FDA says to stop using 2 popular eye drop products, citing serious health risks
The Food and Drug Administration (FDA) is issuing a warning to consumers to immediately cease the use of two eye drop products: “Dr. Berne’s MSM Drops 5% Solution” and “LightEyez MSM Eye Drops – Eye Repair.” This is due to concerns about potential bacterial or fungal contamination which could lead to severe health hazards, including infections that can threaten vision and even life. Interestingly, no reports have been made to the FDA about anyone experiencing issues because of these products.
Earlier in the year, the FDA had cautioned against the use of several other eye drop brands. This previous warning was tied to an outbreak of a strain of drug-resistant bacteria, which had been associated with at least four fatalities across 18 states and numerous infections.
The company “Dr. Berne’s Whole Health Products” is responsible for distributing the Dr. Berne’s products, and “LightEyez Limited” handles the distribution of LightEyez items.
Tests conducted by the FDA revealed that these products had microbial contamination and weren’t sterile, a prerequisite as stipulated under the Federal Food, Drug, and Cosmetic Act. Moreover, both products, which haven’t been given approval and are thus being illegally promoted in the U.S., include methylsulfonylmethane (MSM) as a primary ingredient. The FDA has not given the green light for MSM to be used in eye drop formulations.
The Centers for Disease Control and Prevention (CDC) indicated that there’s been an increase in the number of Americans getting infected due to such contaminated products. Elaborating on the risks, the FDA highlighted that using tainted eye drops could trigger a range of complications, from minor vision issues to critical, life-endangering infections.
In response to these concerns, Dr. Berne has proactively initiated a voluntary recall of its MSM Drops 5% Solution. On the other hand, LightEyez Limited, based in London, has neither communicated with the FDA nor taken measures to safeguard consumers. The FDA’s investigations uncovered that the product from LightEyez was polluted with Pseudomonas aeruginosa. This bacterium can trigger infections in multiple body parts, including the blood and lungs. It’s believed that a drug-resistant variant of this bacterium is the cause behind the deaths and health issues related to the contaminated eye drops.
In a related development from earlier in the year, Global Pharma Healthcare had initiated a recall of all lots of its EzriCare and Delsam Pharma brands of “Artificial Tears Lubricant Eye Drops” over concerns of bacterial contamination.
As of now, LightEyez hasn’t given any comments or response to CBS MoneyWatch’s request for a statement.