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 tear lubricating 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 of a rare, drug-resistant strain of Pseudomonas aeruginosa that had never been previously reported to the United States. 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 as of March 14 include corneal, bloodstream, respiratory and urinary tract infections. There are eight reports of vision loss and four reports of surgically removed eyeballs. It has already 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 eye infection should seek medical attention immediately,” the CDC said. Symptoms may include yellow, green, or clear eye discharge; eye pain or discomfort; redness of the eye or eyelid; having the impression that there is something in the eyes; increased sensitivity to light; and blurred vision.
Global Pharma issued a voluntary recall last month, and the FDA recommended the recall due to manufacturing violations, including 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 ointment due to bacterial contamination concerns, which the company has accepted.
The company did not respond to CNN’s request for comment on Friday.
Other eye drop recalls have also been announced recently, although they have not been linked to adverse events so far.
According to the March 3 FDA announcement, Pharmedica USA is recalling two lots of Purely Soothing 15% MSM Anti-Inflammatory Drops due to “non-sterility”. The company said it has not received any reports of adverse events or illnesses 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 Phmedica USA at 1-623-698-1752, provided on the FDA 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 an “excess of caution” due to cracks in some bottle caps which may impact sterility and lead to adverse effects.
No infections have been reported with the product, according to the March 1 FDA announcement. Individuals who have 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 Friday to CNN’s request for comment.
Dr. Thomas Steinemann, clinical spokesperson for the American Academy of Ophthalmology, says eye drops are safe when made and used correctly.
“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 stress that for the average eye drop user, there is probably very little concern and they shouldn’t stop using their eye medications or even over-the-counter preparations. ”
However, Steinemann notes that these reminders underscore the importance of safe use of eye drops. For example, patients should exercise caution with preservative-free eye drops, such as EzriCare artificial tears, as contamination can lead to serious infection.
“Once they get contaminated or bacteria get into the bottle, there is obviously a source for bacteria to multiply and even transmit bacteria into the eye,” he said. “Most drops on the market contain preservatives that 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.