The US Centers for Disease Control and Prevention has reported an additional death and 6 more cases of blindness linked to infections caused by eye drops that were recalled because they contained bacterial contamination.
In total, four deaths and fourteen cases of blindness have been reported in more than 80 infections caused by a drug-resistant strain of Pseudomonas aeruginosa. This strain had never before been detected in the United States. The CDC also reported that four eyeballs were surgically removed.
The CDC reported that patients used more than ten different brands of eyedrops. Most commonly, they were EzriCare Artificial Tears. Global Pharma Healthcare's Artificial Tears Lubricant Eye Drops distributed by EzriCare & Delsam Pharma were recalled for the first time in February.
The CDC released an update on Wednesday, identifying 13 additional patients in two more states. This brings the total of 81 patients across 18 states.
Seven of the thirteen newly identified patients were collected from specimens taken after recalls on eye products. Most of these seven patients either used the recalled eye drops or lived in long-term facilities where other cases of bacterial infection were present.
The US Food and Drug Administration and CDC has urged consumers to cease using the recalled product.
The CDC stated that patients who use artificial tears from EzriCare and Delsam Pharma, but who show signs or symptoms of eye infection should see a doctor immediately.
The symptoms can include yellow or green discharge, eye pain or discomfort, redness or swelling of the eyelid or eye and feeling as if something is inside the eye. Other symptoms may include increased light sensitivity or blurred vision.
According to the CDC, Pseudomonas aeruginosa can spread to people without symptoms and even to those who have not used eye drops. This type of spread occurs most often in health care facilities.
The bacteria can spread if a patient with the bacteria touches a common item or if healthcare workers pass the germs on. This is why infection prevention, such as hand hygiene, are so important.
In an April inspection report, the FDA stated that Global Pharma Healthcare in India failed to follow the proper protocol in order to prevent contamination of their products.
The FDA conducted an 11-day facility inspection, which began in mid-February. This was 2 1/2 weeks after EzriCare Artificial Tears were recalled by the company due to contamination.
The FDA made 11 observations during the inspection of Global Pharma's facility, including that the'manufacturing processes lacked assurance that the product was sterile', specifically for batches that were manufactured and shipped to the US between December 2020 and March 2022.