by
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 U.S. Centers for Disease Control and Prevention identified 68 patients in 16 states with infections from 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 a variety of brands, EzriCare Artificial Tears was the most commonly reported brand.
Reported side effects as of March 14 include infections of the cornea, bloodstream, respiratory tract, and urinary tract. There are eight reports of lost vision and four reports of surgically removed eyeballs. It was previously reported that one person has died.
The U.S. Food and Drug Administration and 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 photosensitivity; and blurred vision.
Global Pharma initiated a voluntary recall last month, and the FDA recommended the recall due to manufacturing violations, including the lack of proper microbial testing and the fact that they are packaged in multi-dose bottles without adequate preservatives.
In addition to artificial tears, the FDA recommended on Feb. 22 that Global Pharma recall Delsam Pharma’s artificial eye ointment over concerns of bacterial contamination, to which the company agreed.
The company did not respond to CNN’s request for comment on Friday.
More eye drop recalls have also been announced recently, although they have not been linked to side effects so far.
Pharmadica USA is recalling two lots of anti-inflammatory Purely Soothing 15% MSM Drops due to “non-sterility,” according to the March 3 FDA announcement. The company said it had not received any reports of side effects or illness 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 Pharmadica USA at 1-623-698-1752, listed on the FDA website.
Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% – prescription eye drops for the treatment of open-angle glaucoma or ocular hypertension. The company says the recall is out of “an abundance of caution” because of cracks in some of the bottle caps that could affect sterility and lead to side effects.
According to the March 1 FDA announcement, no infections with the product have been reported. Individuals who have purchased products containing 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 spokesperson for the American Academy of Ophthalmology, says eye drops are safe when manufactured and used properly.
“There are millions and millions of people who use eye drops safely and successfully in the United States for a variety of reasons,” Steinemann said. “I want to emphasize that for the average eye drop user, there are probably few concerns and they shouldn’t stop using their eye medications or even their over-the-counter preparations.”
However, Steinemann notes that these recalls emphasize the importance of using eye drops safely. 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 get into the bottle, there’s clearly a source for bacteria to multiply and even put bacteria back into the eye,” he said. “Most drops on the market contain preservatives that would counteract that threat.”
Other ways to avoid eye infections include washing your hands before touching the bottle or your eye, avoiding touching the tip of the bottle to the eyelashes and skin, and not using eye drops that have passed their expiration date.
