Pharmedica USA at 1-623-698-1752, which can be found on the FDA’s website.
Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% – prescription eye drops used to treat open-angle glaucoma or ocular hypertension. The company says the recall is out of “an abundance of caution” due to cracks in some bottle caps that could affect sterility and lead to adverse events.
No infections have been reported with the product, according to the March 1 FDA announcement. Individuals who purchased products with the identified lots listed on the FDA website should immediately contact their healthcare provider for medical advice and call 1-855-275-1273 to arrange a return.
Neither company responded to CNN’s request for comment Friday.
Dr. Thomas Steinemann, clinical spokesman for the American Academy of Ophthalmology, says eye drops are safe when they are made and used correctly.
“There are millions and millions of people using eye drops safely and successfully in the United States for a variety of reasons,” Steinemann said. “I would like to stress that for the average eye drop user there is probably very little to worry about and they should not stop using their eye medication or even their over the counter medication.”
However, Steinemann notes that these recalls highlight the importance of safe use of eye drops. For example, patients should be careful with preservative-free eye drops, such as EzriCare artificial tears, as contamination can lead to serious infection.
“Once they’re contaminated or bacteria gets into the bottle, then obviously there’s a source for bacteria to multiply and even transfer bacteria back into the eye,” he said. “Most drops on the market have preservatives in them that would counteract this threat.”
Other ways to prevent eye infections include washing your hands before touching the bottle or your eye, avoiding touching the tip of the bottle to eyelashes and skin, and not using expired eye drops.