Edhat Staff
By the edhat staff
The U.S. Food and Drug Administration (FDA) has issued a warning regarding the use of two eyedrop products due to bacterial and fungal contamination. The affected products are Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops Eye Repair.
The contamination involves drug-resistant bacteria Pseudomonas aeruginosa, Mycobacterium, Mycolicibacterium, and Methylorubrum in LightEyez, and Exophiala fungi in Dr. Berne’s product.
Both products claim methylsulfonylmethane (MSM) as their active ingredient, which is not authorized for use in any legally marketed eye drugs in the U.S. So far, no adverse effects have been reported by consumers who have used these products, according to the FDA.
This warning comes as the U.S. Centers for Disease Control and Prevention (CDC) revealed an outbreak of Pseudomonas aeruginosa infections linked to several brands of artificial tears and eyedrop products. The CDC identified the bacteria strain in 81 individuals, with four deaths reported between May 2022 and April 2023. Notably, the most common product associated with the infections was Ezri Care Artificial Tears, which the FDA warned against purchasing in February.
The CDC confirmed the presence of the matching Pseudomonas aeruginosa strain in open bottles of Ezri Care Artificial Tears, leading to further investigation to determine if contamination occurred during the manufacturing process. The FDA attributed the lack of appropriate microbial testing and the use of inadequate, tamper-evident packaging to the manufacturer, Global Pharma Healthcare, an India-based pharmaceutical provider. Global Pharma also voluntarily recalled another product, Delsam Pharma Artificial Eye Ointment, for similar reasons.
In February, two other companies, Apotex Corp. and Pharmedica USA, recalled their eyedrop products. At that time, those products had not been linked to infections. However, as of May, infections related to the outbreak were reported in 18 states across the U.S., including California, Texas, New York, and Florida.
Symptoms of the bacterial infection include eye discharge, redness, blurred vision, light sensitivity, and eye pain. In severe cases, the infection can spread to other parts of the body, including the bloodstream, leading to potential vision loss or surgical removal of the eyeball.
Treatment typically involves antibiotics, but the increasing resistance of the bacteria to multiple drugs poses a challenge. The CDC currently recommends testing for infection only in individuals exhibiting symptoms. In recent years, drug-resistant strains of Pseudomonas aeruginosa have caused thousands of infections among hospitalized patients, prompting concerns about the need for effective measures to address this ongoing issue.
As the FDA urges consumers to cease the use of the affected products and investigates the contamination, vigilance and caution when choosing eyedrop products are paramount.
YIKES! Thank you.