CNN
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A rare strain of bacteria found in recalled eye drops has been linked to dozens of infections, including vision loss, surgical removal of eyeballs and one death.
Artificial Tears Lubricant Eye Drops distributed by Global Pharma Healthcare’s EzriCare and Delsam Pharma were first withdrawn from the market at the beginning of February.
In an update this week, the U.S. Centers for Disease Control and Prevention identified 68 patients in 16 states with infections from a rare drug-resistant strain of 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.
Adverse events reported on March 14 include corneal, circulatory, respiratory, and urinary tract infections. There are eight reports of vision loss and four reports of surgically removed eyeballs. Earlier it was 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 develop 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 photosensitivity; and blurred vision.
Global Pharma initiated a voluntary recall last month, with the FDA recommending the recall due to manufacturing violations, including the lack of proper microbial testing and packaging in multi-use bottles without adequate preservatives.
In addition to artificial tears, the FDA recommended on February 22 that Global Pharma recall Delsam Pharma’s artificial eye cream due to bacterial contamination, which the company agreed to.
The company did not respond to CNN’s request for comment on Friday.
More recalls of eye drops have also been reported recently, although so far they are not related to adverse events.
Pharmedica USA is recalling two lots of anti-inflammatory Pure Sedative 15% MSM Drops “due to non-sterility,” according to a March 3 FDA notice. The company announced that it had not received any reports of adverse events or illnesses related to the product.
The company advises consumers to stop using the eye drops immediately 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 website.
Apotex is recalling six batches of Brimonidine Tartrate Ophthalmic Solution 0.15% prescription eye drops, which are used to treat open-angle glaucoma or ocular hypertension. The company says the recall is out of “an abundance of caution” because some bottle caps have cracks that could affect sterility and lead to adverse events.
According to the FDA’s March 1 announcement, no infections have been reported with the product. Individuals who purchased products with identified lots listed on the FDA website should immediately contact their healthcare provider for medical advice and call 1-855-275-1273 to arrange for a return.
Neither company responded to CNN’s request for comment on Friday.
Dr. Thomas Steinemann, clinical spokesperson for the American Academy of Ophthalmology, says eye drops are safe when prepared and used correctly.
“There are millions and millions of people in the United States who use eye drops safely and successfully for a variety of reasons,” Steinemann said. “I want to emphasize that the average user of eye drops probably has very little to worry about and should not stop using eye medications or even over-the-counter products.”
However, Steinemann points out that these reminders emphasize the importance of using eye drops safely. For example, patients should be careful with preservative-free eye drops, such as EzriCare Artificial Tears, because contamination can lead to serious infection.
“Once they’re contaminated or bacteria gets into the bottle, the bacteria can multiply and even transfer the bacteria back into the eye,” he said. “Most drops on the market have preservatives to prevent this threat.”
Other ways to prevent eye infections include washing your hands before touching the bottle or the eye, avoiding touching the tip of the bottle to your eyelashes and skin, and not using expired eye drops.